FDA Policy/General

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LabCorp has acquired the assets of the Mount Sinai Health System Clinical Outreach Laboratories, and LabCorp is now available to provide comprehensive laboratory services to physicians and patients that previously used the outreach laboratory.

Xenon Pharmaceuticals has acquired from 1st Order Pharmaceuticals XEN1101, a potassium channel modulator for the potential treatment of epilepsy. Xenon anticipates filing an IND to initiate a Phase 1 trial in the fourth quarter.

Savara, a clinical-stage specialty pharmaceutical company focused on developing novel therapies for treating serious or life-threatening rare respiratory diseases, has merged with Mast Therapeutics. The merger adds three inhaled product candidates to Savara’s product pipeline.

Olympus has signed a definitive agreement to acquire Image Stream Medical, Inc., a healthcare systems integrator based in Littleton, MA. Image Stream’s technology has made “sophisticated visualization and healthcare environment integration for their customers simple and intuitive,” the companies say.

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