Corporate Updates

Roche’s Evrysdi continues to improve motor function and survival in babies with Type 1 Spinal Muscular Atrophy

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics

Exelixis ; U.S. FDA accepts investigational new drug application for XB002 in patients with Advanced Solid Tumors

New drug for treating advanced tumour under investigation

Hansa Biopharma enters preclinical research collaboration with Argenx

The preclinical research collaboration agreement with argenx BV is to evaluate the therapeutic potential of combining the two companies' IgG-modulating technologies.

GSK and Vir Biotechnology requests emergency use authorization to FDA for VIR-7831 for treatment of COVID-19

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE

GSK and Vir Biotechnology requests emergency use authorization to FDA for VIR-7831 for treatment of COVID-19

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE

ProBioGen enters into agreement with Nobelpharma for manufacturing process development of their vaccine Project

EU tightens export curbs over COVID-19 vaccines in bid to avoid shortfall

European Member countries are struggling to contain a third wave of the epidemic

Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617

The study is aimed for patients with advanced prostate cancer

Pfizer Initiates Phase 1 Study of Novel Oral Antiviral Therapeutic Agent Against SARS-CoV-2

Oral antivirals promise hassle-free treatment of Covid patients

Boston Pharmaceuticals Enters into Unique Multi-Year Out-License and Option Agreement with GSK

The agreement is for the advancement of multiple pre-phase 2 programs

Fujitsu Embarks on Joint Research with National Cancer Center Japan

The joint research is aimed to create new services for drug development and clinical trials

Precigen Receives FDA Orphan Drug Designation for PRGN-2012 Adenoverse

The drug is used for immunotherapy in patients with Recurrent Respiratory Papillomatosis (RRP)

ProBioGen licenses GlymaxX Technology to Sanofi

GlymaxX enables a boost of antibody-dependent cell-mediated cytotoxicity (ADCC)

Cytocom receives FDA clearance of IND for Phase 2 clinical trial of CYTO-205 as treatment for COVID-19

Latest FDA News Update

BioVaxys enters into a major bioproduction agreement with Wuxi Biologics (Hong Kong) Ltd.

FDA Grants Fast Track Designation to Spectrum Pharmaceuticals’ Poziotinib

Poziotonib was also presented at European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021

Takeda acquires Maverick Therapeutics for around $ 525 million benefit

Takeover to advance T-Cell Activator Solid Tumor Treatments and expand new Cancer Immunotherapy Portfolio

ConserV Bioscience and eTheRNA immunotherapies to collaborate on development of mRNA Vaccines

Pharma collaboration update

Madhya Pradesh reports 440 fresh COVID cases

Coronavirus spike reported in MP

Tempest Therapeutics announces clinical collaboration with Roche to advance TPST-1120

the collaboration is for a randomized combination study in first-line Hepatocellular Carcinoma

U.S. FDA expands approval of Pfizer’s LORBRENA as first-line treatment for ALK-Positive Metastatic Lung Cancer

In 2018, the FDA approved LORBRENA for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease

Debiopharm grants exclusive license to Merck for Xevinapant

This worldwide exclusive license to Merck KGaA, Darmstadt, Germany for the development and commercialization of Xevinapant

Sorrento receives USFDA clearance to start a clinical trial of Anti-CD47 antibody

Sorrento receives USFDA clearance to start a clinical trial of Anti-CD47 Antibody, discovered from fully human G-MAB library, for treatment of multiple malignancies

Strides receives USFDA approval for Ibuprofen OTC Oral Suspension

Ibuprofen will be manufactured at the company’s facility at Bengaluru

Soleno Therapeutics announces collaboration with Vanderbilt University

This collaboration aims to discover and develop novel KATP channel activators with the potential to treat rare diseases

Oncology Pharma extends licensing agreement with NanoSmart Pharmaceuticals, Inc. for veterinary oncology

This collaboration will improve the field of the animal healthcare industry

Glenmark’s launches Ryaltri innovative single nasal spray in Russia

This is Glenmark’s first global brand launch of a convenient single spray option for patients

Twist Bioscience collaborates with Berry Gene, will jointly develop a new portfolio of NGS products

This collaboration can provide a variety of NGS detection solutions

NovalGen enters strategic partnership with HALIX B.V. to manufacture clinical trial materials

Within the scope of this partnership, HALIX will provide manufacturing of clinical supply of NovalGen’s therapies

Lilly and Rigel enter strategic collaboration to develop RIPK1 Inhibitors

The inhibitor is for the potential treatment of Immunological and Neurodegenerative diseases

NMPA Approves Toripalimab in patients with recurrent or metastatic Nasopharyngeal Carcinoma

Approval comes after Failure of at Least Two Lines of Prior Systemic Therapy

Compugen expands clinical collaboration agreement with Bristol Myers Squibb

Compugen Ltd expands collaboration agreement with Bristol Myers Squibb with phase 1b combination study of COM701 with opdivo C

Unichem received ANDA approval from USFDA for Apremilast Tablets

Another ANDA approval for Unichem Lab

Eurofins Scientific acquired Beacon Discovery to significantly strengthen its expertise in drug discovery

Eurofins acquired Beacon Discovery for its innovative approach, years of experience in drug discovery and development

BeiGene reports FDA approval for Brukinsa(Zanubrutinib )

Brukisa is indicated for the treatment of adult patients with Waldenström’s Macroglobulinemia

EMERCell signs strategic partnership with Onward Therapeutics

EMERCell signs strategic partnership with Onward Therapeutics for the development of its NK cell therapy technology

Avexegen Therapeutics receives a $2.94M NIH Grant to advance treatment for Inflammatory Bowel Disease

Pharma Funding Update

Lupin Launches Posaconazole Delayed-Release Tablets

Lupin & its AET Pharma US Inc. (part of Tiefenbacher Group) received an approval for its ANDA from the USFDA

Molecular Templates establishes multi-target collaboration with Bristol Myers Squibb

Molecular Templates collaborates with Bristol Myers Squibb for the discovery and development of next generation engineered toxin bodies

Forge Biologics receives USFDA fast track, orphan drug, and rare pediatric disease designations

Forge Biologics receives FDA fast track, orphan drug, and rare pediatric disease designations for FBX-101 gene therapy for patients with krabbe disease

Sanofi's mRNA vaccine would not be available this year ; CEO

It could be of use at a later stage all the more if the fight against variants was to continue, said the CEO

Evonik strengthens strategic partnership with BioNTech on COVID-19 vaccine

This move marks an expansion of the strategic partnership between Evonik and the vaccine manufacturer BioNTech

Roche receives first USFDA clearance for urine sample type for BK virus quantitative test

Roche receives first USFDA clearance for urine sample type for BK virus quantitative test to aid in the improvement of care for transplant patients

Novartis receives FDA Breakthrough Therapy designations for STAMP inhibitor asciminib (ABL001)

Novartis receives FDA Breakthrough Therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukaemia

Feb 24 is scheduled for health workers who have missed the Covid-19 vaccination

Mop Up vaccination scheduled on Feb 24 and completion by March 1

LupinLife Launches Be One, Ayurvedic Energy Supplement

Be One is a natural, non-addictive and steroid-free daily health supplement for men

The McQuade Center for Strategic Research and Development collaborates with Eikonizo Therapeutics

The McQuade Center for Strategic Research and Development and Eikonizo Therapeutics enter agreement to develop treatments for patients with are diseases

Daiichi Sankyo enters into outsourcing agreement to manufacture AstraZeneca COVID-19 Vaccine in Japan

Daiichi Sankyo will use undiluted solutions provided by AstraZeneca to manufacture COVID-19 vaccines in Japan

Bain, Cinven buy Lonza Specialty Ingredients in $4.7 billion deal

Lonza’s shares rose more than 60% last year, as it expanded in drugs and prepared to unload Specialty Ingredients.

Zydus Cadila receives final approval from USFDA for Liothyronine Sodium Tablets

Liothyronine is a man-made form of thyroid hormone which is used to treat an underactive thyroid (hypothyroidism).

Pfizer and Biontech publish results of study showing COVID-19 vaccine elicits antibodies that neutralize Pseudovirus bearing the SARS-COV-2 U.K

While the pseudovirus system used is a surrogate for authentic SARS-CoV-2, previous studies have shown excellent concordance between pseudotype neutralization and SARS-CoV-2 neutralization assays.

FUJIFILM Diosynth Biotechnologies begins production of two COVID-19 vaccines

FUJIFILM Diosynth Biotechnologies announced that production has begun in Texas on two different COVID-19 vaccine candidates with support from the U.S. government

Tessa Therapeutics receives PRIME designation from EMA for CD30 CAR-T Therapy

Tessa announced, EMA has granted PRiority MEdicines designation to the company's lead autologous CD30 CAR-T therapy for the treatment of relapsed or refractory classical Hodgkin Lymphoma

The RSA Group welcomes Eleanor Davies as Managing Partner

The RSA Group announces the appointment of a new senior team member. Eleanor Davies joins the company as Managing Partner

Sirnaomics announces first patient dosed In phase 2a study of STP705

The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA

GSK presents positive efficacy data of dostarlimab in mismatch repair-deficient solid cancers at ASCO Gastrointestinal Cancers Symposium

GSK plc announced updated data from GARNET cohort F evaluating dostarlimab in mismatch repair-deficient non-endometrial advanced solid cancers being presented today at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

Enhertu approved in the US for the treatment of patients with previously treated HER2-positive advanced gastric cancer

In the US, gastric cancer is most frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving beyond five years.

Revive Therapeutics collaborates with North Carolina State University to develop Psilocybin

Revive Therapeutics announces research collaboration with North Carolina State University for natural biosynthesis enzymatic platform to develop psilocybin

Janssen received U.S. FDA approval for DARZALEX FASPRO

Genmab announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Jubilant Therapeutics Announces Research Collaboration with The Wistar Institute to Evaluate the Activity of Novel PAD4 Inhibitors

“This collaboration with Jubilant Therapeutics will further advance our comprehensive research efforts to find therapeutics to diminish cytokine storms and decrease COVID-19 symptom gravity,” said Yulia Nefedova.

Knopp Biosciences announces results from the phase 2 EXHALE trial of oral Dexpramipexole Eosinophilic Asthma

New drug for eosinophilic asthma on the way

AtraZeneca's Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer

New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience

ViiV Healthcare receives EU Marketing Authorisation for Tivicay, a treatment for children living with HIV in Europe

Tivicay contains dolutegravir, an integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV

PFIZER’S XALKORI APPROVED BY USFDA FOR ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA IN CHILDREN AND YOUNG ADULTS

XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people

Strides receives USFDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Truvada Tablets, 200 mg/300 mg, of Gilead Sciences

ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay

“Today’s authorisation is a really important milestone towards enabling children to have access to age-appropriate formulations of HIV medicine," said Deborah Waterhouse, CEO of ViiV Healthcare

Pfizer invests $120 million in biotechnology innovation through the Pfizer breakthrough growth initiative

Through PBGI, Pfizer is investing up to $500 million in biotechnology companies, providing funding and access to Pfizer’s scientific expertise to help ensure the continuity of promising clinical development programs of potential future strategic interest to Pfizer.

Sanofi to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L

KY1005 binds to OX40-Ligand and has the potential to treat a wide variety of immune-mediated diseases and inflammatory disorders.

U.S. FDA Accepts for Priority Review the Biologics License Application for V114

Merck announced the U.S. FDA accepted for priority review a Biologics License Application for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease.

Vir Biotechnology and GSK announce NHS-supported AGILE study to evaluate VIR-7832 in the early treatment of COVID-19

Vir Biotechnology, Inc. and GlaxoSmithKline plc today announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in Phase 1b/2a clinical trial

Sanofi to acquire Kymab, adding KY1005 to its pipeline

Sanofi and Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics

GSK, MMV filing for Kozenis in paediatric populations with Plasmodium vivax malaria accepted by Australian Therapeutic Goods Administration

The application includes data for a new, 50 mg tablet that can be dispersed in water and which was developed to facilitate use in children, who are disproportionately affected by the disease.

Serum Institute of India obtains emergency use authorisation in India for AstraZeneca’s COVID-19 vaccine

AstraZeneca’s COVID-19 vaccine has been granted emergency use authorization in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunization of adults.

Pfizer doses first participants in phase 3 study for Duchenne Muscular Dystrophy investigational Gene Therapy

CIFFREO is a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study.

Lupin Receives Tentative Approval for Empagliflozin and Metformin Hydrochloride ER Tablets

Empagliflozin and Metformin Hydrochloride Extended-Release (ER) Tablets, are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.

Farxiga granted Priority Review in the US for the treatment of patients with chronic kidney disease

Farxiga could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with and without type-2 diabetes

Lupin Receives Approval for Sulfamethoxazole and Trimethoprim Oral Suspension USP

Sulfamethoxazole and Trimethoprim Oral Suspension, is indicated for the treatment and prevention of a wide variety of bacterial infections.

US FDA accepts regulatory submission from PFIZER and OPKO for review of somatrogon

Pfizer inc. and OPKO Health Inc. announced today that the USFDA has accepted for filing the initial Biologics License Application for somatrogon, a long-acting human growth hormone for the treatment of pediatric patients with growth hormone deficiency.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo

“The EMA’s decision to validate our application represents important progress for the esophageal cancer community, and we look forward to potentially bringing Opdivo to patients in the EU who may benefit.”

RedHill Biopharma Announces Positive Top-Line Safety and Efficacy Data from Phase 2 COVID-19 Study of Opaganib

Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms

Glenmark receives ANDA final approval for Tadalafil Tablets

Glenmark has also received tentative approval by the U.S. FDA for Gabapentin Enacarbil Extended-Release Tablets, the generic version of Horizant 1of Arbor Pharmaceuticals.

US FDA accepts Alkermes' resubmission of new drug application for ALKS 3831

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder

Moleculin announces Annamycin receives USFDA orphan drug designation for soft tissue sarcomas

Annamycin is capable of reaching 6 to 34-fold higher levels of accumulation in the lungs than that of doxorubicin, the primary first-line chemotherapy for STS

Pfizer's LORBRENA sNDA in previously untreated ALK-positive lung cancer accepted for priority review by U.S. FDA

LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumour mutations that drive resistance to current medications and to address brain metastases

Lupin launches Meloxicam Capsules, received approval from USFDA

Meloxicam Capsules indicated for the management of osteoarthritis pain

LYNPARZA (olaparib) Receives Three New Approvals in Japan

LYNPARZA has been approved in Japan for the treatment of three types of advanced cancer: ovarian, prostate and pancreatic cancer.

Innovent Biologics announces the NMPA granted new indication approval for BYVASDA

BYVASDA is an anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody and a bevacizumab biosimilar independently developed by Innovent Biologics

Lupin launches Meloxicam Capsules

Meloxicam Capsules is the generic equivalent of Vivlodex Capsules of Zyla Life Sciences US, Inc., and indicated for the management of osteoarthritis (OA) pain.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Zeposia (ozanimod) for the Treatment of Ulcerative Colitis

If approved, Zeposia would be the first oral sphingosine-1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis.

First Subject Dosed with Gannex's FXR Agonist ASC42 in a U.S. Phase I Trial

ASC42 received Fast Track designation from the US FDA for NASH

WuXi Biologics receives GMP certification from Brazil's ANVISA

The positive assessment from ANVISA reaffirms WuXi Biologics' strong commitment to offering partners a global manufacturing network of the highest standard

Elevar Therapeutic collaborates with Inceptua Group for commercialization of Apealea in Europe

Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe

Innovent Biologics announces NMPA of China granted new indication approvals for SULINNO

Innovent announces NMPA granted new indication approvals for SULINNO (Adalimumab Injection) for the treatment of pediatric plaque psoriasis and non-infectious uveitis

PFIZER AND BIONTECH TO SUPPLY THE U.S. WITH 100 MILLION ADDITIONAL DOSES OF COVID-19 VACCINE

“With these 100 million additional doses, the United States will be able to protect more individuals and hopefully end this devastating pandemic more quickly,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

Amryt Pharma received orphan drug designation by the US FDA for AP103

AP103 is based on Amryt's gene-therapy platform technology and offers a potential treatment for patients with DEB

PE-backed GenWorks acquires in-vitro unit of Mumbai-based healthcare firm

In the latest example of companies using the pandemic to strengthen their offerings, healthcare solutions provider GenWorks Health Pvt Ltd has acquired the in-vitro unit of a Mumbai-based healthcare firm.

Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458

The pharma company continues to plan for a mid-2021 launch of JZP-458 following completion of the BLA submission and US FDA review and approval.

Bristol Announces Update on Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed Methylated Glioblastoma Multiforme

“Glioblastoma is an aggressive cancer with a very poor prognosis that has seen limited new treatment options over the last 15 years,” said Michael Mandola, Ph.D., Oncology Development Program Lead, Bristol Myers Squibb.

Glenmark Pharmaceuticals and Menarini enter into Exclusive Licensing Agreement for commercializing Ryaltris Nasal Spray

“We are excited to partner with Menarini for Ryaltris™ across Europe as they have a proven track record in partnering and commercializing respiratory products in the region, " said Achin Gupta, Executive Vice President, Business Head EMEA-L, Glenmark Pharmaceuticals

European Commission approves Roche’s Phesgo for people with HER2-positive breast cancer

Subcutaneous administration is preferred by patients, physicians and healthcare providers, and is associated with a reduction in healthcare costs

Aurinia Pharmaceuticals collaborates with Lonza for dedicated voclosporin manufacturing capacity

The collaboration will help keep the manufacturing costs down and ensure long-term flexibility to meet future demand for years to come

Merck Announces Supply Agreement with U.S. Government for Initial Doses of Investigational Biological Therapy for the Treatment of COVID-19

"Building upon the promising clinical findings to date for MK-7110, Merck is pleased to be collaborating with the U.S. Government to advance the manufacture and distribution of this candidate for patients with serious COVID-19 disease," said Dr. Roger M. Perlmutter, president, Merck Research Lab.

Glenmark collaborates with Menarini for commercializing Ryaltris nasal spray across Europe

The licensing agreement will be effective in 33 countries throughout the European region including France, Italy, and Spain

Gamma Biosciences collaborates with Astrea Bioseparations for advanced application of Avacta Affimer Reagent Technology

The agreement that gives Astrea the ability to secure exclusive access to the Affimer technology for applications in bioprocessing

Sosei Heptares collaborates with GlaxoSmithKline targeting immune disorders of the digestive system

GSK licenses global rights to a portfolio of GPR35 agonists designed by Sosei Heptares using its StaR technology and structure-based drug design platform

Revive Therapeutics announces LOI to acquire PharmaTher’s psilocybin program

Revive Therapeutics to acquire the full rights to PharmaTher Inc.’s intellectual property pertaining to psilocybin

RedHill's phase 2/3 COVID-19 study of opaganib passes second DSMB with unanimous recommendation to continue

Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication

Update on SOURCE Phase III trial for tezepelumab in patients with severe, oral corticosteroid-dependent asthma

Tezepelumab’s effect on other efficacy parameters was similar to those observed in previous trials, including the registrational Phase III NAVIGATOR trial.

Dr. Reddy's, Global Response Aid, and Appili Therapeutics announce the filing of an application for REEQONUS Tablets

Dr. Reddy’s Canada has filed an application on behalf of the consortium for REEQONUS Tablets for the acute treatment of mild to moderate COVID-19 adult patients

COVID-19 / FluA, B / RSV test without extraction from Seegene now available in Europe

The company also expressed confidence that the addition of the new feature will enable labs around the world to use test kits more widely

Sirnaomics reports positive data from phase 2a study of STP705 for treatment of squamous cell skin cancer

The primary endpoint of this trial was to evaluate patients for complete histological clearance of the tumour cells within the treated isSCC lesion

Thermo Fisher scientific expands clinical supply chain services in Europe

Today’s clinical supply chain and logistics market in Europe is expected to double by 2025 and more than triple by 2030

Glenmark Pharmaceuticals receives ANDA tentative approval for Dabigatran Etexilate Capsules

Glenmark has received tentative approval by the United States Food & Drug Administration for Dabigatran Etexilate Capsules, the generic version of Pradaxa 1 Capsules

ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe

This authorization represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets

Tagrisso approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

Approval based on unprecedented results from the ADAURA Phase III trial where Tagrisso reduced the risk of disease recurrence or death by 80%

Enesi Pharma collaborates with Imperial College London to develop thermostable RNA vaccines

The ability to create such vaccines could minimize or eliminate the cold chain requirements for global deployment and mass vaccination programmes with RNA-based vaccines

NATCO launches anti blood clot tablet Rivaroxaban in India

Rivaroxaban is currently sold by Bayer under the brand name of Xarelto, in the Indian market.

CNS Pharmaceuticals announces USFDA approval of IND application for its brain cancer drug candidate Berubicin

CNS Pharma will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA

“Patients with newly diagnosed esophageal and GEJ cancer face an aggressive disease with a poor prognosis, despite the currently available treatment options.”

Blueprint Medicines submits sNDA to USFDA for AYVAKIT for the treatment of advanced systemic mastocytosis

Blueprint Medicines requested priority review for this application, which, if granted, could result in a six-month review process

DayToDay Health builds a virtual healthcare system for COVID-19 Patients

Remote healthcare is an ideal solution for the nearly 80% of coronavirus patients presenting with non-critical symptoms

Vir Biotechnology and GSK announce start of NIH-sponsored ACTIV-3 trial evaluating VIR-7831 in hospitalized adults with COVID-19

ACTIV-3 is an NIH-led public-private partnership designed to accelerate the development of the most promising treatments and vaccine candidates for COVID-19.

Lupin receives approval from US FDA for Colesevelam Hydrochloride tablets

Another USFDA approval for Lupin

Strides Pharma receives USFDA approval for Oxybutynin Chloride Tablets

The medication is used to treat overactive bladder and urinary conditions

FDA approves GSK’s BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US

BENLYSTA is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease.

ABBOTT STRENGTHENS STRUCTURAL HEART PORTFOLIO WITH NEW CLIP DELIVERY SYSTEM

Abbott has launched its clip delivery system, a minimally invasive heart valve repair device to treat mitral regurgitation in India.

Cadent Therapeutics enters agreement to be acquired by Novartis

The acquisition will give Novartis full rights to Cadent’s neuroscience portfolio

Biocon Biologics signs an MoU with CSSC in Tanzania for Mission 10 cents

Tanzania will be the first country in Africa that will benefit from this collaboration between Biocon Biologics and CSSC.

Zai Lab partner MacroGenics announces US FDA approval of MARGENZA for patients with pretreated metastatic HER2-positive breast cancer

The approval for MARGENZA was based on data from SOPHIA, a randomized Phase 3 clinical trial

The RedHill Phase II / III candidate opaganib reduces ARDS-related blood clotting in the preclinical model in COVID-19 patients

The results also show that opaganib inhibits SARS-CoV-2 virus replication and proinflammatory markers in relevant preclinical models

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA

Patients with newly diagnosed esophageal and GEJ cancer face an aggressive disease with a poor prognosis, despite the currently available treatment options

KEYTRUDA Plus LENVIMA Combination Demonstrated Statistically Significant Improvement in Overall Survival

“Women with advanced endometrial cancer are faced with high mortality rates and limited treatment options following initial systemic therapy.”

Gilead and Galapagos announce new commercialization and development agreement for Jyseleca

Gilead and Galapagos will continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease

Greenwich LifeSciences announces option agreement for pre-clinical Coronavirus vaccine candidates

Greenwich LifeSciences collaborates with Westport Bio to in-license a pre-clinical coronavirus vaccine program that is currently at the stage of pre-clinical animal testing

Fortress Biotech announces US FDA has granted breakthrough therapy designation for CUTX-101

Fortress Biotech declares US FDA has granted breakthrough therapy designation for CUTX-101, Copper Histidinate, for the treatment of Menkes Disease

Cipla Launches ‘CIPtest’ Rapid Antigen Detection Test for COVID-19 Diagnosis

CIPtest is a reliable high-performing kit that has been validated and approved by ICMR.

Eli Lilly announces agreement to acquire Prevail Therapeutics

The acquisition will establish a new modality for drug discovery and development at Lilly

Sanofi renews partnership with the WHO to fight Neglected Tropical Diseases

Sanofi renewed a partnership agreement with the WHO, consolidating a 20-year collaboration to fight some of the most Neglected Tropical Diseases

Imfinzi recommended for approval in the EU by CHMP for non-small cell lung cancer

This new dosing option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer and once approved, will be available to patients with locally advanced, unresectable NSCLC weighing more than 30kg.

Trastuzumab deruxtecan recommended for approval in the EU by CHMP for HER2-positive metastatic breast cancer

The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year.

Trixeo Aerosphere approved in the EU for maintenance treatment of COPD

COPD is a progressive disease, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness and is the third leading cause of death globally.

BAVENCIO receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma

This year US FDA has approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC

The Lancet: New polio vaccine against safe and generates immune response in adults, young children, and infants

Phase 2 trials in 1,200 adults, young children, and infants suggest new poliovirus vaccine may have the potential to overcome outbreaks caused by a mutated polio strain linked to the oral vaccine that typically circulates in areas of low immunisation coverage, and poses one of biggest barriers to eradication

Cipla announces settlement of revlimid (lenalidomide) capsules patent litigation

Cipla wins the litigation case against Bristol Myers Squibb

CHMP recommends approval of Plavix with aspirin in adults for certain types of strokes

CHMP issues positive opinion for use of Plavix with aspirin in adults within 24 hours of minor ischemic stroke or high-risk transient ischemic attack

Crescendo Biologics expands its ongoing collaboration with Takeda

This collaboration will help Crescendo’s proprietary transgenic platform and engineering expertise are being used to build Humabody-based therapeutics against certain targets selected by Takeda

Entera Bio announces US FDA approval of IND application for EB613

Entera Bio receives US FDA approval of IND application for EB613 – an oral human parathyroid hormone (1-34) for the treatment of osteoporosis

ViiV Healthcare announces positive CHMP opinion for Rukobia, for the treatment of adults with multidrug-resistant HIV

Fostemsavir addresses a critical unmet need in HIV care for those with little to no treatment options left.

Bristol Myers Squibb Announces Settlement of U.S. Patent Litigation for REVLIMID with Cipla

Bristol Myers Squibb today announced that its wholly-owned subsidiary, Celgene, and Cipla have settled their litigation related to patents for REVLIMID.

Bristol Myers Squibb Receives Positive CHMP Opinion for Inrebic for Adult Patients with Myelofibrosis

If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in nearly a decade.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA as First-Line Treatment for Metastatic Microsatellite Instability

“Patients in Europe with MSI-H/dMMR colorectal cancer have had only chemotherapy-containing regimens available to them in the first-line treatment setting and have historically faced poor outcomes,” said Dr. Vicki Goodman.

Alembic Pharmaceuticals announces USFDA Final Approval for Asenapine Sublingual Tablets

Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.

Twist Bioscience expands gene product line with launch of Clonal-Ready Gene Fragments

It can be used to build constructs and minimize the time and cost of screening for perfect clones

Real-time logistics monitoring from Roambee proven to address COVID-19 vaccine distribution challenges

Roambee offers full traceability and transparency by delivering a complete chain of custody, a chain of condition and chain of shipment integrity report with every shipment

Thermo Fisher Scientific expands global footprint for drug product development and commercial manufacturing

The investments will add 15 development and cGMP commercial production lines, leveraging Thermo Fisher's robust quality standards

Enhertu continues to demonstrate durable responses with new data from DESTINY-Breast01 in HER2

Enhertu continued to demonstrate impressive efficacy and durable responses in patients with HER2-positive metastatic breast cancer following two or more prior HER2-based regimens.

PeptiDream announces strategic partnership and license option agreement with Amolyt Pharma

This collaboration will help both companies to work together to test and further optimize PeptiDream’s Growth Hormone Receptor Antagonist“GHRA” peptide candidates

AZD1222 Oxford Phase III trials interim analysis results published in The Lancet

Interim analysis showed vaccine is effective at preventing COVID-19, with no severe cases and no hospitalizations more than 21 days after first injection

U.S. FDA ACCEPTS FOR PRIORITY REVIEW THE BIOLOGICS LICENSE APPLICATION FOR PFIZER’S INVESTIGATIONAL 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

The FDA’s acceptance of our application for 20vPnC is yet another significant milestone in Pfizer’s continuing efforts to help protect adults against pneumococcal disease,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer.

Zydus granted fast track designation by the USFDA for Saroglitazar in the treatment of patients with PBC

Fast Track is a process of the USFDA which expedites the review of drugs to treat serious conditions and fill an unmet medical need

United Therapeutics receives US FDA orphan drug designation for Treprostinil for the treatment of IPF

Phase 3 TETON study planned in 2021 for Tyvaso in patients with idiopathic pulmonary fibrosis

US FDA accepts GSK’s filing of Nucala for use in chronic rhinosinusitis with nasal polyps

If approved, Nucala would be the only treatment approved in the US for use in four eosinophil-driven diseases.

PFIZER REPORTS POSITIVE CLINICAL DATA FOR BCMA-CD3 BISPECIFIC ANTIBODY IN MULTIPLE MYELOMA

“Despite treatment advances, multiple myeloma remains incurable and there is a substantial need for breakthroughs for patients,” said Jeff Settleman.

PostEra and Pfizer collaborate to promote machine learning for Drug Discovery

Through collaboration companies will leverage Pfizer's extensive data and experience with PostEra's technological resources to promote the science of generative chemistry

Bristol Myers Squibb Presents Analyses from Pivotal QUAZAR AML-001 Study of Onureg

Results demonstrated treatment with Onureg improved overall survival, compared to placebo, in patients with AML in first remission.

Jubilant Therapeutics announces Efficacy and Biomarker Data at 62nd ASH Annual Meeting for its Novel Dual LSD1-HDAC6 Inhibitor

"We believe JBI-802 could one day serve as a powerful therapeutic agent for the treatment of specific cancers, including myelodysplastic syndrome, select acute myeloid leukemia and solid tumor subsets.”

Fermenta Biotech USA, LLC acquires 52% interest in AGD Nutrition LLC

The deal would combine the expertise of both companies and result in synergies that will bring in greater operational capabilities to enhance FBL’s footprint in the US market

Calquence data across four trials reinforces cardiovascular safety profile for chronic lymphocytic leukaemia

"Cardiac adverse events have emerged as an important consideration for treating chronic lymphocytic leukaemia patients with Bruton’s tyrosine kinase inhibitors"

Kronos Bio announces US FDA clearance of IND application for KB-0742

The company plans to begin a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumours in the first quarter of 2021

Indoco wins major tenders in Germany for Allopurinol Tablets

Indoco manufactures Allopurinol API at its new API manufacturing site at Patalganga.

Zydus announces Phase I trials of ZYIL1, a novel oral small molecule NLRP3 inflammasome inhibitor

Zydus, today announced that it has received permission to initiate the Phase 1 clinical trial of ZYIL1, a novel oral small molecule NLRP3 inhibitor candidate.

