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2985 News Found

NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


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


Moderna says Covid-19 booster dose works against Omicron in lab study
News | December 20, 2021

Moderna says Covid-19 booster dose works against Omicron in lab study

Authorized booster increases Omicron neutralizing antibody levels approximately 37-fold


Novel Concepts Medical’s formula disrupts Covid-19 spike protein
Biotech | December 17, 2021

Novel Concepts Medical’s formula disrupts Covid-19 spike protein

The company is now ready to offer clinical testing anywhere in the world after early case studies conducted in Israel have demonstrated recovery within 48 hours


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


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


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


U.S. FDA approves Bristol Myers Squibb’s Orencia
Drug Approval | December 16, 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant


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