Drugs

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UroGen Pharma has licensed to Allergan the worldwide rights to UroGen’s RTGel delivery system technology for use with neurotoxins. RTGel has thermo-sensitive properties that enable it to convert from a liquid state when cold, into a gel once it reaches body temperature, which allows increased “residence time” for drugs mixed with the gel and instilled in the bladder.

Hanmi Pharmaceutical Co. has entered into an exclusive development and license agreement with Genentech to develop and commercialize Hanmi’s pan-RAF inhibitor, HM95573 which is currently in Phase 1 clinical development. Hanmi will receive an initial upfront payment of $80 million and is eligible to receive payments based on achievement of certain predetermined development, regulatory and commercialization milestones totaling up to $830 million.

Contract manufacturer Tecomet Inc. has acquired Mountainside Medical, a Boulder, CO maker of medical device components and surgical devices. Mountainside Medical makes instruments for minimally invasive surgeries as well as medical device components for clients, and it has a pipeline of new products in development.

TriFusion Devices, a 3D printing company that focuses on health care and sports equipment, has acquired Essentium Materials LLC, which focuses on fusing 3D printed parts to biomedical devices. Essentium’s technology will be used for prosthetic devices, sporting equipment and military devices.

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