Drugs

Jazz Tremor Drug Misses Primary Endpoint

Jazz Pharmaceuticals says top-line results from its Phase 2b clinical trial (NCT05122650) evaluating the efficacy and safety of suvecaltamide in adult patients with essential tremor did not achieve statistical significance at 30mg versus placebo on the primary endpoint of change from baseline to week 12 on the Essential Tremor Rating Assessment Scale. It says the highly selective and state-dependent modulator of T-type calcium channels was well tolerated and the overall safety profile was consistent with previous studies with no new safety signals observed.

“While not statistically significant, numeric improvements were observed on the primary endpoint and key secondary endpoint at 30mg versus placebo,” Jazz says. “The improvement in placebo from baseline to week 12 also exceeded the company's expectations and was higher than what was observed for placebo in the prior T-CALM trial of suvecaltamide.”

On the safety side, the most common treatment-emergent adverse events were dizziness, headache, paresthesia, diarrhea and insomnia.

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