G-BA Clears 2026 Launch of Biologic Substitution Rules
Germany has cleared the way for pharmacy-level substitution of prescribed biologics with lower-cost biosimilars starting in 2026.
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White House and London Clinch Drug-Pricing Deal With 25% UK Price Lift
The U.S. and U.K. have reached an agreement in principle that lifts U.K. net prices for new innovative medicines by 25 percent, caps VPAG repayments at 15 percent from 2026 onward, and exempts U.K.-origin pharmaceutical and medical goods from Section 232 tariffs.
NeuroPulse Daily: Advancing the Alzheimer’s Battle With Early Detection and Novel Mechanisms
The neurology sector moved on several fronts today, with developments spanning Alzheimer’s diagnostics, mitochondrial-targeted drug programs, neuromodulation evidence standards, glioblastoma immunotherapy, spine portfolio restructuring, and new work on surrogate markers in neurodegeneration. Taken together, the updates reflect a field shifting toward earlier disease interception, biomarker-driven precision, and evidence packages that anticipate payer scrutiny. Alzheimer’s continues … Read more
CMS Sets $1,352 Payment Rate for Pillar’s oncoReveal CDx
CMS has issued its final payment determination for Pillar Biosciences’ oncoReveal CDx, confirming a crosswalk-based national rate of $1,352.09, service beginning January 1, 2026. The decision, which aligns with CMS’ preliminary ruling from August, marks a meaningful advance for Medicare beneficiaries and reinforces oncoReveal CDx’s position as a front-line, multi-cancer NGS testing kit in the … Read more
NeuroPulse Daily: Key Moves in Fragile X, Meniere’s, DMD, Alzheimer’s Detection, and gMG Access
Today’s neurology cycle delivered four high-impact developments: Mirum’s Phase 2 start in Fragile X, FDA Breakthrough Therapy Designation for SPI-1005 in Meniere’s disease, the U.S. launch of KYMBEE for Duchenne muscular dystrophy, and Circular Genomics’ $15M Series A to advance circRNA-based Alzheimer’s detection.
Novo Nordisk Secures Breakthrough MASP-3 Asset in $2.1B Omeros Deal
Omeros has finalized the handoff of its clinical-stage MASP-3 monoclonal antibody zaltenibart (OMS906) to Novo Nordisk, closing a transaction that delivers immediate liquidity, removes near-term financing overhangs, and validates a complement-pathway mechanism increasingly viewed as one of the next competitive frontiers in immunology. The deal, first signed in mid-October, brings Omeros $240 million at closing … Read more
Korea Unlocks Breakthrough Access for Ultomiris and Jemperli
Korea delivered two breakthrough reimbursement decisions, opening transformative access to Ultomiris for refractory generalized myasthenia gravis and elevating Jemperli to first-line status in dMMR/MSI-H endometrial cancer.
Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24, 2025
The Reimbursement Landscape Recalibrates As we pause for the Thanksgiving holiday, a sincere thank-you to our readers and partners for your continued engagement. This week’s update reflects a period of meaningful policymaking momentum across major global agencies. Across the U.S., UK, France, Canada and Thailand, agencies delivered firm, directional decisions that shape how hospitals, clinics … Read more
Reimbursement Wins Reshape Access for SKYRIZI, Tagrisso, Cosentyx
Reimbursement Momentum Favours SKYRIZI, Tagrisso and Cosentyx Friday brought major reimbursement shifts in Canada and Korea, recalibrating near-term access in inflammatory bowel disease, EGFR-mutated lung cancer and hidradenitis suppurativa. AbbVie secured a major win in Canada as SKYRIZI moved closer to funded access for ulcerative colitis. In Korea, reimbursement recalibration strengthened Tagrisso’s advantage over Leclaza … Read more
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.