FDA Policy/General

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OncoImmune has entered into an exclusive option and license agreement with Pfizer for ONC-392, a novel, differentiated preclinical anti-CTLA4 monoclonal antibody, in a deal worth up to $250 million in upfront and potential milestone payments. Under the terms of the agreement, Pfizer plans to evaluate ONC-392 up until a certain agreed-upon time to determine whether it will exercise its option to exclusively license ONC-392 as well as any other OncoImmune anti-CTLA4 antibodies.

Horizon Discovery Group has entered into a collaboration with Fulcrum Therapeutics that will utilize Horizon’s CRISPR-based screening platform to identify novel targets for regulating gene expression. The program will initially focus on genetic diseases where no effective treatment options currently exist.

Zimmer Biomet Holdings has acquired Clinical Graphics, an imaging company specializing in 3D range-of-motion simulation technology to inform treatment decisions for common hip conditions requiring early intervention. Zimmer plans to integrate the new imaging platform to enhance its hip preservation portfolio.

Johnson & Johnson has announced a definitive agreement to acquire Abbott Medical Optics for $4.325 billion in cash. The acquisition will include ophthalmic products in three business segments: cataract surgery, laser refractive surgery and consumer eye health.

GE says it will invest $150 million in a new biopharmaceutical manufacturing campus in Cork, Ireland. GE BioPark Cork will feature Europe’s first KUBio, prefabricated, off-the-shelf bio-manufacturing facilities, owned and run by GE customers, that will serve as a focal point for further investment in next-generation biopharmaceutical manufacturing in Ireland.

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