Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 161

Results For "regulator"

1840 News Found

Torrent Pharma to launch molnupiravir under the brand name Molnutor in India
Drug Approval | December 28, 2021

Torrent Pharma to launch molnupiravir under the brand name Molnutor in India

DCGI approved the drug based on the review of clinical data


Dr Reddy’s receives Emergency Use Authorisation for molnupiravir
Drug Approval | December 28, 2021

Dr Reddy’s receives Emergency Use Authorisation for molnupiravir

The company will market it under the brand name Molflu


Aurobindo to manufacture and market molnupiravir
Drug Approval | December 28, 2021

Aurobindo to manufacture and market molnupiravir

The drug will be marketed under the brand name Molnaflu


Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution
Medical Device | December 27, 2021

Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution

The Covid-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron


NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


WHO grants EUL for Covovax
Drug Approval | December 20, 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine


Merck’s tepmetko receives positive CHMP opinion in Europe
Biotech | December 20, 2021

Merck’s tepmetko receives positive CHMP opinion in Europe

The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


Cipla acquires stake in Clean Max Auriga Power
Sustainability | December 16, 2021

Cipla acquires stake in Clean Max Auriga Power

Clean Max Auriga Power is a special purpose vehicle engaged in the business of production, supply and distribution of solar and wind or other renewable energy generation plant


Immatics and Bristol Myers Squibb enter exclusive license for TCR Bispecific programme
Biotech | December 15, 2021

Immatics and Bristol Myers Squibb enter exclusive license for TCR Bispecific programme

Immatics to receive upfront payment of US $ 150 million and additional milestone payments of up to US $ 770 million plus tiered double-digit royalties on net product sales