Drugs

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Celgene has agreed to fully acquire Juno Therapeutics in a $9 billion deal. Two years ago, the company bought a small stake for $1 billion. The transaction gives Celgene access to Juno’s CAR-T cell technologies.

Sanofi has agreed to acquire Waltham, MA-based Bioverativ for about $11.6 billion. Last January, Bioverativ spun off from Cambridge, MA- based Biogen’s hemophilia group. The unit has two drugs, Eloctate for Hemophilia A and Alprolix for Hemophilia B.

Context Therapeutics has acquired the worldwide rights to Apristor(onapristone XR) from Arno Therapeutics for an undisclosed amount. Onapristone has reportedly established efficacy in two Phase 2 metastatic breast cancer clinical trials. Apristor works by blocking the binding of progesterone, a carcinogen, to the progesterone

RTI Surgical has agreed to purchase Zyga Technology and its SImmetry sacroiliac joint fusion system for an undisclosed amount. RTI says the transaction is aligned with its spine-focused expansion strategy to pursue niche differentiated products. SImmetry is designed to drive fusion and is supported by clinical data.

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