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Merck and Ridgeback’s molnupiravir offer hope to Covid-19 patients
Biotech | October 01, 2021

Merck and Ridgeback’s molnupiravir offer hope to Covid-19 patients

If cleared, Merck's drug would be the first pill shown to treat Covid-19, a potentially major advance in efforts to fight the pandemic


U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


Novavax and Serum seek WHO approval for Covid-19 vaccine
News | September 24, 2021

Novavax and Serum seek WHO approval for Covid-19 vaccine

It is a recombinant nanoparticle protein-based vaccine


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year


Novartis’ Kisqali data indicates longest median survival in advanced breast cancer
Drug Approval | September 20, 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


Apollo Hospital Chennai completes India’s first robotic bariatric surgery
Hospitals | September 18, 2021

Apollo Hospital Chennai completes India’s first robotic bariatric surgery

This procedure is incidentally the first robotic bariatric surgery in the world to be performed in just three ports


Canada approves Moderna’s Covid-19 vaccine
Drug Approval | September 17, 2021

Canada approves Moderna’s Covid-19 vaccine

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose


US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Drug Approval | September 12, 2021

US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma

Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma


New law to regulate drugs  and medical devices soon
Policy | September 09, 2021

New law to regulate drugs and medical devices soon

The panel is headed by DCGI Dr VG Somani with representatives from various state drug regulators and health ministry