Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 10

Results For "European-Commission"

123 News Found

USFDA approves Novartis Kymriah CAR-T cell therapy
Biotech | May 29, 2022

USFDA approves Novartis Kymriah CAR-T cell therapy

68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile


Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe
News | May 21, 2022

Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe

The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022


Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe
Biotech | May 10, 2022

Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe

Myovant to receive an upfront payment of US $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to US $90.5 million


NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency
Biotech | April 23, 2022

NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency

Heavy bleeding after giving birth is globally a leading cause of death in new mothers


CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment
Drug Approval | April 23, 2022

CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment

If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe


CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer
Biotech | April 23, 2022

CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer

With one of the most diverse lung cancer development programs, Novartis is focused on investments to advance the science, drive treatment and make an impact on patients


Albumedix and Valneva expand collaboration to include newly approved inactivated Covid-19 vaccine
Biotech | April 18, 2022

Albumedix and Valneva expand collaboration to include newly approved inactivated Covid-19 vaccine

This marks an expansion of the companies' existing collaboration and further validates the use of Albumedix Recombumin rHA products in the manufacturing process and final formulation of critical vaccines


Alvotech and STADA pave way to launching Hukyndra
Biotech | April 06, 2022

Alvotech and STADA pave way to launching Hukyndra

All intellectual-property disputes related to the market entry of Alvotech’s AVT02 (adalimumab) in the U.S. and Europe are now resolved


Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product


Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors
Drug Approval | March 30, 2022

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding