FDA Policy/General

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Sanofi and Google’s life sciences firm Verily say they will invest $500 million in a diabetes joint venture called Onduo that is intended to develop comprehensive solutions that combine devices, software, medicine, and professional care for disease management. The enterprise, which is based in Kendall Square in Cambridge, MA, will leverage Verily’s experience in miniaturized electronics, analytics, and consumer software development, and Sanofi’s clinical expertise and experience in bringing innovative treatments to market, the two companies say.

Aptar Pharma has entered into an exclusive development and license agreement with Becton Dickinson (BD) to jointly develop a novel auto-injector using Aptar’s high-performance, two-step auto-injector technology and prefillable syringes from BD.

Aralez Pharmaceuticals has acquired the U.S. and Canadian rights to Zontivity (vorapaxar) from Merck. Zontivity is designed to inhibit the protease-activated receptor-1, the primary receptor for thrombin, which is considered to be the most potent activator of platelets. In the U.S., it is indicated for reducing thrombotic cardiovascular events in patients with a history of heart attack or in patients peripheral arterial disease.

Varian Medical Systems has acquired the radiotherapy business of Candela, a leading distributor of radiotherapy equipment in Poland. Warsaw-based Candela has represented Varian in Poland for the past 20 years. Varian says there are currently more than 80 of its medical linear accelerators installed in Polish radiotherapy departments.

Kelpac Medical, a medical packaging and tubing solutions provider and a subsidiary of PPC Industries, has acquired medical device contract manufacturer Xeridiem Medical Devices from Fenner. The $10.5m cash deal gives Kelpac access to specialty products offered by Xeridiem, including liquid injection moulding, silicone extrusive and silicone device assembly, which will be offered to its new and existing customers.

Horizon Pharma has agreed to buy Raptor Pharmaceutical Corp. for about $800 million to increase its rare-disease treatment business. As part of the deal, Horizon will acquire Procysbi, a treatment for nephropathic cystinosis, and Quinsair, a therapy for cystic fibrosis patients. Raptor is expected to have about $130 million is sales this year.

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