FDA Policy/General

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Ipsen has entered into a definitive agreement to acquire from Sanofi for $88 million five consumer healthcare products in certain European territories. The most significant product is Prontalgine, an analgesic for treating moderate to severe pain. The portfolio also includes Buscopan, an antispasmodic; Suppositoria Glycerini, a laxative; and Mucothiol and Mucodyne, expectorants for cough and flu.

Allergen has agreed to acquire Zeltiq Aesthetics Inc. for $2.48 billion. Zeltiq makes and markets the CoolSculpting System, an FDA-approved process that simulates liposuction through a non-surgical fat-cooling procedure. The process is described by Zeltiq as the leading non-invasive fat reduction procedure in the body contouring industry.

Seattle Genetics has agreed to pay up to $2 billion to acquire exclusive worldwide rights to a cancer therapy from Immunomedics. In exchange for the rights to IMMU-132 (sacituzumab govitecan), an antibody drug conjugate in Phase 1/2 testing for the delivery of cytotoxic drugs to various types of tumors, including breast, lung and esophageal, Immunomedics will get $250 million upfront, with $1.7 billion in potential milestone payments and tiered double-digit royalties on potential sales.

Chinese biomed ApolloBio negotiated exclusive rights to develop Inovio’s lead DNA immunotherapeutic for human papillomavirus (HPV) VGX-3100 within China, Hong Kong, Macao, and Taiwan. The collaboration and license agreement covers development of VGX-3100 for treating and/or preventing precancerous HPV infections and HPV-driven dysplasias and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants.

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