Biologics

AstraZeneca Nearing EUA Request for Covid Vaccine

AstraZeneca is planning to seek an emergency use authorization for its Covid-19 vaccine by early April after determining that it has met FDA data requirements. The company’s 32,000-person study has accumulated data on at least 150 cases of Covid-19, according to a Reuters report. As with the currently marketed Covid vaccines in the U.S., the number of Covid-19 cases among those who got the AstraZeneca vaccine compared with infections in those who received a placebo will determine how effective the vaccine is at preventing illness.

The vaccine has been authorized for use in more than 70 countries thus far, including the European Union, but it has had a shaky rollout, including supply shortages and some safety concerns. Many will be watching FDA’s review timeline and whether the vaccine’s worldwide safety experience will come under consideration at the agency. For example, safety concerns over reports of serious blood clots in some vaccine recipients have led several nations to pause administering the vaccine, Reuters notes. The European Medicines Agency said: “As of 9 March 2021, 22 cases of thromboembolic events had been reported among the 3 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.” A World Health Organization expert advisory committee is also looking into the matter.

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