Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 149

Results For "regulatory"

1624 News Found

EMA encourages companies to submit type I variations by end- November
Policy | November 01, 2021

EMA encourages companies to submit type I variations by end- November

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021


Takeda to acquire GammaDelta Therapeutics
Biotech | October 29, 2021

Takeda to acquire GammaDelta Therapeutics

The acquisition expands Takeda’s immuno-oncology and innate immune cell therapy portfolio with novel platforms leveraging T cells for the potential treatment of solid tumours and haematological malignancies


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.


Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


WHO selects Medigen’s Covid-19 vaccine for solidarity trial
Biotech | October 27, 2021

WHO selects Medigen’s Covid-19 vaccine for solidarity trial

Following the review of around 20 candidate vaccines by the external advisory group, MVC's vaccine was selected as one of two to be included in the global trial


Novavax files for approval of its Covid-19 vaccine in the UK
Biotech | October 27, 2021

Novavax files for approval of its Covid-19 vaccine in the UK

Filing marks first protein-based vaccine submitted to MHRA for authorization


Biocon reports a consolidated net profit of Rs. 138.3 crore in Q2FY22
News | October 25, 2021

Biocon reports a consolidated net profit of Rs. 138.3 crore in Q2FY22

The Research Services and Biosimilars business segments reported a growth of 17% and 10%, respectively


U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option


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


Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts
News | October 21, 2021

Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts

Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)