FDA Policy/General

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Forward Pharma A/S has entered into a binding agreement with two wholly owned subsidiaries of Biogen and certain other parties. Under the agreement, Biogen will pay Forward $1.25 billion and it will be obligated to pay Forward royalties of up to 10-20% of net sales of Biogen products, including Tecfidera, approved for treating multiple sclerosis that are covered by a Forward patent and have dimethyl fumarate as an active pharmaceutical ingredient.

Novan has entered into an exclusive license agreement with Sato Pharmaceutical Co., a Japanese company with a prescription pharmaceutical business specializing in dermatology. Under the agreement, Sato will pay Novan an initial payment of $11.0 million for the exclusive rights to develop and commercialize in Japan Novan’s topical nitric oxide-releasing product candidate SB204 and related dosage forms for the treatment of acne vulgaris.

Intas Pharmaceuticals Ltd., through its wholly owned subsidiary Accord Healthcare Ltd., has acquired Actavis UK Ltd. and Actavis Ireland Ltd. from Teva Pharmaceutical Industries Ltd. for £603 million. The transaction is part of the European Commission’s anti-trust divestiture requirements arising from Teva’s acquisition of Allergan’s generics business.

Hill-Rom has signed a definitive agreement to acquire Mortara Instrument Inc. for $330 million. Integration of Mortara’s portfolio is expected to expand and enhance Hill-Rom’s offerings in the diagnostic cardiology and vital sign monitoring markets, as well as accelerate growth for Mortara technology on a global scale.

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