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1014 News Found

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


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


Merck and AstraZeneca present final results from Phase 3 PROpel Trial
Drug Approval | February 18, 2023

Merck and AstraZeneca present final results from Phase 3 PROpel Trial

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival


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


Biocon Q3 FY23 revenue up 36%
News | February 17, 2023

Biocon Q3 FY23 revenue up 36%

The company's consolidated revenues for the quarter grew 36% to Rs. 3,020 crore on the back of robust performance across all its three businesses


Thermo Fisher Scientific to introduce fully automated cell line automation platform
Medical Device | February 14, 2023

Thermo Fisher Scientific to introduce fully automated cell line automation platform

Thermo Fisher and Celltrio bring first-in-kind automation platform to address critical scale-up challenges in biotherapeutics RoboCell cell line automation platform


Glenmark Pharma reports Q3 FY 2022-23 revenue growth of 9.2%; PAT growth of 21.3%
News | February 11, 2023

Glenmark Pharma reports Q3 FY 2022-23 revenue growth of 9.2%; PAT growth of 21.3%

Profit After Tax (PAT) for the quarter ended December 31, 2022 was at Rs. 290.8 crore as compared to Rs. 239.8 crore in the previous corresponding quarter, registering a growth of 21.3% YoY


Lupin receives approval from USFDA for Glycopyrrolate Injection USP
News | February 10, 2023

Lupin receives approval from USFDA for Glycopyrrolate Injection USP

The approval for Glycopyrrolate clears the path for more internally manufactured injectable products


Lupin Q2 FY23 revenue up 3.9%; Profit down 71%
News | February 10, 2023

Lupin Q2 FY23 revenue up 3.9%; Profit down 71%

With the recent sales force expansion and new product launches, we expect to be back to above-market growth