Strides flagship facility in Bangalore receives USFDA inspection closure

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma

No link between the use of ranitidine and cancer risk, claims Nature

N-nitroso dimethylamine (NDMA) is a probable human carcinogen and tts effects on humans rely on observational studies.

Novartis appoints Gilbert Ghostine Chairman-Designate of Sandoz Board of Directors

Ghostine has served as CEO of Geneva-based Firmenich, the world's largest privately owned perfume and taste company, since 2014.

MEI Pharma and Infinity Pharmaceuticals inks merger agreement to advance three promising clinical oncology candidates

Projected ~US$100 million cash balance of combined company expected to fund operations through mid-2025 and to clinical data over the next 12 to 24 months

Thyrocare adopts SigTuple’s AI100 to make quality diagnostics accessible

In a bid to better leverage its clinical expertise and drive quality reporting across its centres, Thyrocare has added SigTuple’s AI100 to automate the microscopic review in its laboratories

Genomics, big data among key themes driving M&A activity in medical devices, says GlobalData

A total of 889 M&A deals were announced in the medical devices sector in 2022 worth $93 billion

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency

Bluestem Biosciences files 24 patent applications

At commercial scale, Bluestem's patent pending technologies will reduce carbon emission by an estimated 75% or more and be cost-competitive with petroleum based chemicals