Drugs

FDA Finalizing ALS Guidance Next Month

FDA commissioner Ned Sharpless says that it plans to release a final guidance on developing amyotrophic lateral sclerosis (ALS) drugs and biologics products by the end of September. “Patients are at the forefront of everything we do, and FDA remains deeply committed to supporting the (ALS) community in its efforts to fight the toll that this devastating disease takes on all those affected by it,” he said in a twitter post late last week.

The agency’s “Draft Guidance for Industry – Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment,” was posted 2/18. “Despite the availability of some approved therapies, there is an urgent need to identify additional effective treatments for patients with ALS,” FDA said at the time. “We’ve been honored to work with the ALS Association to advance these goals. The ALS Association put together a comprehensive proposed draft guidance of their own, funded by the famous ‘ice bucket challenge.’ This proposed draft guidance, in turn, provided the FDA with scientific advice and insight into the disease that helped us advance our own draft guidance that provides our clear thinking on drug development in this area.”

Shortly after revealing the agency’s guidance plans, Sharpless received a number of Twitter replies from ALS patients asking that FDA fast track NurOwn, an investigational therapy developed by BrainStorm Cell Therapeutics, that uses a mesenchymal stem cell platform to treat ALS patients. A Phase 3, randomized, double-blind, placebo-controlled clinical trial (NCT03280056) is currently recruiting participants who will receive repeated intrathecal doses of either NurOwn or a placebo over a 28-week period.

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