Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 156

Results For "regulator"

1841 News Found

Covaxin and Covishield granted conditional market approval
News | January 27, 2022

Covaxin and Covishield granted conditional market approval

The vaccines are currently only authorised for emergency use in the country


Botanical Solution Inc. raises $6.1 million in Series A
Startup | January 27, 2022

Botanical Solution Inc. raises $6.1 million in Series A

The company develops sustainable botanical materials for agricultural and pharmaceutical applications


Philips introduces at-home, 12-lead ECG integrated solution for trials
Medical Device | January 26, 2022

Philips introduces at-home, 12-lead ECG integrated solution for trials

Philips expands remote cardiac monitoring portfolio with patch-based, clinical-grade ECG designed to improve patient recruitment, compliance and retention by reducing need for site visits during clinical trials


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


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