Drugs

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Mustang Bio has entered into a lease agreement with the UMass Medicine Science Park in Worcester, MA for a manufacturing facility to support the clinical development and commercialization of the company’s chimeric antigen receptor engineered T cell technology. The facility is expected to be operational for the production of personalized CAR T therapies in 2023. Mustang anticipates initially building cell-processing capabilities to support its lead CAR T product candidates MB-101 in glioblastoma, and MB-102 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm.

Neos Therapeutics, a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release products using its proprietary modified-release drug delivery and orally disintegrating tablet technologies, has rejected an unsolicited proposal from PDL to acquire all of the outstanding shares of Neos for $10.25 per share in cash. Neos’ board of directors said that PDL’s proposal undervalues Neos and does not reflect its strategic value and future prospects for continued growth and value creation.

Stryker Corp. has acquired control of VEXIM, a French medical device company that specializes in the development and sale of vertebral compression fracture (VCF) solutions. The company’s flagship product is the SpineJack system, a mechanical expandable VCF implant for fracture reduction and stabilization.

Smith and Nephew has acquired the medical technology company Rotation Medical, a developer of a novel tissue regeneration technology for shoulder rotator cuff repair. It uses a bioinductive implant to help tendons heal by inducing growth of new tendon-like tissue.

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