Drugs

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Novartis has agreed to buy Bannockburn, Illinois-based AveXis for $8.7 billion. As part of the deal, Novartis will gain lead gene therapy candidate AVXS-101 for spinal muscular atrophy. A BLA submission is planned for the second half of this year.

Ferring Pharmaceuticals has agreed to acquire Rebiotix, a late-stage clinical microbiome company. Under the transaction, Ferring acquires Rebiotix’s lead program, RBX2660, a non-antibiotic treatment to prevent recurring Clostridium difficile infection, which is currently in a Phase 3 trial.

Roche has agreed to acquire Versant Ventures’ Inception 5 program, which is focused on regenerative therapies for multiple sclerosis. The acquisition is the latest action under a 2014 alliance between the companies to discover and develop novel small molecules that promote remyelination of nerve fibers damaged during the progression of multiple sclerosis.

Tekni-Plex has acquired Dunn Industries, a manufacturer of specialty extrusion tubing for medical device applications. Dunn also has expertise in a wide range of thermoplastic materials and offers both standard and custom-engineered tubing solutions. Its product line is also a complementary addition to the microextrusion tubing manufactured by Tekni-Plex's Natvar business unit.

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