Biologics

Hold on Covid-19 Vaccine After WHO Inspection

FDA has placed a clinical hold on an Ocugen Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine Covaxin (BBV152). “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited's (BBIL) manufacturing facility,” the company says.

FDA has declined to grant Ocugen an emergency use authorization for Covaxin for active immunization to prevent Covid-19 in individuals aged two to 18 years of age. Ocugen says it plans to work with FDA to evaluate the regulatory pathway for the pediatric vaccine. Last year, Ocugen teamed with India-based Bharat Biotech to bring Covaxin — which it says 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. Ocugen says the WHO has added the vaccine to its list of vaccines authorized for emergency use, and over 100 countries have agreed to allow its use under mutual recognition of Covid-19 vaccination certificates from India.

Data earlier published in The Lancet showed 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

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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