FDA Policy/General

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Shire has agreed to sell its oncology business for $2.4 billion to Servier. The transaction includes in-market products Oncaspar (pegaspargase), a component of multi-agent treatment for acute lymphoblastic leukemia (ALL) and outside-the-U.S. rights to Onivyde (irinotecan pegylated liposomal formulation), a component of multi-agent treatment for metastatic pancreatic cancer post gemcitabine-based therapy. The portfolio also includes calaspargase pegol, which is under FDA review for treating ALL and early stage immuno-oncology pipeline collaborations.

Boston Scientific has acquired for an undisclosed amount nVision Medical, a privately-held company focused on women’s health. nVision developed the first device cleared by FDA to collect cells from the fallopian tubes, offering a potential platform for earlier diagnosis of ovarian cancer. Recent studies have confirmed that several major types of ovarian cancer appear to originate from the fallopian tube.

Alexion Pharmaceuticals has agreed to buy Stockholm, Sweden-based Wilson Therapeutics for $855 million. The transaction will give Alexion rights to WTX101, Wilson Therapeutics’ Phase 3 compound for Wilson disease, a rare genetic disorder that affects copper transport and affects the liver.

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