Drugs

Lilly Seeking Neutralizing Antibody Monotherapy EUA

Lilly says it has asked FDA for an emergency use authorization (EUA) for its bamlanivimab neutralizing IgG1 monoclonal antibody as monotherapy in higher-risk patients who have recently been diagnosed with mild-to-moderate Covid-19. The company says it expects to submit an EUA request for combination therapy with its etesvimab recombinant fully human monoclonal neutralizing antibody in November pending clinical trial enrollment once additional safety data accumulate and sufficient supply is manufactured. It says there should be data to support a BLA for combination therapy as early as the second quarter of 2021.

Lilly Research Laboratory president Daniel Skovronsky says “We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat Covid-19 in patients with a high risk for serious outcomes.”

The company says it plans to start a pragmatic open-label study in the coming weeks, enrolling patients treated with either monotherapy or combination therapy, with a focus on collecting data on hospitalizations, deaths, and safety.

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