FDA Policy/General

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Alere shareholders have voted to approve the company’s acquisition by Abbott for $5.8 billion. Alere said that more than 98% of the votes cast at a special meeting voted in favor of the acquisition.

Chicago mayor Rahm Emanuel reportedly is supporting an ordinance that would require pharmaceutical sales representatives to carry a special license to work. The ordinance, purportedly intended to combat opioid abuse, would impose a $750 annual licensing fee per sales rep p and mandate recordkeeping on sales practices. The reps would have to: track the number of health care professionals they contact, note whether the pharmaceutical company pays health care professionals for their time, describe the pharmaceuticals promoted, and disclose whether the reps leave samples with health care providers.

Braeburn Pharmaceuticals and Camurus have expanded their collaboration and license agreement from 2014 to include buprenorphine combination products. The first drug candidate within the expanded scope, (CAM2058), is an extended release injectable combination of buprenorphine and granisetron in the FluidCrystal injection depot technology. CAM2058 has completed formulation development and non-clinical evaluation and is being transferred to clinical development during the fourth quarter of 2016 for preventing and treating postoperative pain, nausea and vomiting.

Isto Technologies, an orthobiologics company working to develop ways to repair and regenerate damaged or injured cartilage and bone, has acquired medical-device company Arteriocyte Medical Systems Inc. Isto Holdings will combine the two companies under the name Isto Biologics and focus on offering evidence-based solutions to expand its spine, orthopedics and functional-medicine product portfolios.

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