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Results For "European-Union"

214 News Found

Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate
Clinical Trials | July 28, 2022

Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate

This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.


Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine
News | June 30, 2022

Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine

105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses


Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer
Drug Approval | June 28, 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients


Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron
News | June 27, 2022

Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron

Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine


Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer
Drug Approval | June 24, 2022

Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer

Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally


AstraZeneca and Merck announces results from phase 3 PROpel trial of Lynparza
News | June 22, 2022

AstraZeneca and Merck announces results from phase 3 PROpel trial of Lynparza

LYNPARZA is approved in the U.S. for patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations)


Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation
News | June 18, 2022

Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation

Both manufacturing facilities are based out of Benguluru, India


Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation
Drug Approval | June 16, 2022

Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation

Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation


Takeda’s dengue vaccine candidate offers protection against dengue fever in clinical trial
Clinical Trials | June 11, 2022

Takeda’s dengue vaccine candidate offers protection against dengue fever in clinical trial

TAK-003 is currently undergoing regulatory review for potential licensure in both the European Union


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