PFIZER AND SANGAMO ANNOUNCE UPDATED PHASE 1/2 RESULTS FOR HEMOPHILIA A GENE THERAPY

We continue to be encouraged by the findings from this Phase 1/2 study, which now include durable factor VIII expression through one year of follow-up, and we look forward to continuing to follow these patients

New follow-up phase III data reinforce the long-term benefit of Roche’s Hemlibra for people with haemophilia A

Results showed that Hemlibra’s safety profile was consistent with previous observations and no new safety signals were observed after the longer follow-up

Antengene announces acceptance of IND application in China

Antengene announces acceptance of IND application in China for ATG-010 (selinexor) in combination with R-GDP (SR-GDP) for the treatment of rrDLBCL in a global phase 2/3 study

Corvus Pharmaceuticals provides new data on its investigational ITK inhibitor CPI-818

CPI-818, an oral interleukin-2-inducible T-cell kinase inhibitor, is well-tolerated and active in patients with T-cell lymphoma

Sinovac secures approximately $500 million in funding for COVID-19 vaccine development

Sinovac expects to be able to manufacture 300 million doses annually and aims to complete the construction of a second production facility by the end of 2020

KaliVir Immunotherapeutics collaborates with Astellas for development and commercialization of VET2 -L2 novel oncolytic virus

This collaboration, which combines KaliVir's expertise in the development of oncolytic viruses with Astellas' capabilities in advanced drug development

Calquence shows long-term efficacy and tolerability at three years for refractory mantle cell lymphoma

Patients with relapsed or refractory mantle cell lymphoma (MCL) treated with Calquence (acalabrutinib) remained progression-free for a median of 22 months.

PureTech starts phase 2 trial of LYT-100 in long COVID-19 respiratory complications and related sequelae

PureTech’s global, randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate the efficacy, safety and tolerability of LYT-100 in adults with post-acute COVID-19 respiratory complications

FlowMetric launches breakthrough COVID-19 antibody test

FlowMetric introduces a powerful advancement in COVID-19 antibody testing that delivers exceptional performance compared to existing tests on the global market today, including the ELISA gold standard.

I-Mab accelerates clinical development of anti-CD47 monoclonal antibody lemzoparlimab in the US and China

I-Mab's global collaboration with AbbVie will facilitate global development of lemzoparlimab

US FDA approves Saxenda for the treatment of obesity in adolescents aged 12-17

Novo Nordisk is offering a new treatment option for adolescents with obesity and their families in the US

Moderna announces amendment to supply agreement of COVID vaccine with the ministry of health of Israel

This agreement will support the ongoing efforts by the Ministry to secure early access to a COVID-19 vaccine for the people of Israel

PharmaEngine, Inc. collaborates with Sentinel Oncology for SOL-578, a Chk1 inhibitor

PharmaEngine, Inc. and Sentinel Oncology Limited enter into an exclusive collaboration and license agreement for SOL-578, a Chk1 inhibitor

Rhizen Pharmaceuticals Announces US FDA Acceptance of its IND Application

Rhizen today announced the approval of IND application by the U.S. FDA to study its oral DHODH inhibitor for SARS-CoV-2 infection.

ReAlta Life Sciences Announces EMA Orphan Drug Designation for RLS-0071 for the Treatment of Neonatal Encephalopathy

The EMA grants orphan status to medicinal products intended to treat rare disorders that affect fewer than 5 people per 10,000 in the European Union

Zydus receives approval from DCGI to commence Phase III clinical trials with Pegylated Interferon alpha-2b in India

Zydus Cadila, had received an approval from the Drugs Controller General of India to start the Phase 3 clinical trial in COVID-19 patients with its biological therapy

I2O Therapeutics receives strategic investment from Colorcon Ventures

Colorcon will collaborate with i2O to accelerate i2O’s research and development efforts

Alembic Pharmaceuticals announces USFDA Final Approval for Metolazone Tablets

Metolazone Tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.

Roche receives USFDA emergency use authorization for new test to measure the level of SARS-CoV-2 antibodies

This test may help identify recovering patients who could potentially be serum and plasma donors for developing treatments for COVID-19

Roche announces FDA approval of Gavreto for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations

Alembic Pharmaceuticals announces USFDA Final Approval for Metolazone Tablets USP

Alembic has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from USFDA

Nordic Nanovector completes patient enrolment into Phase 1 trial of Betalutin in Diffuse Large B Cell Lymphoma

Nordic Nanovector's primary focus is the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line follicular lymphoma

Agena Bioscience announces high-throughput, low-cost panel for molecular detection of SARS-CoV-2, Influenza A, and Influenza B

Agena also aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or assay availability

PFIZER AND BIONTECH ACHIEVE FIRST AUTHORIZATION IN THE WORLD FOR A VACCINE TO COMBAT COVID-19

“The Emergency Use Authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19"

Dr. Reddy's and RDIF commence clinical trials for Sputnik V vaccine in India

This will be a multicenter and randomized controlled study, which will include a safety and immunogenicity study.

Caris Life Sciences announces Vall d´Hebron Institute of Oncology joins its precision oncology alliance

The Alliance is a collaborative network of leading cancer centers that work together to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology through research

Boston Scientific signs definitive agreement to divest BTG specialty pharmaceuticals business

Boston Scientific Corporation today announced that it has entered into a definitive agreement with Stark International Lux, to sell its BTG Specialty Pharmaceuticals business

Takeda completes sale of select OTC and non-core assets to Celltrion in Asia Pacific

Takeda Pharmaceutical Company Limited completes its previously-announced sale of a portfolio of select products to Celltrion Inc

Crestor to be divested to Grünenthal in Europe

AstraZeneca has agreed to sell the rights to Crestor and associated medicines in over 30 countries in Europe, except the UK and Spain.

Marinomed Biotech AG announces clinical trial at Swansea University Medical School to investigate efficacy of Carragelose in preventing COVID-19

Objective of the study is to assess the efficacy of Carragelose nasal and throat spray in reducing the rate, severity, and duration of COVID-19 infections

Lupin receives approval from USFDA for Penicillamine Tablets USP

Penicillamine Tablets USP, 250 mg, are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis

Glenmark Pharmaceuticals receives ANDA tentative approval for Axitinib Tablets

According to IQVIA sales data for the 12 month period ending October 2020, the Inlyta Tablets market achieved annual sales of approximately $518.8 million*.

Dupixent approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis

Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating, and severe disease can significantly impact many aspects of life for both children and their families.

Hon'ble Prime Minister of India, Shri Narendra Modiji's inspiring presence at the Zydus Biotech Park

Hon'ble Prime Minister's leadership vision, in-depth understanding and knowledge of the facts guided us in facilitating the interactions and discussions on the vaccines and therapeutics for COVID-19

Eisai collaborates with Wren Therapeutics for drug discovery for Synucleinopathies

The collaboration will use Wren's network kinetics drug discovery platform, alongside Eisai's extensive experience in drug discovery for neurodegenerative disorders

SAL unveils new pharma and perishable facilities in Riyadh in time for COVID vaccines distribution

The new facilities also feature a 650 sqm temperature control breakdown area and fully prepared to handle COVID-19 vaccines once it’s ready for distribution

Vertex Pharma received European Commission Approval for SYMKEVI With KALYDECO

The only medicine to treat the underlying cause of CF in this age group with one F508del mutation and one of 14 residual function mutations

Eppendorf SmartBlock for cell thawing: reproducible and reliable process

The new exchangeable thermoblockSmartBlockcryo thaw provides a dedicated thawing program for a reproducible and reliable thawing of cells from frozen storage conditions to +37 °C

Co-Diagnostics JV CoSara Diagnostics receives clearance from CDSCO for COVID-19 2-Gene Multiplex Test

The pharma company is geared up by providing affordable, high quality, 'Made in India' 2-gene multiplex COVID-19 RT-PCR tests across the country

PostEra and NeuroLucent collaborate on identifying small-molecule therapeutics for Alzheimer's disease

NeuroLucent has partnered with PostEra to accelerate its search for a therapeutic candidate

Apollo Hospitals, Bangalore has introduced Robotic Assisted Joint Replacement Program

The Robotic system has an advanced computed program that relays precise information about the knee with 3D mapping.

Astellas receives approval of EVRENZO in Japan for the treatment of anemia of chronic kidney disease

This approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis

AstraZeneca's signs MoU with Indian Diabetes Research Society to empower 1 Crore Indian Diabetic patients by 2023

AstraZeneca unveiled a campaign-'Beyond Sugar', a three-year patient awareness program developed to benefit over 1 Crore people living with Diabetes across the country

BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

The majority of the work will be completed in 2021 to start clinical trials as early as possible during 2022

Senhwa submitted multiple IND application to US FDA and Health Canada for the treatment of solid tumours

Senhwa announces multiple IND application submissions to US FDA and Health Canada evaluating its investigational drug, CX-5461, for the treatment of patients with solid tumours with BRCA2 or PALB2 mutations

Glenmark Pharmaceuticals secures its position in the prestigious Dow Jones Sustainability Emerging Markets Index

DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top-ranked companies in terms of Corporate Sustainability within each industry featured in the index.

Laurus Labs forays into biotech, acquires majority stake in Richcore Lifesciences

Laurus Labs to acquire 72.55 per cent of Richcore’s shares for a value of Rs 246.7 crores

Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Tentative Approval for Testosterone Gel

Testosterone Gel, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Piramal Sarvajal and Center for Water and Sanitation Launch Composite Water Vulnerability Index Tool

Piramal Sarvajal, the safe drinking water initiative of Piramal Foundation launched a tool named Composite Water Vulnerability Index at its recent Webinar on ‘Sustainable Water Security for Urban Under-Served’.

Bristol Myers Squibb Receives European Commission Approval for Opdivo

Bristol Myers Squibb announced the approval of Opdivo for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma

Lupin launches Tacrolimus Capsules USP

Tacrolimus Capsules are the generic equivalent of Prograf Capsules of Astellas Pharma US, Inc. and are indicated for the prophylaxis of organ rejection.

Lokelma label update approved in China for patients with hyperkalaemia on chronic haemodialysis

The NMPA has approved a dosing label update in China for AstraZeneca’s Lokelma to include patients with hyperkalaemia on chronic haemodialysis.

BioNTech and Fosun Pharma announce the start of phase 2 clinical trial of COVID-19 Vaccine in China

The vaccine's clinical study not only provides key data for the launch of the vaccine in China, but also may play a positive role in the widespread promotion and use of the vaccine throughout Asia and around the world

Bausch Health Initiates Second Phase 3 Study For NOV03 Investigational Treatment For Dry Eye Disease

NOV03 showed statistically significant improvement of certain symptoms, such as severity and frequency of dryness and burning/stinging of the eyes

ISD Immunotech collaborates with Biogen Inc for the development of a novel lupus treatment

ISD and Biogen will work together to develop ISD's lead compound, ISD 017, which is being developed to treat severe lupus - systemic lupus erythematosus (SLE)

CytoDyn collaborates with amfAR to accelerate HIV cure research

The amfAR Foundation for AIDS Research, to test the ability of Vyrologix (leronlimab) to mediate a functional HIV cure

Acquisition adds to Merck’s suite of clinical programs in response to SARS-CoV-2/COVID-19

Meaningful new therapeutic options are desperately needed for possibly millions of people around the world who will develop severe or critical COVID-19 disease

Merck Submits Applications for Licensure of V114, the Company’s Investigational 15-valent Pneumococcal Conjugate Vaccine

“These submissions for V114 help bring us closer to offering more options to help protect against pneumococcal disease."

