Lilly Opposes Broad Scope Of CMS Coverage Decision On Alzheimer MAbs; Biogen Urges Flexibility In Type Of Provider, Treatment Setting Allowed For Aduhelm

Prevision Policy Clips | CDER Director Cavazzoni In The Hot Seat? July 29 House Hearing

Advisory Committee Tracker: Gene Therapy Safety Update Is Highlight On Otherwise Sparse Agenda

Prevision Policy Clips | ANDA Filing Fee To Increase Almost 15%, FDA Says

Prevision Policy Clips | Bristol Withdraws Opdivo Hepatocellular Carcinoma Monotherapy Indication, One Of “Dangling” Accelerated Approvals

Prevision Policy Clips | FDA Adcomm to Discus Toxicity Risks of AAV Vector-Based Gene Therapies

CMS Views Aduhelm NCD As Class Coverage Decision With April 2022 Final Deadline

Prevision Policy Clips | Biogen Welcomes “Formal Review” Of FDA-Sponsor Interactions On Aduhelm

Avoiding The Next Addiction Crisis? Benzodiazepine Research Agenda Includes Deprescribing, Better Tapering Instructions, And Treatment Alternatives

Prevision Policy Clips | North Carolina GOP Sen. Burr Supports Woodcock for FDA Commissioner – and Aduhelm AA Decision

“Operation Warp Speed” Changing Gears To Long-Term HHS Countermeasure Preparedness; Supply Chain, Vaccine Boosters Are Key Issues At Senate COVID Update Hearing

Prevision Policy Clips | CBER Still Working Out "Relatively Complicated-Looking" Transition Period For COVID-19 Vaccines Out Of EUA Status

Thicket Pruning Ideas From Fresenius Would Cap Patents Asserted Against A Biosimilar; Sen. Klobuchar Shows Renewed Interest

Prevision Policy Clips | AbbVie, Lilly/Incyte JAK Inhibitor Reviews Will Miss PDUFA Dates As FDA Safety Review Continues

Aduhelm Medicare NCD Process Will Explore Many “Creative Ideas,” But Observational Studies Most Likely – Not Clinical Trials, McClellan Predicts

ICER Reviews Biogen’s Aduhelm: Net Health Benefit Has Not Been Shown In Alzheimer’s, FDA Chastised For “Hail Mary” In Granting Accelerated Approval

Roxadustat Rejected: AstraZeneca/FibroGen Rescue Plan For Novel Anemia Therapy NDA Fails; Path Forward May Require Focus On Narrow Indication

Prevision Policy Clips | Continuous Manufacturing Advances To House E&C Full Committee With Broader “Advanced” Tech

Prevision Policy Clips | $600 Billion In Rx Savings!? Tough Headline In Early Budget Reconciliation Plan

Prevision Policy Clips | Duke-Margolis Resiliency White Paper Urges Guaranteed Purchase Contracts

Aduhelm Medicare Coverage Review Will Run Through 2021, But Unlikely To Lead To Significant Limitations On Use Going Forward

FibroGen/AstraZeneca Roxadustat Heads To Committee: FDA Frames Non-Dialysis Indication More Favorably Than Dialysis; Revisiting ESA Safety Debates

Prevision Policy Clips | CMS Tackles Aduhelm Coverage Via Formal NCA Process

Prevision Policy Clips | FDA Acting Com. Woodcock’s Request For HHS Inspector General Aduhelm Approval Investigation

HHS Drug Pricing Plan Due In 45 Days Under Biden Executive Order: Low-Profile, Slow Walk On Rx Costs Continues; Canadian Imports Still A Threat (Not A Reality)