Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 124

Results For "regulator"

1846 News Found

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


Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis
Clinical Trials | October 13, 2022

Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis

68% of children on a higher dose of Dupixent achieved histological disease remission at week 16


M. Holland join hands with LyondellBasell to distribute purell medical grade resins
Supply Chain | October 13, 2022

M. Holland join hands with LyondellBasell to distribute purell medical grade resins

New material distribution will serve medical device and pharmaceutical packaging manufacturers.


Merck announces positive top-line results from Phase 3 Stellar Trail evaluating Sotatercept for the treatment of PAH
Clinical Trials | October 11, 2022

Merck announces positive top-line results from Phase 3 Stellar Trail evaluating Sotatercept for the treatment of PAH

Sotatercept demonstrated significant improvement in exercise capacity and key secondary outcome measures compared to placebo when added to background therapy


Pfizer announces positive topline results from Phase 3 TALAPRO-2 trial
Clinical Trials | October 09, 2022

Pfizer announces positive topline results from Phase 3 TALAPRO-2 trial

Study achieves primary endpoint of radiographic progression-free survival


Glenmark launches Lobeglitazone in India for Uncontrolled Type 2 Diabetes in adults
News | October 07, 2022

Glenmark launches Lobeglitazone in India for Uncontrolled Type 2 Diabetes in adults

Glenmark is the first company in India to launch Thiazolidinedione Lobeglitazone (0.5 mg).