Drugs

Alpha Cognition’s Zunveyl OK’d for Alzheimer’s

FDA has approved an Alpha Cognition NDA for ZUNVEYL (benzgalantamine) for treating mild-to-moderate Alzheimer’s disease (AD). The drug has been designed with a dual mechanism of action to eliminate drug absorption in the gastrointestinal (GI) tract, “potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine,” the company says. “Tolerability affects therapy adherence, with data showing that 55% of AD patients discontinue their medication after one year, mainly due to GI side effects and insomnia.”

Zunveyl is described as a prodrug of AD treatment galantamine and an acetylcholinesterase inhibitor, and is believed to work by preventing the breakdown of acetylcholine, an important brain neurotransmitter involved in memory, motivation, and attention functions. Its approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of Zunveyl compared to galantamine immediate-release tablets and galantamine extended-release capsules, Alpha Cognition says.

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