FDA Policy/General

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Novanta has acquired privately-held Zettlex Holdings and its inductive encoders that can provide absolute and accurate positioning even in extreme operating environments. Novanta says there is a growing demand for precision motion technology in robotics, precision automation and key medical markets.

Janssen Biotech has agreed to purchase HC2 Holdings in a deal that could be worth more than $1 billion. The transaction give Janssen the rights to BeneVir’s proprietary T-Stealth Oncolytic Virus Platform that can be used to develop oncolytic viruses used to infect and destroy cancer cells.

United Therapeutics has agreed to acquire SteadyMed for $216 million. , including $75 million in contingent consideration. The transaction gives United Therapeutics access to SteadyMed’s experimental combination therapy Trevyent for the subcutaneous treatment of pulmonary arterial hypertension.

Biomerics and ATL Technology have entered into a joint venture to acquire Catheter Research’s assets, which include interventional catheters, tube sets, and other assemblies for medical devices with expertise in tube extrusion, catheter assembly, and final FDA product packaging for sterilization. Catheter Research services original equipment manufacturer customers as well as sell their own catheter line under the Thomas Medical brand.

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