Sunday, September 19, 2021
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Roche receives approval for laboratory based Elecsys SARS-CoV-2 antigen test

The Elecsys SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of active SARS-CoV-2 infection....................

Roche gets DCGI nod for its investigational antibody cocktail in India

Casirivimab and Imdevimab is indicated for the treatment of mild to moderate Covid-19 in high-risk patients........................

Mankind Pharma seeks CDSCO’s nod to conduct phase-1 clinical trials of...

A patented first in class novel anti-diabetic molecule, MKP10241 is a potent and orally administered small molecule, GPR119 agonist.........................

Advancements in digital technology critical to clinical trials: Experts

Across the pharmacovigilance, biostatistics, medical writing and clinical data management sessions, panelists spoke of the digital-enabled regulatory flexibility during the pandemic........................

Wait over as DCGI approves Bharat Biotech & Serum Institute COVID-19...

After adequate examination, Central Drugs Standard Control Organisation decided to accept the recommendations of the Expert Committee, and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in an emergency situation

Zydus seeks approval to commence Phase III clinical trials of its...

New Delhi: Zydus Cadila has announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe, well tolerated and immunogenic in...

India taking baby steps to harmonize international regulatory standards for medical...

As per Dr V G Somani, Drugs Controller General of India, the medical device industry needs to look at quality, affordability, and access, and service delivery while developing products from a pricing and regulatory perspective..........................

MTaI welcomes CDSCO’s latest move to boost ease of doing business...

Medical Technology Association of India has welcomed two latest notices from the Central Drugs Standard Control Organization (CDSCO) that address operational and regulatory challenges faced by the medical device industry...........

DCGI nod to Serum Institute for conducting human trials of Oxford...

The Drugs Controller General of India has given the Serum Institute of India a green light to conduct phase 2 and 3 human trials of the Oxford-AstraZeneca COVID-19 vaccine candidate in India..................

Baxter India gets CDSCO nod for Oxiris Filter to treat COVID-19...

Oxiris Blood Purification Filter is intended for use in critically ill COVID-19 patients in need of Blood Purification where excessive Inflammatory Mediators are present i.e. Cytokine Storm release.........................