Biologics

FDA Puts Clinical Hold on Ocugen Covid Vaccine

FDA has issued a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the company’s Covid-19 vaccine candidate, BBV152, which is known as Covaxin outside the U.S. The company is awaiting formal written communication from the agency that will outline the deficiencies. Earlier this year, Ocugen teamed with India-based Bharat Biotech aimed at bringing Covaxin — which is approved for use in India and 16 other countries — to the U.S.

Covaxin is described as a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. The company says more than 100 million doses have been administered to adults outside the U.S. The WHO recently added the vaccine to its list of vaccines authorized for emergency use, and over 100 countries have agreed allow its use under mutual recognition of Covid-19 vaccination certificates from India.

Data recently published in The Lancet show that Covaxin demonstrated 77.8% overall efficacy, including 63.6% efficacy against asymptomatic disease and 65.2% efficacy against the Delta variant in a Phase 3 clinical trial involving nearly 25,800 participants.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome