JP Morgan Week featured notable developments in drugs, devices, diagnostics, and digital health. Johnson & Johnson paid $14.6 billion for Intra-Cellular Therapies, bolstering its neuroscience portfolio with CAPLYTA® and a strong mental health pipeline. Eli Lilly invested $2.5 billion in Scorpion Therapeutics’ PI3Kα inhibitor for hormone-positive breast cancer, while Bausch + Lomb expanded ophthalmology with Whitecap Biosciences’ glaucoma and geographic atrophy studies. Lantheus Holdings expanded Alzheimer’s diagnostics with Neuraceq® after acquiring Life Molecular Imaging for $350 million. BioMérieux expanded its acute diagnostic capabilities with SpinChip’s rapid proof-of-concept platform. Innovative therapies, such as Eli Lilly’s Omvoh® for Crohn’s disease and AstraZeneca’s DATROWAY for breast cancer, have received FDA and European approvals. Roche’s dual mRNA probes for B-cell malignancies and Paige’s FullFocus™ pathology viewer have also received significant endorsements, demonstrating industry progress.
Strategic Acquisitions
Johnson & Johnson acquires Intra-Cellular Therapies for $14.6 billion, expanding its neuroscience portfolio with CAPLYTA®, an oral treatment for schizophrenia and bipolar depression, and a clinical pipeline targeting generalized anxiety and Alzheimer’s related psychosis. Eli Lilly is acquiring Scorpion Therapeutics’ PI3Kα inhibitor program for up to $2.5 billion, with Scorpion forming a separate firm for its non-PI3Kα program. Bausch + Lomb acquires Whitecap Biosciences, focusing on glaucoma and GA clinical pathways, with plans to expand research and address unmet ophthalmic needs. Lantheus Holdings acquires Life Molecular Imaging Ltd. for $350 million, including Neuraceq, to enhance Alzheimer’s diagnostics portfolio and R&D presence, with completion expected in late 2025. BioMérieux has acquired SpinChip Diagnostics for €138 million, expanding its 20% ownership and diagnostic platform, which offers rapid, high-quality results.
Medicare Coverage
- GRAIL’s PATHFINDER study in Lancet Oncology reveals Galleri® MCED blood test’s potential for early cancer detection with minimal psychological impact, resulting in high satisfaction and willingness to continue testing.
- CMS is analyzing Medicare coverage for Medtronic’s Symplicity™ Spyral Renal Denervation System, a minimally invasive hypertension treatment, with expected Medicare coverage by October 2025.
- Santhera Pharmaceuticals recommends AGAMREE® for Duchenne muscular dystrophy treatment in patients aged 4 and older, offering a safer alternative to corticosteroids with reduced toxicity.
- Abbott has secured Medicare national coverage for its CardioMEMS HF System, a device that monitors pulmonary pressure in heart failure patients, enhancing management and reducing hospitalizations and mortality.
- ZoomCare now accepts Medicare and Medicare Advantage at 45 clinics in Oregon and Washington, providing efficient, 30-minute visits and enhanced care coordination through Athenahealth for 2.5 million Medicare patients.
- MedRhythms has announced CMS pricing for its InTandem rehabilitation system, a rental-based therapy for chronic stroke gait impairment, effective April 1, 2025.
- AliveCor has received CMS reimbursement approval for its Kardia™ 12L ECG System, which enhances hospital access to advanced heart health diagnostics and aids in cardiovascular condition diagnosis.
- ImmuCell Corporation settled an insurance claim for $426,587 due to production contamination events between 2022 and 2024, adding to a previously recognized $250,000.
- Santhera Pharmaceuticals has received NICE’s recommendation for AGAMREE® (vamorolone) for treating DMD in NHS England, Wales, and Northern Ireland, with UK launch preparations underway.
- Philips has corrected MCOT devices due to software errors, causing missed ECG events, resulting in 109 injuries and 2 deaths, requiring users to review patient data.
Regulatory Actions
Biotechnology companies have made significant regulatory advancements, including the FDA Breakthrough Device Designation for Pear Bio’s pTau 217 blood test, FDA Fast Track designation for Spinogenix’s SPG601, Orphan Drug Designation for IPS HEART, and Breakthrough Therapy Designation for Innovent Biologics’ IBI343 for advanced pancreatic ductal adenocarcinoma.
The FDA has accepted several biologics license applications for various treatments, including Eisai and Biogen’s LEQEMBI® for Alzheimer’s treatment, Foresee Pharmaceuticals’ CAMCEVI for advanced prostate cancer, AstraZeneca and Daiichi Sankyo’s Dato-DXd for advanced NSCLC, Arrowhead Pharmaceuticals’ plozasiran for familial chylomicronemia syndrome, and Zai Lab’s KarXT for schizophrenia treatment.
In the U.S., Incyte and Syndax’s Niktimvo™ was approved for chronic GVHD, while Eli Lilly’s Omvoh was approved for Crohn’s disease. In Europe, InflaRx’s GOHIBIC received exceptional approval for treating SARS-CoV-2-induced ARDS. HUTCHMED’s ORPATHYS® and Innovent Biologics’ Limertinib were approved for advanced lung cancer in China. Medical technology companies also announced significant regulatory milestones, such as Silver Bullet Therapeutics’ 510(k) study, Roche’s VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail, Paige’s FullFocus™ digital pathology image viewer, and SurGenTec’s OsteoFlo HydroFiber bone graft solution. MediBeacon’s Transdermal GFR System was approved by the FDA. Medtronic’s BrainSense™ Adaptive deep brain stimulation and BrainSense™ Electrode Identifier were approved for personalized therapy for Parkinson’s disease.
Patent Filings
DiFusion Technologies obtained a patent for their ZFUZE® biomaterial, which achieved a 93.4% lumbar spinal fusion success rate after six months. Annovis Bio acquired US patent permission for buntanetap, a treatment for acute brain and nerve damage that is now worldwide protected. BetterLife Pharma secured a composition of matter patent for BETR-001, a non-hallucinogenic LSD derivative, which is valid until 2042. OnPoint Surgical’s augmented reality-guided patent was honored at the 2024 Boston Invented Here! celebration. Femasys, Inc. has received a Notice of Allowance for its infertility therapy product FemaSeed®, which will expand its intellectual property portfolio when the patent expires in 2044.
