FDA Policy/General

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Quidel has entered into definitive agreements to acquire for $400 million the Triage MeterPro cardiovascular and toxicology assets and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers from Alere Inc. The products are being divested in order to obtain antitrust approvals required for Abbott’s pending acquisition of Alere.

Emergent BioSolutions has entered into an agreement to acquire the ACAM2000 (smallpox (vaccinia) vaccine, live) business from Sanofi in an all-cash transaction with a total value of up to $125 million. Under the deal, Emergent also acquires an existing 10-year contract with the Centers for Disease Control and Prevention with a remaining value of up to approximately $160 million for deliveries of ACAM2000 to the Strategic National Stockpile.

Shore Capital Partners is combining its medical device manufacturers Summit Medical and Shippert Medical under a new brand — Innovia Medical. Chicago-based private equity firm Shore says Innovia Medical will continue to manufacture and market the full-range of Summit Medical and Shippert Medical products, including Tissu-Trans, InstruSafe Instrument Protection Trays and Care Maintenance Products, EarPopper and Minne Ties Agile products. Product design, research, manufacturing, sales and customer service will continue to be based at the company’s St. Paul, MN and Denver, CO locations.

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