FDA Policy/General

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Ariad Pharmaceuticals has agreed to be acquired by Takeda Pharmaceutical Co. in a deal valued at about $5.2 billion. Takeda will pay $24 in cash for each Ariad share owned for a premium of about 75% over Ariad’s recent closing price.

Astellas Pharma has completed an acquisition of Ganymed Pharmaceuticals AG, a biopharmaceutical company located in Mainz, Germany. Under the agreement, Astellas paid EUR 422 million to acquire 100% of the equity in Ganymed. In addition, Ganymed’s shareholders will become eligible to receive up to EUR 860 million in further contingent payments. Through the acquisition, Astellas will expand its oncology pipeline.

Agilent Technologies and Multiplicom announced that they have signed a definitive agreement under which Agilent will acquire Multiplicom, a European diagnostics company. Multiplicom, headquartered in Niel, Belgium, develops, manufactures and commercializes molecular-diagnostic solutions, provided as kits, which enable personalized medicine.

Vivo Capital and ZQ Capital have signed an agreement to acquire medical devices maker Angiotech Pharmaceuticals (Canada) for an undisclosed sum. Angiotech produces surgical instrument products, such as blades and sutures, including the Quill knotless tissue-closure device.

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