FDA Policy/General

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Menarini-Silicon Biosystems has completed its agreement to purchase all the assets and relevant business related to the CellSearch Circulating Tumor Cell System from Janssen Diagnostics. The FDA-cleared blood test is intended for detecting and enumerating circulating tumor cells (CTCs) to help manage patients with metastatic breast, prostate, and colorectal cancers.

Sartorius has acquired MKS Instruments AB, a leading specialist in data analytics software for modeling and optimizing biopharmaceutical development and manufacturing processes. Sartorius purchased the company for $72.5 million.

Sucampo Pharmaceuticals has acquired for $200 million privately-held Vtesse. The transaction gives Sucampo the rights to VTS-270, which is currently in a pivotal study evaluating its effectiveness in treating Niemann-Pick Disease Type C1.

Syneron has agreed to be acquired by private equity fund Apax Partners for about $397 million. Syneron, and its Candela brand, produce aesthetic medical equipment including body contouring, hair removal and wrinkle reduction devices.

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