Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 178

Results For "regulator"

2057 News Found

Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation
News | January 25, 2022

Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation

The company has been manufacturing masks since the Covid-19 outbreak in 2020


Sanofi signs as first partner of Protas
Biotech | January 25, 2022

Sanofi signs as first partner of Protas

The collaboration with Sanofi signifies a considerable investment in the UK’s Life Sciences sector and, along with other future strategic partners, has the potential to increase the pipeline of potential treatment options for a wide range of common and other life-threatening diseases


Eplontersen granted Orphan Drug Designation in the US
Biotech | January 24, 2022

Eplontersen granted Orphan Drug Designation in the US

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US


Positive top-line results for bimekizumab in second phase 3 psoriatic arthritis study
Biotech | January 22, 2022

Positive top-line results for bimekizumab in second phase 3 psoriatic arthritis study

UCB plans to submit regulatory applications in Q3 2022


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


Medicines Patent Pool finalises 27 generic manufacturers to produce molnupiravir
Drug Approval | January 21, 2022

Medicines Patent Pool finalises 27 generic manufacturers to produce molnupiravir

The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list


Glenmark Specialty S.A. partners with Lotus to commercialise Ryaltris in key Asian markets
News | January 20, 2022

Glenmark Specialty S.A. partners with Lotus to commercialise Ryaltris in key Asian markets

The company will receive an upfront payment as well as regulatory and sales based milestone payments from Lotus


SEC recommends regular market approval for Covishield and Covaxin
News | January 20, 2022

SEC recommends regular market approval for Covishield and Covaxin

However, these won’t be available at the nearest chemist store soon


Lonza, Forbion, and BioGeneration to focus on manufacturing of small molecules
News | January 19, 2022

Lonza, Forbion, and BioGeneration to focus on manufacturing of small molecules

The extended collaboration will provide services relating to small molecules for both Forbion and BGV portfolio companies active in the biopharmaceutical space