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Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

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
Drug Approval | February 25, 2023

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
News | February 24, 2023

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.


SERDA therapeutics submits IND for wound debridement agent
Drug Approval | February 24, 2023

SERDA therapeutics submits IND for wound debridement agent

Clinical studies are expected to start in Q2 2023.


Aji Bio-Pharma develops highly functional ancestral RNA ligase
Biotech | February 23, 2023

Aji Bio-Pharma develops highly functional ancestral RNA ligase

This artificial RNA ligase has higher thermostability than natural RNA ligase


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

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


Thyrocare adopts SigTuple’s AI100 to make quality diagnostics accessible
Digitisation | February 22, 2023

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
News | February 22, 2023

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


Bluestem Biosciences files 24 patent applications
News | February 21, 2023

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


Dalton ramp ups sterile manufacturing capacity
News | February 20, 2023

Dalton ramp ups sterile manufacturing capacity

The new sterile filling line meets cGMP aseptic filling regulatory requirements