FDA Policy/General

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AstraZeneca has sold the European commercial rights to its beta-blocker heart drug Seloken and the associated fixed-dose combination Logimax to Italy-based Recordati for $300 million. Seloken (metroprolol) is used to control conditions such as hypertension, angina pectoris, disturbances of cardiac rhythm, maintenance treatment after myocardial infarction and functional heart disorders with palpitations. Logimax is the fixed-dose combination of metoprolol succinate with felodipine. It is indicated for the control of hypertension.

DePuy Synthes Products has acquired 3D printing technology from medical device company Tissue Regeneration Systems Inc. (TRS). The 3D printing methods developed by TRS will help enable DePuy Synthes to create patient-specific, bioresorbable implants with a unique mineral coating intended to support bone healing in patients with orthopedic and craniomaxillofacial deformities and injuries. Financial terms of the transaction have not been disclosed.

Hitachi Chemical Co. America has acquired PCT Cell Therapy Services, a leading contract development and manufacturing organization for the cell therapy industry. The completed acquisition allows Hitachi Chemical to fully leverage PCT’s extensive experience in cell therapy development and manufacturing technology, wide-ranging manufacturing locations, sales network, and other resources to expand and strengthen its services in the U.S. and add services in Japan, Europe and other regions.

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