As 2025 makes its debut, one of the topics gaining momentum in health care is the diagnosis and potential treatment of neurodegenerative diseases, a scourge that threatens to overwhelm society and drain treatment budgets around the world. One company looking to find solutions to the oncoming neurodegenerative disease tsunami is privately held Sunbird Bio Inc., which is developing blood-based diagnostic platform for neurological diseases like Alzheimer’s and Parkinson’s disease.
U.S. Medicare coverage of renal denervation (RDN) for uncontrolled hypertension may soon be a fact of life if the manufacturers of these systems have their way. CMS opened a national coverage analysis for RDN, but as is routine practice recently, the agency is asking for comment before posting even a draft coverage memo for this technology.
In a deal potentially worth $810 million for Regenxbio Inc., Nippon Shinyaku Co. Ltd. is partnering on the U.S. and Asian development and commercialization of iduronate-2-sulfatase enzyme RGX-121 for Hunter syndrome and RGX-111 for Hurler syndrome.
Gilead Sciences Inc. is moving further into inflammatory diseases in a potential $1.7 billion deal with Leo Pharma A/S around a preclinical oral signal transduction and activator of transcription 6 (STAT6) program that the Danish dermatology specialist has been working on since 2018.
Shares of Phio Pharmaceuticals Corp. soared 291% Jan. 13 on news that two patients with cutaneous squamous cell carcinoma had a complete response following treatment with the company’s Intasyl siRNA gene silencing candidate PH-762.
Joining the dealmaking spree to kick off the 2025 J.P. Morgan Healthcare Conference, Eli Lilly and Co. announced it was picking up an early clinical-stage PI3Kα inhibitor program from Scorpion Therapeutics Inc. in a deal that could be worth up to $2.5 billion, while GSK plc is adding to its cancer pipeline with the acquisition of Idrx Inc. for $1 billion up front.
Quanterix Corp. plans to merge with Akoya Biosciences Inc., in an all-stock transaction that both companies hope will bolster their fortunes. The transaction will create an integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers.
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance. The Advanced Medical Technology Association stated that FDA reviewers asked for full conformity test results for roughly 5% of premarket applications, a rate seen as excessive given the program’s design.
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
In the first patenting to emerge from Carlsbad, Calif.-based Biologic Input Output Systems Inc., its chief development officer, Timothy Miller, collaborated with academics on the development of implantable neural interfaces for placement in the peripheral nervous system.
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