FDA Policy/General

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Otsuka Pharmaceutical and Medimetriks Pharmaceuticals have entered into a licensing agreement granting Medimetriks exclusive development and commercialization rights for a topical non-steroidal phosphodiesterase IV inhibitor, OPA-15406, in the U.S. and Puerto Rico for treating atopic dermatitis. According to the companies, OPA-15046 demonstrated clinically significant results vs. placebo in a Phase 2 clinical trial and reduced inflammation in affected skin by inhibiting production of cytokines and chemical mediators that are believed to cause the signs and symptoms of atopic dermatitis.

Aralez Pharmaceuticals announced the completion of the business combination of Pozen Inc. and Tribute Pharmaceuticals Canada, which will operate under Aralez Pharmaceuticals, a global specialty pharmaceutical company with operations in Canada, Ireland and the U.S. According to Aralez, its global headquarters is in Ontario, Canada, the U.S headquarters is planned to be in Princeton, NJ and the Irish headquarters is in Dublin.

Edwards Lifesciences has entered into an accelerated share repurchase agreement with Morgan Stanley & Co. to repurchase $325 million of its common stock, as part of a previously authorized program to repurchase up to $750 million of the company’s common stock.

Nuvo Research Inc. has agreed with Horizon Pharma to extend the term of a manufacturing agreement for producing Pennsaid 2% for the U.S. market to 12/31/2029. The companies says the agreement also provides for tiered pricing based on volumes of product supplied.

Rubicon Genomics has signed an agreement with Beckman Coulter Life Sciences for distribution of its ThruPLEX Plasma-seq kits for research applications. The kits enable liquid biopsies for research applications in cancer and other conditions by producing highly reproducible libraries for Illumina instruments from small amounts of cell-free DNA in plasma (from less than 1 ng up to 30 ng of cell-free DNA), according to the companies.

Egalet Corp. has signed a collaboration agreement with Septodont, under which Septodont will promote Sprix (ketorolac tromethamine) Nasal Spray exclusively to dentists in the U.S. According to the companies, Egalet will receive an upfront licensing fee, earn sales-based milestones and share in profits from net sales.

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