In early 2025, significant developments across the biopharmaceutical and medical device sectors shaped the healthcare landscape. Stryker’s $4.9 billion acquisition of Inari Medical, Transcarent’s $621 million deal for Accolade, and several FDA designations for investigational treatments, such as Johnson & Johnson’s nipocalimab, highlight industry advancements. Medicare’s rescinding of coverage for certain cancer genetic tests and NICE’s recommendation of Lynparza reflect the growing role of genetic testing in cancer treatment. Meanwhile, China’s NMPA has approved therapies like Astellas’ VYLOY™ and Merck’s GARDASIL®. Medical device companies, including Roche and Johnson & Johnson MedTech, secured key regulatory approvals, while notable IP milestones were achieved with Sen-Jam Pharmaceutical, Zetagen Therapeutics, and Woolsey Pharmaceuticals.
Strategic Acquisitions in Early 2025
In a series of strategic acquisitions to kick off 2025, Stryker has agreed to acquire Inari Medical for $4.9 billion, expanding into the peripheral vascular market. Transcarent is acquiring Accolade for $621 million to enhance its AI-powered healthcare services. Boston Scientific is acquiring Bolt Medical for $443 million to boost its intravascular lithotripsy platform. Hologic completed its $350 million acquisition of Gynesonics, adding the Sonata® System to its women’s health portfolio. Other notable deals include Biogen’s acquisition proposal for Sage Therapeutics, Bausch + Lomb acquiring Elios Vision, and Anatomage’s agreement to acquire BioDigital.
Medicare Coverage
Medicare contractors Novitas Solutions and FCSO have finalized local coverage determinations (LCDs) rescinding coverage for nine cancer genetic tests, limiting testing to patients with established or suspected cancer, effective February 2025. This decision follows public feedback on draft LCDs from 2022. Additionally, NICE has recommended Lynparza (olaparib) for NHS use in England and Wales, offering a precision medicine for HER2-negative, BRCA-mutated metastatic breast cancer, highlighting the growing role of genetic testing in cancer treatment.
Regulatory Actions
Several biopharmaceutical companies have received key FDA designations for their investigational treatments. Johnson & Johnson’s nipocalimab received Priority Review for generalized myasthenia gravis, while posdinemab for early Alzheimer’s disease received Fast Track. Marengo Therapeutics’ invikafusp alfa for advanced colorectal cancer and Star Therapeutics’ VGA039 for von Willebrand disease also received Fast Track status. AliveGen’s ALG-801 for pulmonary arterial hypertension earned the Orphan Drug Designation. AccurKardia’s AK+ Guard hyperkalemia detection software received Breakthrough Device Designation. China’s NMPA granted Breakthrough Therapy Designation to JW Therapeutics’ Carteyva® for relapsed or refractory large B-cell lymphoma.
Sentynl Therapeutics has received FDA acceptance and priority review for its NDA for CUTX-101, a potential first treatment for Menkes disease, with a PDUFA date of June 30, 2025. Dizal Pharmaceutical’s Sunvozertinib, an oral EGFR inhibitor for advanced NSCLC with EGFR exon 20 mutations, also received Priority Review, though the PDUFA date is not disclosed. Bayer submitted a supplemental NDA for KERENDIA® to expand its indication for heart failure patients with a left ventricular ejection fraction (LVEF) of ≥40%.
China’s NMPA-approved Astellas’ VYLOY™ (zolbetuximab) with chemotherapy for HER2-negative gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors, the first therapy targeting this biomarker. Merck’s GARDASIL® gained approval as China’s first HPV vaccine for males (9-26 years). Stallergenes Greer received European approval for Palforzia® for toddlers with peanut allergies.
Roche’s VENTANA DP 600 slide scanner, Fesarius Therapeutics’ DermiSphere hDRT, OXOS Medical’s MC2 Portable X-ray System, Simpson Interventions’ Shadow Catheter™, and Alleviant Medical’s no-implant atrial shunt received FDA clearances for advancements in diagnostics, wound care, and cardiovascular treatments. CapsoVision’s CapsoCam Plus® was FDA-approved for pediatric capsule endoscopy, and Revvity’s EUROIMMUN test for free testosterone measurement also gained clearance. Johnson & Johnson MedTech’s Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and Medtronic’s Harmony TPV system earned CE mark approvals for cardiac care, while Eyebright Medical’s Loong Crystal PR intraocular lens received Class III certification from China’s NMPA for advanced eye care.
Johnson & Johnson MedTech has temporarily paused all Varipulse pulsed field ablation (PFA) system as of January 5, 2025, following four reported neurovascular events during its U.S. External Evaluation. The company is investigating the root cause but assures no impact on commercial activities or cases outside the U.S. Integra Lifesciences received an FDA warning letter on December 19, 2024, for quality system issues at multiple facilities, resulting in shipping holds and voluntary recalls for certain products. While the FDA did not restrict manufacturing or shipping, premarket approval for related Class III devices will be delayed until the violations are resolved.
Patent Filings & Expansions
Sen-Jam Pharmaceutical has filed a patent application for a novel obesity and metabolic disorder treatment targeting chronic low-grade inflammation with a combination of a mast cell stabilizer, H1-antihistamine, and NSAIDs. Zetagen Therapeutics has expanded its global IP portfolio to 64 patents, focusing on new molecular entities for breast cancer. IceCure Medical has received an intention to grant notice from the European Patent Office for a cryogenic system connector, enhancing the XSense cryoablation system. Woolsey Pharmaceuticals has secured additional U.S. patents for BRAVYL® (oral fasudil) in treating ALS, including claims for reducing neurofilament light (NfL), further strengthening its ALS treatment portfolio.
