Drugs

Emigality Misses Superiority in Clinical Trial

Eli Lilly says a head-to-head clinical trial comparing its migraine drug Emgality (galcanezumab-gnlm) to Pfizer’s Nurtec ODT (Rimegepant) did not meet the primary endpoint — Emgality’s statistical superiority to Nurtec. Lilly says the drugs’ response rates were similar, but Emgality “performed numerically better on key secondary endpoints” in the three-month trial. The primary endpoint in the 580-patient trial was defined as “statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days.” Lilly says it will disclose the full results of the CHALLENGE-MIG trial later this year.

Monoclonal antibody Emgality was approved 9/2018 for preventing migraines in adults. In 6/2019, it was approved for treating episodic cluster headaches in adults.

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