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300 News Found

Jemperli RUBY phase III trial met its primary endpoint
Clinical Trials | December 05, 2022

Jemperli RUBY phase III trial met its primary endpoint

Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival


Briefs: Piramal Enterprises and Shilpa Medicare
News | December 02, 2022

Briefs: Piramal Enterprises and Shilpa Medicare

Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval


Sai Life Sciences appoints Stephen Hermitage as VP, CMC
People | November 28, 2022

Sai Life Sciences appoints Stephen Hermitage as VP, CMC

Steve joins Sai Life Sciences from GlaxoSmithKline (GSK) where he was a department head and member of the global chemical development leadership team.


Chantal van Gils joins NDA Advisory Board as Director of Epidemiology
People | November 27, 2022

Chantal van Gils joins NDA Advisory Board as Director of Epidemiology

She will provide strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy


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


Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program
Drug Approval | November 01, 2022

Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.


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


Piramal Pharma Solutions launches ADCelerate
News | October 13, 2022

Piramal Pharma Solutions launches ADCelerate

ADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submission


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses