FDA Policy/General

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Boston Scientific has acquired the gynecology and urology portfolio of Distal Access, a Salt Lake City-based company that designs minimally invasive medical devices. The portfolio includes the Resectr Tissue Resection Device, a single-use device for removing uterine polyps.

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. The two companies will combine under the name Isto Biologics and focus on expanding its spine, orthopedics and functional-medicine product portfolios.

Absorption Systems has renewed a technology licensing deal with Biogen. The license covers MDR1-MDCK cells, a cell line that is transfected with the human MDR1 gene, which codes for a protein known as multi-drug resistance protein or P-glycoprotein (P-gp). Drug transporters such as P-gp have received increasing attention from regulators because of their importance in drug absorption, excretion, and safety. The licensed assay system enables Biogen to test new drug candidates for interactions with P-gp, which is involved in resistance of tumors to anticancer drugs, drug distribution and clearance, and drug-drug interactions.

Novartis has agreed to pay up to $665 million Selexys Pharmaceuticals Corp., an Oklahoma City company developing therapeutics for treating certain hematologic and inflammatory disorders. In 2012, Novartis obtained the exclusive right to acquire Selexys and the drug SelG1. Novartis said it exercised rights to buy the company after seeing results from a large trial into a drug to treat pain among those with sickle cell disease.

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