FDA Policy/General

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Ligand Pharmaceuticals has entered into a worldwide license agreement with xCella Biosciences to permit xCella to use the OmniRat, OmniMouse and OmniFlicplatforms to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual platform access payments, development and regulatory milestone payments and royalties for each product incorporating an OmniAb antibody. xCella will be responsible for all costs related to the programs.

Janssen Pharmaceutical Companies has entered into a worldwide exclusive license and collaboration agreement with Protagonist Therapeutics to develop, manufacture, and commercialize PTG-200, an oral interleukin-23 receptor (IL-23R) antagonist drug candidate for treating Crohn’s disease and ulcerative colitis. Under the agreement, Protagonist will receive an upfront payment and is eligible to receive development and commercialization milestone payments. If PTG-200 is commercialized, Protagonist would be eligible to receive royalties on net sales and will also have the option to co-detail in the US.

EnteroMedics, a developer of medical devices treating obesity, metabolic diseases and other gastrointestinal disorders, has acquired the Gastric Vest System through its acquisition of BarioSurg, Inc. The Gastric Vest is an investigational, minimally-invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients. The device, which wraps around the stomach and emulates the effect of conventional weight loss surgery, enables gastric volume reduction without permanently changing patient anatomy.

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