European Commission approves MenQuadfi, the latest innovation in meningococcal vaccination

The EC has approved MenQuadfi for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.

PFIZER DOSES FIRST PARTICIPANT IN PHASE 3 STUDY EVALUATING ANTI-TFPI INVESTIGATIONAL THERAPY

An anti-tissue factor pathway inhibitor being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors.

Recently published data on Favipiravir as treatment for mild to moderate COVID-19 demonstrates significant improvement in time to clinical cure

The oral antiviral medication Favipiravir, which prevents the replication phase of the virus life-cycle, leads to significant improvement in clinical cure in patients with mild to moderate COVID-19.

Regeneron's REGEN-COV2 is first antibody cocktail for COVID-19 to receive US FDA emergency use authorization

The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis

AbCellera-discovered antibody granted interim authorization by health Canada as a treatment for COVID-19

Bamlanivimab received emergency use authorization (EUA) from the U.S. Food and Drug Administration on November 9, 2020

AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19

Strides receives USFDA approval for Prednisone Tablets

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Deltasone Tablets of Pharmacia and Upjohn Co.

RedHill announces DSMB unanimous recommendation to continue COVID-19 opaganib phase 2/3 study

The independent, pre-programmed DSMB unanimously recommends the continuation of the global Phase 2/3 study of orally administered opaganib in severe COVID-19 pneumonia

GSK starts phase 3 study of RSV maternal candidate vaccine

Currently no vaccine is available for respiratory syncytial virus

RedHill Biopharma initiates phase 3 study of RHB-204 for first-line treatment of NTM disease

RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease

Orchard Therapeutics announces US FDA clearance of IND application for OTL-200 for metachromatic leukodystrophy

The company believes that OTL-200 offers tremendous potential to transform the lives of many young patients with MLD

Eli Lilly collaborates with Precision BioSciences for genome editing research

This collaboration will help to accelerate the work aimed to solve genetic diseases with unique editing challenges

PerkinElmer introduces non-invasive sample collection for COVID-19 testing

Non-invasive sample collection and batch processing to test symptomatic and asymptomatic individuals – a breakthrough in COVID-19 testing

GSK and MMV present positive data on treatment for Plasmodium vivax malaria in children

GSK and MMV today presented positive data from the TEACH study of tafenoquine, an 8-aminoquinoline, for the prevention of relapse of Plasmodium vivax malaria in children and adolescents.

Ixlayer introduces technology to accelerate the safe distribution of forthcoming COVID-19 vaccine

The COVID-19 Vaccine Administration Platform simplifies the complex coordination required to move vaccines the last mile

PharmaTher enters into research collaboration with Revive Therapeutics

PharmaTher Inc collaborates with Revive Therapeutics for psilocybin and panaceAI psychedelic discovery AI platform

RESULTS FROM PHASE 3 CROWN TRIAL OF PFIZER’S LORBRENA IN PREVIOUSLY UNTREATED ALK-POSITIVE LUNG CANCER PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

“The results from the CROWN trial demonstrate that LORBRENA has the potential to be a practice-changing, first-line option, and we thank the many people and their families who participated in this trial.”

QIAGEN N.V. announced a strategic collaboration with BioNTech SE

QIAGEN collaborates with BioNTech on companion diagnostics development for HPV-associated squamous cell carcinoma of the head and neck

India's indigenous solution to COVID-19 in progress

Monoclonal antibody leads for COVID-19: A way forward In combating COVID-19

ABBOTT STRENGTHENS STRUCTURAL HEART PORTFOLIO WITH NEW CLIP DELIVERY SYSTEM FOR NON-INVASIVE TREATMENT OF LEAKY MITRAL VALVES

Clinical evidence for this device demonstrates safety and efficacy for people suffering from mitral regurgitation

Readout Health collaborates with Apollo Health for the management of neurodegenerative disease

BIOSENSE gains a clinical partner in the journey to support therapeutic nutritional ketosis research in key chronic disease categories

Corvia Medical completes randomization in REDUCE LAP-HF II pivotal trial

Corvia Medical completes randomization in REDUCE LAP-HF II pivotal trial and gains US FDA authorization to provide continued access for the Corvia Atrial Shunt L

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

Collaboration with the Bill & Melinda Gates Foundation Seeks to Bring Forward a New HIV Prevention Option with Focus on Women

Lupin Pharma, announces US FDA has accepted their new drug application for solosec for the treatment of trichomoniasis

If approved for trichomoniasis, Solosec could be the only single-dose oral prescription treatment for both BV and trichomoniasis

Eisai receives approval for indication expansion of anti-epileptic agent fycompa for use in pediatric patients

The approval was based on the results of Phase III and Phase II clinical studies conducted globally to evaluate Fycompa as an adjunctive therapy in pediatric patients with POS or PGTCS

Lead Pharma Collaborates with Roche to develop oral small molecules for immune mediated diseases

R&D collaboration building on Lead Pharma's expertise in the discovery, design and optimization of small molecule treatments

Croda International Plc collaborates with Pfizer for innovative delivery system for COVID-19 vaccine

Croda International has recently entered into an agreement with Pfizer Inc. to supply novel excipients used in the manufacture of a COVID-19 vaccine candidate

Akers Biosciences and MyMD Pharmaceuticals sign definitive merger agreement

Through this merger, the company will be able to deliver novel, multi-indication platform drugs designed to extend healthy lifespan and treat the source of chronic autoimmune diseases

NATCO receives Pomalidomide approval for US market

Celgene, sells Pomalidomide Capsules under the Brand name POMALYST, for the treatment of patients suffering from multiple myeloma cancer

ViiV Healthcare announces CHMP positive opinion for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe

Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children

AlpVision to offer free of charge security feature to protect COVID-19 relevant medicines against counterfeiting

This initiative supports pharmaceutical companies by providing them for free with the necessary tools to protect COVID-19 relevant medicines and vaccines against counterfeiting

Lupin’s Alliance Partner Concord Receives U.S. FDA Approval for Tacrolimus Capsules USP

Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants

Medicago and GSK announce start of Phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate

"Our Phase 1 results of the adjuvanted vaccine candidate were very encouraging and fully support further clinical evaluation.”

Update on CALAVI Phase II trials for Calquence in patients hospitalised with respiratory symptoms of COVID-19

CALAVI did not meet the primary endpoint of increasing the proportion of patients who remained alive and free of respiratory failure

Jubilant Therapeutics and OneThree Biotech Collaborate to Advance Precision Oncology

“The convergence of biology and scalable data science is enabling new approaches to de-risk early-stage programs through biomarker discovery and patient selection,” said Syed Kazmi.

Avicenna.AI collaborates with Canon Medical on AI stroke detection

The collaboration will provide the customers with AI solutions that help them to improve the quality of care

Glenmark Pharmaceuticals receives ANDA approval for Tacrolimus Capsules

Glenmark has been granted final approval by the U.S. FDA for Tacrolimus Capsules USP, the generic version of Prograf Capsules, of Astellas Pharm US, Inc.

TCR² Therapeutics collaborates with ElevateBio to expand manufacturing capacity

The strategic partnership will focus on the production of TC-210, TCR2’s TRuC-T cell targeting advanced mesothelin-expressing cancer, to support demand for the anticipated Phase 2 clinical trial

KEYTRUDA plus LENVIMA met the trial’s primary endpoint of progression-free survival

LENVIMA plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma

Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma

AstraZeneca and Amgen today announced positive results from the new medicine tezepelumab in patients with severe, uncontrolled asthma.

PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla

Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia

Calquence demonstrated superior progression-free survival and favorable tolerability in both previously untreated and relapsed or refractory patients

EIP Pharma Announces Presentation of Positive Clinical Trial Results with Neflamapimod

Results were presented at the 13th Clinical Trials in Alzheimer's Disease (CTAD) Meeting

TaiGen Biotechnology partners with GPCR Therapeutics

This collaboration will position these companies to be a pre-eminent developer of anti-CXCR4 oncology drugs

Standard Chartered and Piramal Sarvajal more than double their Commitment to Provide Access to Safe Drinking Water; will Benefit 300,000 lives

This integrated water management solution will be implemented across 75 villages, half of which will be in aspirational districts

China's Porton Biologics launches gene and cell therapy CDMO platform

The pharma company aim to build a world-leading R&D and production platform depending on core talents and technical skills

Merck to acquire VelosBio

This acquisition is well positioned to achieve its maximum potential to benefit appropriate cancer patients in need

Brilinta approved in the US to reduce the risk of stroke in patients with an acute ischaemic stroke or high-risk transient ischaemic attack

New indication expands use of Brilinta beyond the cardiovascular disease to patients with mild-to-moderate stroke

Jubilant Pharma Ltd. and Aavis Pharmaceuticals launch Hydroxychloroquine Sulfate tablets in the U.S. market

“We are pleased to announce the commercial launch of Hydroxychloroquine Sulfate tablets in the U.S. through our marketing partner.” stated Ashok Barot

Thermo Fisher Scientific partners with Innoforce to establish drug manufacturing facility in China

Joint venture expands global pharma services capacity for drug development and manufacturing

LYNPARZA Approved in the EU for Treatment of BRCA1/2-Mutated Metastatic Castration-Resistant Prostate Cancer

Only PARP Inhibitor to Demonstrate Overall Survival Versus New Hormonal Agent Treatments in BRCA1/2-Mutated mCRPC

ATG Pharma has signed a partnership with Evolve Ltd

ATG Pharma enters European market

Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer

Lynparza in combination with bevacizumab demonstrated as a treatment for the treatment of HRD-positive advanced Ovarian Cancer

RCPE awarded two US FDA contracts for next-generation pharma technology

This development represents a landmark achievement for RCPE and reflects the potential impact of these projects within the global pharma industry

Lumis International GmbH spins off its consulting business to Lumis Life Science Consulting GmbH

The foundation of Lumis Consult allows Lumis to expand its consulting business in a major strategic step.

Fast Track designation facilitates development of new therapies that treat serious conditions and fulfill unmet needs for patients

LogicBio Therapeutics Receives FDA Fast Track Designation for LB-001 for the Treatment of Methylmalonic Acidemia (MMA)

ImmunoPrecise Antibodies and Mila announce strategic AI partnership

The collaboration will leverage data and AI to transform how novel therapeutics are discovered and developed

Zydus announces IND filing of ZYIL1, a novel oral small molecule NLRP3 inflammasome inhibitor

NLRP3 inflammasome inhibitor can selectively modulate the inflammatory responses caused by the ‘Cytokine Storm’ in Acute Respiratory Distress Syndrome

Dabur ‘Immunity Vans’ bring Ayurvedic medicines at your Doorstep

These specially designed vans, which is part of Dabur’s direct-to-consumer ‘Immunity at your Doorstep’ initiative, have been deployed across 10 cities in India

Align Technology to Award Research Programs Advancing Orthodontic and Dental Patient Care

Align Technology, today announced the opening of its 2021 Research Award Program to support clinical and scientific dental research in universities across the globe.

