FDA Policy/General

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Otsuka Pharmaceutical Co. has agreed to acquire Neurovance, a privately held clinical stage pharmaceutical company focused on attention-deficit hyperactivity disorder and related disorders. Under the terms of the agreement, Otsuka will provide an estimated $100 million in upfront payments at closing, up to $150 million in additional payments contingent on achievement of development and approval milestones.

Vertex Pharmaceuticals has agreed to pay up to $250 million for Concert Pharmaceuticals’ cystic fibrosis program. The transaction includes the research and preclinical cystic fibrosis programs of an experimental drug that modifies Kalydeco, one of Vertex’s existing cystic fibrosis treatments.

Johnson & Johnson has completed the acquisition of Abbott Medical Optics for $4.325 billion. The transaction includes ophthalmic products in three areas: cataract surgery, laser refractive surgery and consumer eye health. The product lines will be consolidated under the brand name Johnson & Johnson Vision.

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