FDA Policy/General

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China’s Shandong Weigao Group Medical Polymer Co. has agreed to acquire U.S.-based Argon Medical Devices Holdings Inc. for $850 million. Weigao is involved in the production and sale of medical devices, orthopedic and blood purification products, and it has been seeking opportunities to grow its product portfolio.

Konica Minolta and Boston-based Invicro have entered into an agreement whereby Konica Minolta will acquire Invicro, a provider of imaging services and software for research and drug development. Invicro is a global contract research organization provides a software and analytics platform enabling streamlined large-scale data analytics across any quantitative biomarker readout. Konica Minolta expects the transaction to accelerate development of its new medical platform to advance precision medicine, discover new therapeutic targets and develop new technologies and therapeutics.

Avara Pharmaceutical Services has signed an agreement with GlaxoSmithKline to acquire Glaxo’s consumer healthcare manufacturing facility in Aiken, SC. Avara is a contract manufacturing and technical services organization providing both active pharmaceutical ingredient formulation and manufacturing, along with secondary formulation, and manufacturing and packaging of small molecule drugs.

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