Apollo Hospitals, Indore has successfully performed Central India’s first Renal Denervation Therapy

Dr. K Roshan Rao, Head of the Cardiology Department quoted that incidentally this procedure was done on World Hypertension day.

Janssen submits new drug application to U.S. FDA for treatment of schizophrenia in adults

If approved, PP6M will be the first and only long-acting injectable (LAI) schizophrenia medication with a twice-yearly dosing regimen

Janssen submits new drug application to U.S. FDA for treatment of schizophrenia in adults

If approved, PP6M will be the first and only long-acting injectable (LAI) schizophrenia medication with a twice-yearly dosing regimen

Recombia Biosciences collaborates with Lesaffre for innovative gene editing technology

This partnership also signifies Lesaffre's entry into the world of Synthetic Biology, considered to be the major biotechnological opportunity of this decade

AGC Biologics and Horizon Therapeutics plc expand partnership

The collaboration offers to customers in need of high volume commercial production

Thermo Fisher Scientific extends collaboration with Symphogen

The extension of the collaboration is a natural way forward to continue driving innovation in the discovery and development of highly differentiated cancer therapeutics

Roche receives US FDA approval for the cobas EGFR mutation test v2

Roche receives FDA approval for the cobas EGFR mutation test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer

Genprex receives conditional US FDA acceptance for the treatment of non-small cell lung cancer

Genprex receives conditional FDA acceptance of proprietary name REQORSA for lead drug candidate for the treatment of non-small cell lung cancer

Reddy's partners with Department of Biotechnology for Sputnik V vaccine clinical trials in India

Dr. Reddy’s announced its partnership with Biotechnology Industry Research Assistance Council, Department of Biotechnology, Government of India, for advisory support on clinical trials of Sputnik V vaccine in India.

Fasenra eliminated oral corticosteroid use in a majority of OCS-dependent patients with asthma

PONENTE Phase IIIb open-label trial showed Fasenra eliminated the use of maintenance oral corticosteroids in OCS-dependent asthma patients with a broad range of blood eosinophil counts.

Takeda collaborates with Moderna to supply COVID-19 vaccine in Japan

Takeda expands COVID-19 vaccine supply in Japan through partnership with Moderna and Government of Japan

Dupixent reports safe administrations for young patients with moderate-to-severe atopic dermatitis

These data reinforce the well-established long-term safety profile of Dupixent in moderate-to-severe atopic dermatitis.

Santen and Aerie signed exclusive agreement for Rhopressa and Rocklatan in Japan and Several Other Asian Countries

Both the pharma companies aim to further contribute to the treatment of glaucoma patients through these products

CStone and LegoChem Biosciences enter into global licensing agreement

This partnership puts LCB71 in a path to development and commercialization for patients around the world

Sensorion and Novasep announce signature of a gene therapy product development and manufacturing agreement

The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein. Mutations in OTOF lead to severe or profound congenital hearing loss

Taysha Gene Therapies Receives Rare Pediatric Disease Designation and Orphan Drug Designation for TSHA-104

Leigh syndrome is characterized by progressive loss of mental and movement abilities that can result in death within two to three years

Cipla launches ‘ELIFast’ for COVID-19 antibody detection

Cipla will be responsible for the marketing and distribution of the SARS CoV-2-IgG antibody detection ELISA that will be manufactured by KARWA Ltd.

Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer

Only HER2-directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy

Piramal Pharma Consumer Products Division’s Tri-Activ Disinfectant Spray For Multi-Surfaces is 99.9% Effective Against the Covid-19 Virus in 1 Minute

This spray has been tested and proven for efficacy as well as fast action on the Covid19 virus by an independent accredited US-based lab.

FDA GRANTS PRIORITY REVIEW AND EMA ACCEPTS REGULATORY SUBMISSION FOR PFIZER’S ABROCITINIB FOR PATIENTS WITH ATOPIC DERMATITIS

“Atopic dermatitis is a serious, unpredictable, and often debilitating condition that can have a significant impact on the daily lives of patients and their families,” said Michael Corbo.

Knight Therapeutics signs a new distribution agreement with Gilead Sciences

The agreement will enter into force as of 1st January 2021

TFF Pharmaceuticals expands its cGMP manufacturing capabilities with Experic

The expansion will increase TFF’s manufacturing capacity, as well as provide a third cGMP manufacturing location for the company

Dupixent late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms

New late-breaking data showing additional improvements in disease severity and extent at the microscopic level

Decreases in Americans' Primary Care Visits May Lead to Late Diagnoses of Potentially Serious Conditions

The Bristol Myers Squibb–Pfizer Alliance, with the support of leading advocacy organizations and medical societies, announces the launch of the No Time to Wait campaign.

FDA authorises restart of the COVID-19 AZD1222 vaccine US Phase III trial

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world

Catalent launches OptiGel DR, a delayed/enteric release Softgel

The drug delivery innovation major launches Softgel for Pharmaceutical and Nutraceutical Applications

Lupin Wins Five INDIASTAR 2020 Awards for Excellence in Packaging

“Packaging is a key focus area for us and winning this award is a great honor as it demonstrates our level of commitment to excellence and design while keeping in mind quality, safety, and compliance requirements.”

Galera Therapeutics announces dosing of first patient for non-small cell lung cancer

Galera Therapeutics announces dosing of first patient in the phase 1/2 GRECO-1 clinical trial of GC4711 in combination with SBRT for non-small cell lung cancer

Zydus Cadila receives final approval from USFDA for Albuterol Tablets

Albuterol is a bronchodilator and it helps open up the airways in your lungs to make it easier to breathe.

Invitae corporation associates with Pacific Biosciences to develop whole genome sequencing for epilepsy

Invitae and Pacific Biosciences collaborate to develop whole genome sequencing-based assays for pediatric epilepsy diagnostics

Proteintech announced the acquisition of ChromoTek

The merger will enable the two companies to take full advantage of growing industry opportunities and more effectively address industry challenges

RedHill Biopharma collaborates with 2 pharma companies for manufacturing of COVID-19 vaccine

Opaganib demonstrated potent antiviral activity against SARS-CoV-2, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue.

Protagonist Therapeutics receives orphan drug designation from the EMA for PTG-300 in polycythemia vera

Protagonist Therapeutics has previously received orphan drug designation for the treatment of polycythemia vera from US FDA

Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Final Approval for Tavaborole Topical Solution

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Topical Solution, 5%, of Anacor Pharmaceuticals, Inc.

Merck Donates $500,000 to Support River Blindness and Lymphatic Filariasis Elimination Efforts

Merck and the MECTIZAN Donation Program, announced today a $500,000 cash donation to support NGO partners working to eliminate onchocerciasis and lymphatic filariasis

Samsung Biologics collaborates with Dinona for potential COVID-19 treatment

Under this agreement, Samsung and Dinona will collaborate for fast-track development of DNP-019, a potential COVID-19 antibody therapy

Valicare extends GxP expertise

A new focus is on consulting services for the transition of products from the development phase to the GMP compliant manufacturing of investigational medicinal products

Selecta Biosciences and Asklepios BioPharmaceutical receives US FDA approval for their gene therapy

Selecta Biosciences and AskBio receives US FDA rare pediatric disease designation for their gene therapy for methylmalonic acidemia

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine

GSK presents positive clinical data on maternal and older adults RSV candidate vaccines

Both candidate vaccines contain a recombinant subunit pre-fusion RSV antigen which is believed to trigger the required immune response

Alembic Pharmaceuticals announces USFDA Final Approval for Fenofibrate Capsules USP, 67 mg, 134 mg and 200 mg.

Fenofibrate Capsules USP, 67 mg, 134 mg and 200 mg have an estimated market size of US$ 17 million for twelve months ending June 2020 according to IQVIA.

No significant clinical benefit with Umifenovir addition in COVID-19 treatment: Glenmark clinical study

Umifenovir did not show superior clinical outcomes when added to Favipiravir treatment. The trial did not meet key end-points

Tyber Medical receives US FDA clearance on foot and ankle plating systems

The comprehensive portfolio is the first of several planned plating releases for the distal extremities

Zydus Cadila receives Final Approval from USFDA for Solifenacin Succinate Tablets

Zydus Cadila has received final approval from the USFDA to market Solifenacin Succinate Tablets, in the strengths of 5 mg and 10 mg

Astellas Pharma received US FDA approval for the treatment of primary mitochondrial myopathies

U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARδ modulator being developed for the treatment of primary mitochondrial myopathies

ViiV healthcare development program on cabotegravir and rilivirine has no pandemic interruptions

ViiV Healthcare, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

Cipla launches Nintib to treat Idiopathic Pulmonary Fibrosis, in continuation of its fight against rare lung diseases

Cipla Limited today announced that it has launched generic Nintedanib for the treatment of Idiopathic Pulmonary Fibrosis

IncellDx collaborates with Pfizer in a COVID-19 Phase 2 Clinical Trial

IncellDx to study Maraviroc, a CCR5 antagonist, in a COVID-19 phase 2 clinical trial

Dr. Reddy’s announces the re-launch of OTC Famotidine Tablets USP, store-brand equivalent of Pepcid AC in the U.S. Market

"We are pleased to continue to expand our OTC Antacid portfolio for our customers and consumers,” says Marc Kikuchi

Ezra receives US FDA clearance for prostate cancer artificial intelligence

Ezra's Prostate AI is the first to ever be cleared by the FDA for prostate and lesion segmentation using AI

AstraZeneca advances leadership in renal disease with more than 80 abstracts at ASN Kidney Week 2020 Reimagined

For roxadustat, more than 40 abstracts present safety and efficacy outcomes in anaemia of chronic kidney disease

AbbVie submits regulatory applications to US FDA and EMA for RINVOQ (upadacitinib) in atopic dermatitis

These submissions are an important step forward in the commitment to providing an additional treatment option

Orgenesis Inc announced completion of the acquisition of Koligo Therapeutics

Orgenesis Completes acquisition of Koligo Therapeutics and announces additional acquisition of Icellator technology from tissue genesis in related transaction

Aimmune Receives Positive CHMP opinion on PALFORZIA ; treatment of patients with peanut allergy

PALFORZIA recieves CHMP for Europe

Zydus Cadila receives tentative approval for Tofacitinib Extended-Release Tablets

