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Astellas and Anokion will create Kanyos Bio to collaborate on developing new treatments for Type 1 diabetes and celiac disease.

DalCor Pharmaceuticals and the Montreal Heart Institute will conduct an international Phase 3 clinical trial seeking to validate the clinical efficacy of dalcetrapib, that according to an MHI published could reduce cardiovascular morbidity and mortality by as much as 39% in patients with a documented recent Acute Coronary Syndrome and with the appropriate genetic profile. DalCor has licensed dalcetrapib from Roche.

BD Medical, a segment of Becton, Dickinson & Co., and Medtronic will collaborate to introduce a new insulin pump infusion set with BD FlowSmart technology. According to the companies, Medtronic will commercialize the infusion set, while BD manufactures the product in efforts to improve infusion set options for people with diabetes using insulin pumps.

Celtaxsys says it has completed a $40 million Series D financing, which will be supplemented by a $5 million grant from the Cystic Fibrosis Foundation Therapeutics, to help fund the company’s Phase 2 safety and efficacy trial of CTX-4430, a once daily, oral anti-inflammatory medicine for preserving lung function in cystic fibrosis patients. The company says CTX-4430 has been granted Orphan Drug Designation by FDA.

Orexigen Therapeutics and its North American partner, Takeda Pharmaceuticals have filed a lawsuit in the U.S. District Court for the District of Delaware against Actavis in response to the company’s filing of an ANDA for a generic of the weight loss drug Contrave (naltrexone HCl / bupropion HCl extended release) tablets prior to the expiration of U.S. patents listed in the Orange Book.

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