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1091 News Found

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


U.S. FDA approves first and only injectable option for HIV prevention
Drug Approval | December 21, 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition


Merck’s tepmetko receives positive CHMP opinion in Europe
Biotech | December 20, 2021

Merck’s tepmetko receives positive CHMP opinion in Europe

The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease


Alloy Therapeutics acquires deepCDR Biologics to bring ML into drug discovery
Digitisation | December 17, 2021

Alloy Therapeutics acquires deepCDR Biologics to bring ML into drug discovery

The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles


Noorik Biopharma signs contract with Switzerland to develop ambrisentan to treat severe Covid-19
Biotech | December 16, 2021

Noorik Biopharma signs contract with Switzerland to develop ambrisentan to treat severe Covid-19

The primary objective of the ongoing trial is to determine whether ambrisentan can prevent the progression to respiratory failure and reduce the need for mechanical ventilation, among others


Syngene extends contract with Amgen till 2026
News | December 16, 2021

Syngene extends contract with Amgen till 2026

Syngene will also build and operate a new dedicated drug development laboratory to accelerate the advancement of Amgen R&D projects


USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria
Biotech | December 16, 2021

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria

ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains


Aragen Life Sciences acquires Intox
Biotech | December 15, 2021

Aragen Life Sciences acquires Intox

Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune