FDA Policy/General

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BioDelivery Sciences International has entered into an agreement with Endo Pharmaceuticals to terminate Endo’s licensing rights for pain drug Belbuca (buprenorphine) buccal film. As a result of the agreement, the world-wide rights to Belbuca will be transferred back to BioDelivery Sciences on undisclosed terms. Annual sales for the product are about $27 million.

Vanda Pharmaceuticals has entered into a license agreement with Apotex to resolve Vanda’s patent litigation against Apotex and its ANDA seeking approval for a generic version of Vanda’s Fanapt (iloperidone). Under the agreement, Vanda granted Apotex a non-exclusive license to manufacture and commercialize its generic Fanapt in the U.S. effective 11/2/2027. Apotex may enter the market earlier under certain limited circumstances.

JHL Biotech has signed a $257 million partnership agreement that gives Sanofi rights to market a JHL clinical-stage rituximab biosimilar, initially for China. Rituximab is used to treat autoimmune disorders, cancer and transplant rejection. JHL received approval to start a European Phase I trial for the rituximab biosimilar earlier this year.

A Chinese regulator has fined a local unit of Medtronic $17 million for price fixing related to the firm’s cardiovascular and diabetes medical device products. China’s National Development and Reform Commission said Medtronic had carried out monopolistic behavior with its distributors and local partners to fix prices and set lower limits on the resale price to hospitals.

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