Pacira Sues to Block EXPAREL Generics After ANDA Filings
Pacira has sued WhiteOak and Qilu after ANDA filings for generic EXPAREL, initiating a 30-month FDA stay and strengthening its defense of 21 Orange Book patents.
News
AI Wearable EPISERAS Predicts Seizures in Real Time
Neuraxpharm and mjn-neuro will launch EPISERAS, an AI-based earpiece that predicts seizures minutes in advance, offering real-time alerts for patients with drug-resistant epilepsy.
Repatha Shows Sustained CV Benefit in Largest RWE Study
RWE Demonstrates Significant Four-Year MACE Reduction Repatha (Evolocumab), Amgen’s PCSK9 inhibitor, has once again demonstrated its cardiovascular impact, this time in a real-world population exceeding 110,000 patients. New findings presented at the American Heart Association Scientific Sessions 2025 show that the therapy delivers sustained, long-term reductions in major adverse cardiovascular events (MACE) for patients with … Read more
CMS, Medicaid Expand 2026 Coverage for Five Emerging Health Technologies
Broader 2026 Coverage Enhances Economics Across Multiple Care Settings A sweeping set of CMS and Medicaid reimbursement decisions is reshaping 2026 access across neuromodulation, electrophysiology, advanced wound reconstruction, diagnostic testing, and regenerative biologics. From APC assignments and ASC approvals to national pricing and expanded Medicaid coverage, these updates strengthen commercial readiness for emerging technologies while … Read more
CMS Unveils 2027 Negotiated Prices, Delivering Major Savings Across 15 Drugs
CMS has issued the CY 2026 ESRD PPS final rule, introducing a higher base rate, new geographic adjustments, revised outlier policies, and changes to the ESRD Quality Incentive Program.
Merck Canada and pCPA Complete WINREVAIR Negotiations, Advancing Public Reimbursement Pathway for PAH
Sotatercept Nears Public Coverage After National Pricing Deal Merck Canada has completed national pricing negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR (sotatercept), marking a significant milestone in the therapy’s journey toward broad public reimbursement across Canada. The agreement, announced on November 20, 2025, positions the first-in-class activin signaling inhibitor one step closer to … Read more
HITAP Launches Global Research Unit to Strengthen Evidence-Informed Health Policy Across LMICs
Thailand’s HITAP has established the Global Research Unit to address policy questions that traditional HTA cannot fully answer.
France Strengthens Cancer Access with TEVIMBRA and New 14-Day Trial Fast-Track
Breaking Down TEVIMBRA Access and the 14-Day Trial Pathway France has taken two decisive steps to reinforce its clinical research ecosystem and expand access to new oncology therapies. The Haute Autorité de Santé (HAS) has issued a favourable reimbursement opinion for TEVIMBRA (tislelizumab) in gastric and oesophageal cancers, while the National Agency for the Safety … Read more
NICE Issues Two Major 2025 Approvals: Vutrisiran for ATTR-CM and Aucatzyl CAR-T for R/R B-ALL
NICE has issued two major decisions: recommending vutrisiran for adult ATTR-CM and approving Aucatzyl CAR-T for relapsed or refractory B-ALL in adults.
CMS Sets New Medicare 2026 Rates Across Five Innovation Categories
What the New Medicare 2026 Rates Mean for Access and Adoption The U.S. Centers for Medicare & Medicaid Services (CMS) has delivered a rare cluster of reimbursement decisions that collectively mark one of the most significant access-defining weeks of 2025. Spanning neuromodulation, molecular diagnostics, AI imaging, autoimmune disease therapy, and oncology support care, the rulings … Read more