Drugs

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SciClone Pharmaceuticals has agreed to be acquired for $605 million by a consortium of buyers, including GL Capital Management CP, Bank of China Group Investment, and Ascendent Capital Partners. SciClone is a specialty pharmaceutical company with significant commercial business in China. Its portfolio covers oncology, infectious diseases and cardiovascular disorders. Its lead product is Zadaxin (thymalfasin) for hepatitis B, hepatitis C and some cancers, and is approved in over 30 countries.

Valeant Pharmaceuticals has entered into an agreement to sell its iNova Pharmaceuticals business to a company jointly owned by funds advised and managed by Pacific Equity Partners and The Carlyle Group for $930 million in cash. iNova, which markets prescription and over-the-counter products in several areas, such as weight management, pain management, cardiology and cough and cold, and operates in more than 15 countries around the world.

Allergan says it will acquire medical device developer Keller Medical for an undisclosed sum. The privately held medical device company which developed the Keller Funnel, a cone-shaped, lubricated plastic funnel designed to reduce surgeon and patient contact during breast augmentation or reconstruction procedures. The device was originally launched in 2009, with a next-gen version released in 2014.

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