1. Pink Sheet

Not All mABs For Alzheimer’s Are Created Equal, Manufacturers Tell Medicare

 
• By Cathy Kelly

Lilly, Eisai and Genentech argue against CMS’s class-wide approach in its coverage for amyloid-directed monoclonal antibodies, predicting research on their in-development for Alzheimer’s drugs will provide confirmatory evidence of clinical benefit in the months ahead.

Data On Three Other mABs Expected In Coming Months • Source: Alamy

The Centers for Medicare and Medicaid Services should only condition Medicare coverage for monoclonal antibody drugs for Alzheimer’s disease on further evidence generation when confirmatory evidence is absent, instead of imposing additional clinical trial research requirements prospectively on all drugs in the class, Eli Lilly and Company urged in comments to the agency.

“We believe that CMS should finalize an NCD that provides for Medicare coverage of all anti-amyloid mABs in a core covered patient population where

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EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.