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3695 News Found

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


Piramal Pharma starts production at new API facility in Riverview, Michigan
News | February 20, 2023

Piramal Pharma starts production at new API facility in Riverview, Michigan

New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)


Fluor selected by Agilent for expansion of oligonucleotide manufacturing facility in Colorado
News | February 19, 2023

Fluor selected by Agilent for expansion of oligonucleotide manufacturing facility in Colorado

Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability


Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Drug Approval | February 18, 2023

Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million


Lupin receives EIR from USFDA for injectable facility in Nagpur
News | February 18, 2023

Lupin receives EIR from USFDA for injectable facility in Nagpur

The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022


Lonza completes expansion of conjugation facility in Visp
News | February 17, 2023

Lonza completes expansion of conjugation facility in Visp

The investment enhances Lonza’s capabilities and flexibility to support both clinical and commercial supply and will play a key role in meeting the growing market demand for bioconjugates