FDA Policy/General

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Valeant Pharmaceuticals and EyeGate Pharmaceuticals have entered into a licensing agreement through which EyeGate has granted a subsidiary of Valeant exclusive, worldwide commercial and manufacturing rights to the EyeGate II Delivery System and EGP-437 combination product candidate for treating post-operative pain and inflammation in ocular surgery patients. This partnership follows a 2015 agreement in which Valeant secured an exclusive worldwide license for its subsidiary to this product for uveitis. Valeant has maintained its right of last negotiation to license the product for other indications.

Takeda Pharmaceutical Company has completed its acquisition of Ariad Pharmaceuticals for $24.00 per share in cash. The transaction gives Takeda the global potential of brigatinib, an investigational ALK inhibitor for non-small cell lung cancer with the potential to achieve annual sales of over $1 billion.

MedPlast has signed a definitive agreement to acquire Vention Medical’s device manufacturing services business. The acquisition broadens MedPlast’s capabilities in assembly and packaging, enabling it to offer customers a comprehensive suite of services producing a wide range of medical products.

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