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Results For "biologics"

475 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


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


China aims to lead next bio revolution in advanced biologics, says GlobalData
News | December 15, 2022

China aims to lead next bio revolution in advanced biologics, says GlobalData

China is now focusing on establishing volume and enhancing capabilities for innovative high value drug production


LG Chem inks deal with Innovent Biologics for gout treatment candidate
News | December 15, 2022

LG Chem inks deal with Innovent Biologics for gout treatment candidate

LG Chem will receive totaling up to $95.5 million for the China rights


Biocon Biologics elevates Shreehas Tambe as MD & CEO
People | December 06, 2022

Biocon Biologics elevates Shreehas Tambe as MD & CEO

Tambe has been with Biocon since 1997 and has held diverse leadership and operational roles.


Biocon Biologics completes acquisition of Viatris' Global Biosimilars Business
News | November 30, 2022

Biocon Biologics completes acquisition of Viatris' Global Biosimilars Business

To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan


Biocon Biologics features on ASIA IP ELITE List 2022
News | November 14, 2022

Biocon Biologics features on ASIA IP ELITE List 2022

This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


Biocon Biologics signs licensing agreement with Yoshindo
News | October 17, 2022

Biocon Biologics signs licensing agreement with Yoshindo

Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics