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7043 News Found

U.S. FDA approves ANI’s purified cortrophin gel
Biotech | November 03, 2021

U.S. FDA approves ANI’s purified cortrophin gel

Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016


WHO issues emergency use listing for Covaxin
News | November 03, 2021

WHO issues emergency use listing for Covaxin

This is the eighth Covid-19 vaccine to receive Emergency Use Listing


SOPHiA Genetics launches SOPHiA DDM to assist Agilent customers
Digitisation | November 02, 2021

SOPHiA Genetics launches SOPHiA DDM to assist Agilent customers

New bioinformatic workflow advances analysis capabilities for whole-exome assessment and interpretation


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


Boehringer Ingelheim announces EMA marketing authorisation for spesolimab
Drug Approval | October 29, 2021

Boehringer Ingelheim announces EMA marketing authorisation for spesolimab

Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules


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


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


NPPA fixes ceiling price for anti-diabetic generic medicines
Policy | October 26, 2021

NPPA fixes ceiling price for anti-diabetic generic medicines

A total of 12 generic medicines have been included in the list


GenWorks Heath to distribute PerkinElmer’s newborn and prenatal screening products
Medical Device | October 26, 2021

GenWorks Heath to distribute PerkinElmer’s newborn and prenatal screening products

Collaboration designed to bring reproductive health screening capabilities to hospitals and clinics across the country


10x Genomics opens Singapore manufacturing hub
Biotech | October 26, 2021

10x Genomics opens Singapore manufacturing hub

Strengthens supply chain continuity with first manufacturing facility outside of the U.S.