Getinge AB agreed to acquire Paragonix Technologies Inc. for $477 million, including upfront and earn out payments. The deal marks Getinge’s entry into the global organ preservation and transportation market, a rapidly advancing field driven by rising transplant volumes, technological innovations and evolving clinical practices.
The ever-contentious issue of drug pricing creates a tug-of-war between biopharma’s innovation machine and the general population’s need for accessible and affordable drugs. BioWorld has covered the issue of drug pricing from insulin caps and the early days of the IRA to failed legal challenges and the recent rollout of the Centers for Medicare & Medicaid Services’ negotiated prices. Read our collection of 2024 stories.
With biopharma IPO volume at a 10-year low, two companies are bucking the trend with plans to plunge into the public market. Bifunctional antibody drug developers Bicara Therapeutics Inc. and Zenas Biopharma Inc. have filed with the SEC to go public though neither has named share-price ranges.
The long struggle by Boston-based I2o Therapeutics Inc.’s business unit Intarcia Therapeutics to get long-lasting exenatide for diabetes onto the market ended with a final thumbs-down from the U.S. FDA because of safety concerns. At issue was ITCA-650, a twice-yearly implantable exenatide-device combo meant to improve glycemic control in adults with type 2 diabetes.
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses was struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as planned on Sept. 4.
The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.
Stryker Corp. continued its aggressive M&A program this year with the planned acquisition of Vertos Medical Inc. Vertos offers a minimally invasive lumbar decompression (Mild) solution for chronic lower back pain caused by lumbar spinal stenosis. The announcement brings Stryker to six deals so far this year: Société d'Etudes, de Recherches et de Fabrication (SERF) SAS, Mfphd LLC, Artelon Inc., Molli Surgical Inc., Care.ai Inc. and now Vertos. Financial terms were not disclosed for any of the transactions.
The U.S. FDA’s draft guidance for predetermined change control protocols for all device types fills in a gap left by previous draft guidance, but there is one potential stopping point for class III devices.
A new brain-computer interface (BCI) developed at UC Davis Health is able to translate brain signals into speech with up to 97% accuracy – the most accurate system of its kind.
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses has been struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as had been planned on Sept. 4.
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