Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 67

Results For "regulatory"

1225 News Found

Balaxi Pharmaceuticals delivers strong growth in Q2 FY23
News | November 07, 2022

Balaxi Pharmaceuticals delivers strong growth in Q2 FY23

Revenue is up 23% whereas Profit After Tax expands 29% for the company


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan


Lonza launches new capsule to deliver acid-sensitive API to the intestine
News | November 02, 2022

Lonza launches new capsule to deliver acid-sensitive API to the intestine

Innovative Capsugel Enprotect capsule can simplify the manufacturing process to accelerate drug development and expedite first-in-human timelines


Piramal Enterprises appoints Gautam Doshi as Additional Director
People | November 01, 2022

Piramal Enterprises appoints Gautam Doshi as Additional Director

His experience covers a wide range of areas including advisory services in the field of accounting, taxation, corporate and commercial laws, and regulatory matters


USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility
News | October 31, 2022

USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility

The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue


Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


Quizartinib granted priority review in the U.S.
Drug Approval | October 26, 2022

Quizartinib granted priority review in the U.S.

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone


USFDA approves Imjudo in combination with Imfinzi for liver cancer
Drug Approval | October 26, 2022

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib


Syngene Q2 FY23 PAT up 11% to Rs. 102 Cr
News | October 20, 2022

Syngene Q2 FY23 PAT up 11% to Rs. 102 Cr

Revenue from operations up 26% to Rs. 768 crores


Cytel to acquire SDS Life Science and SDS MedteQ
News | October 14, 2022

Cytel to acquire SDS Life Science and SDS MedteQ

The move will add new global talent to Cytel’s Strategic Consulting group