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MSD and MPP sign licensing agreement to make molnupiravir affordable
Biotech | October 28, 2021

MSD and MPP sign licensing agreement to make molnupiravir affordable

In India, MSD has signed non-exclusive licensing agreements with eight pharma companies.


Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
Biotech | October 28, 2021

Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population


Zydus announces update on a randomised trial of Saroglitazar Mg in NASH
Biotech | October 22, 2021

Zydus announces update on a randomised trial of Saroglitazar Mg in NASH

Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Vertex’s stem cell therapy for Type 1 diabetes reduced daily insulin requirement by 91 %
Biotech | October 19, 2021

Vertex’s stem cell therapy for Type 1 diabetes reduced daily insulin requirement by 91 %

The first patient dosed with VX-880 demonstrated restoration of insulin production and achieved C-peptide of 560 pmol/L in response to Mixed Meal Tolerance Test (MMTT) at Day 90 visit


Ipsen enters exclusive worldwide tie-up with Accent for its pre-clinical R&D oncology pipeline
Biotech | October 18, 2021

Ipsen enters exclusive worldwide tie-up with Accent for its pre-clinical R&D oncology pipeline

Ipsen obtains an exclusive license to develop, manufacture and commercialize a pre-clinical stage METTL3-inhibitor programme


Exelixis in-licenses second anti-cancer compound from Aurigene
Biotech | October 15, 2021

Exelixis in-licenses second anti-cancer compound from Aurigene

U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma


Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir
News | October 11, 2021

Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir

If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19


Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation
Biotech | October 09, 2021

Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022


Sanofi says positive results from flu vaccine with mRNA booster study
Biotech | October 08, 2021

Sanofi says positive results from flu vaccine with mRNA booster study

The first study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older