Drugs

FDA OK’s Cancer Drugs Faster/Sooner Than EMA: Study

A new JAMA online study finds that FDA is approving new oncology therapies much faster and sooner than its European regulatory counterparts. According to its findings, the study found that 89 new oncology therapies were approved by both FDA and the EMA from 2010 to 2019, but the U.S. agency approved 95% of the therapies first, with a median approval delay in Europe of eight months.

The study authors, researchers from Imperial College London, Mayo Clinic and various universities in the U.S., found that the median review time was 200 days for FDA and 426 days for the EMA. Sixty-four new licensing applications (72%) were submitted to the agency first, compared with 21 (23%) to the EMA. “Thirty-five oncology therapies (39%) were approved by the FDA prior to pivotal study publication, whereas only eight (9%) by the EMA,” they found, adding that this leaves “uncertainty for practitioners regarding clinical utility and safety of newly approved therapies.”

The authors note that shorter review times and earlier approval by FDA meant that more drugs were withdrawn from the market — three drugs by the agency and one by the EMA.

Additionally, the study said drug manufacturers submit regulatory documents earlier to FDA than the EMA partly due to “the greater market share and higher cost of new oncology therapies in the U.S. compared with Europe.”

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