Zydus Cadila has received tentative approval to market 11 mg Tofacitinib Extended-Release Tablets

Glenmark Pharmaceuticals receives ANDA approval for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg

Glenmark received approval from ANDA for Sirolimus Tablets, a generic version of Rapamune Tablets

Forxiga recommended for approval in the EU by CHMP for heart failure

If approved, Forxiga would become the first SGLT2 inhibitor indicated for heart failure with reduced ejection fraction in patients with and without type-2 diabetes

Regeneron’s Antibody cocktail REGN-EB3 (Inmazeb) is first FDA-Approved treatment for Ebola

First FDA approved antibody treatment for Ebola

Helix Technologies, Inc. and Medical Outcomes Research Analytics, LLC to Combine

Forian Inc. to Become Industry Leading Information, Analytics and Technology Provider for Healthcare and Cannabis Industries

Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials

Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD

Versantis AG received USFDA approval for VS-01 for the Treatment of Urea Cycle Disorders

Versantis receives US FDA rare pediatric disease designation for VS-01 for the treatment of urea cycle disorders

USFDA Accepts for Priority Review Applications for OPDIVO in Combination with CABOMETYX in Advanced Renal Cell Carcinoma

Results from CheckMate -9ER recently presented during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress

AbbVie received US FDA approval for the treatment of acute myeloid leukemia

Acute myeloid leukemia is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate

Fintepla of Zogenix received positive CHMP opinion for the treatment of dravet syndrome

Zogenix receives positive CHMP opinion for FINTEPLA (Fenfluramine) oral solution for the treatment of seizures in patients with dravet syndrome

Eli Lilly announces agreement to acquire Disarm Therapeutics

Eli Lilly successfully develop and commercialize new medicines resulting from the acquisition

ViiV Healthcare receives positive CHMP opinion for long-acting regimen for the treatment of HIV

ViiV Healthcare announced CHMP issed positive opinion recommending Vocabria in combination with Rekambys and Edurant for the treatment of HIV-1

CHMP recommends approval of Dupixent for children aged 6 to 11 years with severe atopic dermatitis

Dupixent combined with TCS in children aged 6 to 11 years with severe atopic dermatitis that is uncontrolled on topical prescription therapies

Merck received US FDA approval for Keytruda

FDA approves expanded indication for Merck’s KEYTRUDA (pembrolizumab) in adult patients with relapsed or refractory classical hodgkin lymphoma (cHL)

Roche intends to launch SARS-CoV-2 antigen test in suspected COVID-patients

These fully automated systems can provide test results in 18 minutes for a single test, excluding time for sample collection, transport, and preparation

Rentschler Biopharma collaborates with ATUM

Rentschler Biopharma and ATUM announce leap-In Transposase licensing agreement for development of robust manufacturing processes for complex therapeutic proteins

Celltrion Launches CT-P59, an antibody preventive treatment for COVID-19

Celltrion launches post-exposure prophylaxis clinical trial of anti-COVID-19 monoclonal antibody treatment candidate, CT-P59

Merck’s New VirusExpress Platform Speeds Development of Cell and Gene Therapies

Cell and gene therapies offer the potential for curative treatments and are being developed and commercialized in half the time it has taken traditional therapies

Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies

Sanofi and Translate Bio today announced the preclinical results of an mRNA-based vaccine candidate against SARS-CoV-2

FDA Approves Expanded Indication for Merck’s KEYTRUDA in Adult Patients With classical Hodgkin Lymphoma (cHL)

“With this approval, KEYTRUDA has the potential to change the current standard of care and help these patients achieve better outcomes.”

Glenmark introduces a generic version of NINDANIB for the treatment of Pulmonary Fibrosis

Glenmark being a leader in the area of respiratory has been amongst the first to launch the branded generic version for the treatment of Pulmonary Fibrosis in India.

WindMIL Therapeutics collaborates with Stephenson Cancer Center

WindMIL Therapeutics and Stephenson Cancer Center announce collaboration to collect bone marrow from patients with renal and urothelial carcinomas

Direct Biologics receives USFDA approval for ExoFlo in the treatment of COVID-19

US FDA's approval signifies a critical milestone in the development of advanced treatment for COVID-19 associated illnesses including ARDS

Novellus Therapeutics exclusively licenses induced mesenchymal stem cells (iMSCs) to NoveCite for COVID-19

Novellus Therapeutics exclusively licenses induced mesenchymal stem cells (iMSCs) to NoveCite for COVID-19 related acute respiratory distress syndrome (ARDS) and other acute respiratory conditions

Dupixent reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function

A pivotal Phase 3 trial of Dupixent met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma

Takeda accelerates digital transformation with Accenture and AWS

Collaboration will leverage cloud and data-driven insights to accelerate drug development, increase operational agility, reduce technology costs and develop the workforce of the future

Recipharm signs agreement with Arcturus Therapeutics for COVID-19 vaccine

Recipharm collaborates with Arcturus Therapeutics to support the manufacture of LUNAR -COV19 vaccine candidate

Abbott receives FDA emergency use authorization for its COVID-19 IgM antibody blood test

The new IgM antibody test is Abbott's latest test to support in the fight against COVID-19

Rhizen Pharmaceuticals S.A. and Curon Biopharmaceutical Limited Announce an Exclusive License Agreement to Develop and Commercialize Tenalisib

Rhizen and Curon's exclusive license agreement for Tenalisib, a dual PI3K delta & gamma inhibitor in the Greater China region.

Bristol Myers Squibb to acquire MyoKardia for $13.1 billion in cash

The acquisition of MyoKardia further strengthens Bristol Myers Squibb's portfolio, pipeline and scientific capabilities

AuraVax Therapeutics collaborates with University of Houston for intranasal COVID-19 vaccine

This novel intranasal vaccine technology, stop COVID-19, a respiratory virus, at its point of entry -- the nasal cavity

CartiHeal receives US FDA approval for its latest medical device

The device will provide a promising treatment for millions of patients who suffer from cartilage defects and currently lack good treatment options

Oxular receives US FDA approval for the treatment of eye cancer

Oxular receives rare paediatric disease and orphan-drug designations for retinoblastoma treatment

Rhizen Pharmaceuticals S.A. and Curon Biopharmaceutical Limited Announce an Exclusive License Agreement to Develop and Commercialize Tenalisib

Rhizen and Curon's exclusive license agreement for Tenalisib, a dual PI3K delta & gamma inhibitor in the Greater China region.

VirTrial collaborates with BetterLife to launch COVID-19 clinical trials

The partnership will enable BetterLife to conduct remote patient monitoring for their imminent COVID-19 clinical trials

Pfizer reports weekly Somatrogon is more effective in human growth deficiency

Clinical Study proves weekly administration of Somatrogon more effective in treating human growth deficiency disease

PENELOPE-B TRIAL OF IBRANCE (PALBOCICLIB) IN EARLY BREAST CANCER DID NOT MEET PRIMARY ENDPOINT

We are proud of the transformative impact IBRANCE has had on the treatment of HR+, HER2- metastatic breast cancer

Sobi announces topline phase 3 data of avatrombopag for the treatment of Chemotherapy

The international biopharmaceutical company firmly believe that avatrombopag could benefit patients with CIT

Innovent and Eli Lilly announce the NMPA granted marketing approval for HALPRYZA in China

The survival rate is also relatively higher than other tumour types when having appropriate treatment

COVID-19 AntiBody (LAAB) combination AZD7442 rapidly advances into Phase III clinical trials

The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

Tianda Pharmaceuticals acquires Yeung & Young Medicare and Qi's Living

The acquisition and cooperation represent an important step for the Group in the development of the entire TCM industrial chain

Johnson & Johnson receives approval from European Commission to provide 200 million doses of COVID-19 vaccine

This contract comes after the conclusion of exploratory talks with the European Commission

GSK's Dovato holds against Tenofavir Alafenamide Fumarate for HIV1 patients

GSK two drug combination is as good as 3 drug regimen which is presently continued for HIV 1 patients

COVID-19 AntiBody (LAAB) combination AZD7442 rapidly advances into Phase III clinical trials

The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

PENELOPE-B TRIAL OF IBRANCE (PALBOCICLIB) IN EARLY BREAST CANCER DID NOT MEET PRIMARY ENDPOINT

We are proud of the transformative impact IBRANCE has had on the treatment of HR+, HER2- metastatic breast cancer

Merck Announces Week 96 Data from Phase 2b Study Evaluating Islatravir With Doravirine for HIV-1

Merck, today announced Week 96 data from the Phase 2b trial evaluating the efficacy and safety of islatravir for HIV-1 infections

Zydus launches India’s first pressurized Metered Dose Inhaler for patients with Chronic Obstructive Pulmonary Disease

India’s first pressurized Metered Dose Inhaler for patients suffering from Chronic Obstructive Pulmonary Disease in India

Eisai associated with four research organizations in Japan for development of therapeutics for novel COVID-19

This collaborative research, aims to elucidate the mechanism of COVID-19 aggravation based on SARS-CoV-2 infection and to create drugs that prevent the aggravation of COVID-19.

Eton Pharmaceuticals submits new drug application to the FDA for Topiramate Oral Solution

Eton Pharma expects all three of the neurology product candidates to be approved and launched in 2021.

PFIZER AND SANGAMO DOSE FIRST PARTICIPANT IN PHASE 3 STUDY EVALUATING HEMOPHILIA

The initiation of the pivotal Phase 3 dosing study of giroctocogene fitelparvovec is a significant achievement for Pfizer as we continue our longstanding commitment to improving care for the hemophilia community

Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the U.S. FDA for Dimethyl Fumarate DR Capsules, the generic version of Tecfidera

Apollo Hospitals collaborates with HDFC Bank for quality healthcare

This collaboration will provide a holistic healthcare solution which makes healthy living accessible and affordable on Apollo’s digital platform, Apollo 24|7

Moleculin announces new antiviral drug candidates to treat HIV

Moleculin declares new antiviral drug candidates demonstrate in vitro activity against HIV. Also shows activity in Zika and Dengue Fever

Imbio collaborates with Genentech to develop imaging diagnostics for lung diseases

This collaboration has the potential to enhance drug development and deliver more personalized healthcare

BIONTECH AND PFIZER INITIATE ROLLING SUBMISSION TO EUROPEAN MEDICINES AGENCY FOR SARS-COV-2 VACCINE

Pfizer Inc. today announced the initiation of a rolling submission to the EMA for SARS-Cov-2 vaccine

Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study

Vir Biotechnology, Inc. and GlaxoSmithKline today announced the global expansion to Phase 3 of the COMET-ICE study for the early treatment of COVID-19 in patients.

Lupin Receives Approval for Dimethyl Fumarate Delayed-Release Capsules

After Dr Reddy's, Lupin Ltd. also launches Dimethyl Fumarate Delayed-Release Capsules

Neutral Atom launches UV disinfecting tower to fight COVID-19

Neutral Atom launches Spectra360 to fight against COVID-19: A UV disinfecting tower

Dr. Reddy’s Laboratories joins Science Based Targets initiative and sets 2030 GHG emission targets

Dr. Reddy’s Laboratories Ltd. has joined the SBTi becoming the first Indian and the third Asian pharma company to further minimize environmental impact

ViiV Healthcare announces dolutegravir plus lamivudine for treatment-naïve adults with HIV-1

Findings showed that the 2-drug regimen (2DR) of dolutegravir plus lamivudine continued to offer non-inferior efficacy

Zydus Healthcare launches highly affordable Dapagliflozin tablets in India for the treatment of Type 2 diabetes

Zydus Healthcare Limited announced that it is launching the anti-diabetic Dapagliflozin tablets in India upon its patent expiry under the brand name ‘Dapaglyn’

Novartis announces the safety and efficacy profile of Aimovig

Five-year open-label extension study shows patients continued to experience a sustained benefit; Aimovig maintained a consistent safety profile

Dr. Reddy's announces launch of a generic version of Sapropterin Dihydrochloride Tablets in the U.S. Market

Dr. Reddy’s Laboratories Ltd. today announced the launch of a generic version of Sapropterin Dihydrochloride Tablets, for Oral Use.

Sonovia Ltd. introduces SonoMask, can eliminate 99% of COVID particles

Lab results corroborate it effectively eliminate over 99% of COVID-19 particles.

Dr. Reddy's announces launch of a generic version of Sapropterin Dihydrochloride Tablets in the U.S. Market

Dr. Reddy’s Laboratories Ltd. today announced the launch of a generic version of Sapropterin Dihydrochloride Tablets, for Oral Use.

EMA accepts regulatory submission for avalglucosidase alfa for Pompe disease

Avalglucosidase alfa is an investigational enzyme replacement therapy, which, if approved, would offer a potential new standard of care for patients with Pompe disease

FibroGenesis Collaborates with R4D Biotech, expands fight against COVID-19 in Brazil

FibroGenesis signs cooperation agreement with R4D Biotech of São Paulo to advance the development of PneumoBlast cell therapy for the treatment of COVID-19

Thermaissance introduces reusable face mask, kills 99.99% coronavirus

Face masks and reusable PPE created using Thermaissance technology Is successfully inactivating coronavirus and pneumonia

PFIZER RECEIVES FDA FAST TRACK DESIGNATION FOR DUCHENNE MUSCULAR DYSTROPHY

Pfizer Inc. today announced that its investigational gene therapy candidate being developed to treat Duchenne muscular dystrophy

Relief Therapeutics signs an agreement with NeuroRx

NeuroRx and Relief Therapeutics establish supply and distribution agreements for RLF-100 (aviptadil)

IRISYS LLC announced its 3rd contract with TFF Pharma

IRISYS LLC signs the third contract with TFF Pharma to produce medication to treat lung conditions, including COVID-19

ABEC supporting Serum Institute of India in manufacturing COVID-19 vaccine

Serum Institute selects ABEC for large-scale, single-use COVID-19 vaccine manufacturing

Dr. Reddy's Laboratories announces the launch of Cinacalcet Tablets in the U.S. Market

Dr. Reddy’s Laboratories Ltd., today announced the launch of Cinacalcet Tablets, a generic version of Sensipar Tablets, approved by the USFDA

ViiV Healthcare to present long-term safety and efficacy data for 2-drug regimen

Data presented may shift the treatment paradigm to 2-drug regimens (2DRs) for people living with HIV

Lupin Launches Lapatinib Tablets

Lupin announced today the launch of Lapatinib Tablets, 250 mg, after Lupin’s alliance partner Natco Pharma Ltd received final approval for its ANDA from the USFDA

Lupin launches Lapatinib Tablets secures FDA approval

Lupin launches generic version of Novartis's Tykerb Tablets

Synthetic Biology introduces NanoSyrinx

Synthetic Biology start up NanoSyrinx secures capital to develop its fully customisable platform for intra-cellular engineering

Ajinomoto Bio-Pharma Services and DNDi Partner to develop Critical Immunomodulator

Partners will develop Critical Immunomodulator for Cutaneous Leishmaniasis Therapeutic

RDIF and Trinity Pharmaceuticals will provide COVID vaccine to Nepal

RDIF and Trinity Pharmaceuticals agree to supply 25 million doses of Sputnik V vaccine to Nepal

Moleculin Biotech discovered a molecule, displayed significant in vitro antiviral activity against SARS-CoV-2

The pharma co. anticipates it will take at least twelve months of development work to assess clinical potential for these new molecules

Sanofi completes Principia Biopharma Inc. acquisition

Sanofi announced today the successful completion of its acquisition of Principia Biopharma Inc. for $100 per share in cash.

Merck Animal Health Supports Rabies Elimination by 2030 on World Rabies Day

Merck Animal Health announced the launch of a global campaign to raise awareness among veterinarians, dog owners and volunteers who are committed to eliminate rabies through ongoing dog vaccination efforts.

Health Minister Dr Harsh Vardhan launches ICMR's vaccine web portal & National Clinical Registry

National Clinical Registry for Covid-19 launched by Dr Harsha Vardhan

Lupin launches Atorvastatin Calcium Tablets USP for cholesterol treatment

The tablet already got USFDA clearance earlier

U.S. FDA APPROVES PFIZER’S XELJANZ FOR THE TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS

Pfizer Inc. announced XELJANZ (tofacitinib) for the treatment of children 2 years and older with active polyarticular course juvenile idiopathic arthritis

Lupin Launches Fosaprepitant for injection ; emetogenic cancer chemotherapy

150 mg Single-Dose Vial, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier.

Applied Therapeutics receives USFDA approval for treatment of PMM2-CDG

US FDA grants AT-007 pediatric rare disease designation and orphan designation for treatment of PMM2-CDG

AliveCor introduces US FDA cleared personal ECG technology in India

India’s heart care gets a big boost with world’s most clinically validated personal ECG device

Cipla receives final approval for generic version of Biogen IDEC Inc.’s Tecfidera

Cipla Limited today announced that it has received final approval for its ANDA for Dimethyl Fumarate Capsules

FDA approves Nucala as the first and only biologic treatment for Hypereosinophilic Syndrome

Third US indication for Nucala demonstrates GSK’s commitment to finding new ways to help patients with eosinophil-driven diseases

Zydus Cadila receives final approval for Dimethyl Fumarate Capsules

Dimethyl Fumarate Capsules are indicated for the treatment of multiple sclerosis

Dr. Reddy's announces launch of Dexmedetomidine Hydrochloride in the U.S. Market

“Our ability to adequately supply Dexmedetomidine is important for patients as it is on the FDA’s Drug Shortage list.”

Dr. Reddy's anti viral drug Avigan produced promising result in treating COVID-19 patients in Japan

Completed phase 3 clinical study paves way for approval request

Zydus Cadila receives tentative approval from USFDA for Palbociclib Capsules

Zydus Cadila has received tentative approval from the USFDA to market Palbociclib Capsules, an anti-cancer medicine

Panacea Biotec successfully completes phase I/II study for dengue vaccine

DengiAll has been found to be safe and well-tolerated with no serious adverse effects

Genocea announces FDA acceptance of GEN-011 IND Application

Investigational drug status for Genocea T cell therapy drug

Mylan collaborates with CSIR for management of COVID-19

A series of clinical trials will be conducted towards new and innovative solutions to manage COVID-19 pandemic in India as part of this collaboration

Today, Phase-3 clinical trial of Oxford Coronavirus vaccine to begin at KEM hospital Mumbai

Halted AstraZeneca/Oxford University vaccine resumes trial

Sanofi and GSK sign agreements with Canadian Govt. to supply up to 72 million doses of COVID vaccine

Agreements relate to vaccine candidate using Sanofi’s recombinant protein-based technology and GSK’s pandemic adjuvant.

Oxford Nanopore Technologies sign Non-Exclusive licensing agreement Genetics Research

Oxford Nanopore Technologies Sign Non-Exclusive Licensing Agreement for Genetics Research’s Patented DNA Negative Enrichment Technology Platform

Sun Pharma Announces the Launch of ILUMYA for Treatment of Plaque Psoriasis in Japan

Sun Pharma today announced that its wholly-owned Japanese subsidiary has launched ILUMYA Subcutaneous Injection 100 mg Syringe

CHMP recommends approval of Supemtek for the prevention of influenza in adults aged 18 and above

CHMP has adopted a positive opinion for Supemtek for active immunization for the prevention of influenza in adults

Johnson & Johnson initiates phase 3 clinical trial for COVID-19 vaccine Candidate

The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use

Gyroscope Therapeutics Granted FDA Fast Track Designation for GT005

Investigational Gene Therapy for dry, age-related Macular Degeneration

FDA ACCEPTS SUPPLEMENTAL NEW DRUG APPLICATION FOR PFIZER’S XALKORI

Pfizer Inc. today announced that the U.S. FDA has accepted and granted priority review to the Company’s supplemental New Drug Application for XALKORI

Bristol Myers Squibb Completes Acquisition of Forbius

Latest Pharma acquisation news Sep 23, 2020

PharmAbcine entered into a strategic partnership with Samsung Biologic

PharmAbcine is a clinical-stage biotech company developing fully human therapeutic antibodies to treat cancer and neovascular disease

City of Hope collaborates with Chimeric to develop cell therapy

City of Hope enters licensing agreement with Chimeric Therapeutics Limited to develop its pioneering chlorotoxin CAR T Cell therapy

Lupin Launches Divalproex Sodium ER Tablets USP

Pharma major Lupin Limited announced the launch of Divalproex Sodium Extended-Release (ER) Tablets USP, 250 mg and 500 mg, after an approval by U.S. FDA.

Citius Pharma announces, achieved significant milestones for Mino-Lok

Citius Pharmaceuticals achieves chemical manufacturing and control milestones for Mino-Lok

Preparation products of Yiling Pharma approved by FDA for launch in the US market

Receives ANDA for Lisinopril and Acylovir tablets

DuPont Human Microbiome Venture and Procter & Gamble research collaboration for Probiotics

Probiotics holds the key for efficient gut management

Late-breaking ESMO presentation shows Libtayo® (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1

Positive pivotal trial data for the investigational use of PD-1 inhibitor Libtayo® (cemiplimab) in first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) were shared in a presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Sanofi and GSK partners for supplying 300 million doses of COVID-19 vaccine to EU countries

Sanofi and GSK finalised and signed today an advanced purchase agreement with the European Commission (EC) for supplying their vaccine