Biologics

Moderna Begins Dosing in Phase 3 Covid Vaccine Trial

Moderna says it has begun dosing participants in a Phase 3 study of its mRNA vaccine candidate (mRNA-1273) for Covid-19. The COVE (Coronavirus Efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority under HHS.

The study protocol is adhering to FDA guidance on clinical trial designs for Covid-19 vaccine studies, according to the company, adding that the randomized, placebo-controlled study is expected to include about 30,000 participants in the U.S. The primary endpoint will be the prevention of symptomatic Covid-19 disease and key secondary endpoints include prevention of severe Covid-19 disease (needing hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology, it says.

The company says it “remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 because of the company’s internal U.S. manufacturing capabilities and strategic collaboration with Lonza, Ltd. In addition, Moderna recently announced a collaboration with Catalent, Inc. for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility for the U.S., and with ROVI of Spain for fill-finish manufacturing outside the U.S.”

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