The UK government has signed its fourth coronavirus vaccine deal, snapping up 60 million doses of an experimental shot being developed by Sanofi and GlaxoSmithKline. The order has come in even before the vaccine has started clinical development, with a…
Setback in COVID-19 effort as Roche’s Actemra fails in key trial
Roche’s anti-inflammatory drug Actemra has failed in a phase 3 clinical trial that was testing to see if it improved the condition of patients with COVID-19 associated pneumonia. The COVACTA trial of Actemra (tocilizumab) did not meet its primary endpoint…
Govt Releases Guidelines For Schemes To Boost Domestic Manufacturing Of Bulk Drugs, Med Devices
The government on Monday released guidelines of four schemes for the development of bulk drug and medical device parks across the country to promote their domestic manufacturing. These schemes of the Department of Pharmaceuticals were approved by the Union Cabinet…
CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma
GlaxoSmithKline is closing in on EU approval for its first-in-class BCMA-targeting drug Blenrep, after getting a green light from the EMA’s human medicines committee. Blenrep, based on the antibody-drug conjugate belantamab mafodotin, has been recommended for conditional approval by the…
UCB’s IL-17 latecomer bimekizumab beats Cosentyx in psoriasis trial
Belgian biopharma company UCB is bringing up the rear of the IL-17 inhibitor category with its bimekizumab drug, so is celebrating new late-stage data showing superiority to the class leader. The BE RADIANT trial pitted bimekizumab against Novartis’ Cosentyx (secukinumab)…
AstraZeneca inks $6bn cancer drug deal with Daiichi Sankyo
AstraZeneca has begun a new agreement with Daiichi Sankyo to develop and market an antibody to treat cancer, worth up to $6 billion. The deal covers DS-1062, Daiichi Sankyo’s proprietary antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (TROP2). AZ and…
Moderna gets further $472m as expanded phase 3 COVID-19 trial begins
A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab. The latest funding from the Biomedical Advanced Research and Development Authority…
Bengaluru Organisation Gets US FDA, EU Approval For Medical Device That Can Neutralise Coronavirus
The device – named Shycocan- Scalene Hypercharge Corona Canon, is a small drum-like device, which can be fixed in offices, schools, malls, hotels, airports for disinfecting surfaces. 1595838646_bengaluru A Bengaluru-based organisation received approvals from the US Food and Drug Administration and…
Re-Envisioning Clinical Trials During The COVID-19 Pandemic
The COVID-19 pandemic has rapidly transformed much of the medical device, pharmaceutical, and vaccine industries. As Mary McDermott and Anne Newman note in JAMA, “Mitigation efforts [against COVID-19] interfere with all aspects of a successful clinical trial: efficient accrual and…
Using a global network of adaptive clinical trials to fight Covid-19
Viruses like SARS-CoV-2 can circle the globe with astonishing speed by taking advantage of human networks. The global medical research community couldn’t immediately contain it because it had no comparable network for defense — but we are moving quickly to…
