FDA Policy/General

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Celgene has agreed to acquire Delinia Inc., a privately held biotechnology company developing novel therapeutics for autoimmune disease.The $300 million transaction expands Celgene’s inflammation and immunology pipeline through the acquisition of Delinia’s lead program, DEL106, a novel IL-2 mutein Fc fusion protein . The therapy is designed to preferentially upregulate regulatory T cells, immune cells that are critical to maintaining natural self-tolerance and immune system homeostasis.

Ferring Pharmaceuticals and Enteris BioPharma have entered into a license agreement and initiated an early development agreement to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence, to engineer an oral formulation of a peptide-based injectable therapeutic developed by Ferring.

Vention Medical has acquired Israeli nitinol wire component maker Lithotech Medical. The acquisition grows Vention’s portfolio of advanced components and technology for the developing and manufacturing medical devices.

Varian Medical has completed a $600 million spin-out of its imaging components business, Varex Imaging. Varex makes X-ray tubes, flat-panel detectors, connectors and accessories for imaging, as well as supplying workstations and software for computer-aided diagnostics and image processing.

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