FDA Policy/General

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Boehringer Ingelheim has launched opnME.com, a new platform offering free and open access to selected pre-clinical molecules for non-clinical investigation to scientists worldwide. The company says the platform contains molecules for some of the most relevant targets in biomedical research, and they are being shared to foster “further independent and collaborative discovery as well as the identification of novel treatment approaches for patients.”

Shanghai Pharmaceuticals Holding Co. has agreed to buy Cardinal Health’s China drug distribution business for $557 million. The transaction is said the benefit Shanghai Pharma, China’s third largest drug distributor, in becoming a leading importer of foreign medicine into the world’s second-largest drug market.

U.S.-based Cue Biopharma has entered a strategic research collaboration and license agreement with Merck to focus on developing new biologics for treating autoimmune diseases. Cue is an immunotherapy company that focuses on new biologics that are engineered to selectively modulate the human immune system in order to treat cancer and autoimmune diseases. Under the deal, the company’s “Cue Biologics” platform will be used to develop products that would be engineered to selectively modulate disease-relevant T-cell subsets.

LivaNova has agreed to sell its Cardiac Rhythm Management (CRM)business to MicroPort Scientific for $190 million. The CRM develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failures. CRM products include high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers.

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