FDA Policy/General

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Baxter International has acquired two hemostat and sealant products from Mallinckrodt — Recothrom Thrombin topical (recombinant) and Preveleak Surgical Sealant that is used in vascular reconstruction. Under the transaction, Baxter paid an upfront payment of $153 million and agreed to potential contingent payments in the future.

H. Lundbeck has agreed to pay $123 million to acquire Prexton Therapeutics, a 2012 spinout from Merck, and its Phase 2 treatment for Parkinson’s disease, foliglurax. The therapy is being evaluated for the symptomatic treatment of off-time reduction in Parkinson’s disease and dyskinesia including levodopa-induced dyskinesia.

Platinum Equity has agreed to purchase Johnson & Johnson’s LifeScan unit for $2.1 billion. LifeScan manufactures and markets blood glucose monitoring products for the diabetes market.

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