“Conditional” Approval Comes To US? Amylyx AMX0035 For ALS May Test Informal Approach After Positive Committee Vote And Sponsor Pledge To Pull NDA If Next Trial Fails

Prevision Policy Clips | Veru Sabizabulin EUA For High Risk COVID Patients Set For Advisory Committee

Prevision Policy Clips | Amylyx AMX0035 Returns To Committee: FDA Still Unconvinced Of Efficacy In ALS

Amylyx Take Two: FDA Reviewers Still Unpersuaded By AMX0035 Efficacy, But Framing For Advisory Committee Invites More Favorable Consideration Of Unmet Need In ALS

Advisory Committee Tracker: FDA Calendar For Fall Filling Up With Five New Meetings; Two Re-Submissions Add To List Of Troubled Reviews

Prevision Policy Clips | AstraZeneca/Avillion Asthma Rescue Inhaler PT 027 Set For Advisory Committee Review Nov. 8

Prevision Policy Clips | Y-mAbs Omburtamab For Neuroblastoma Heads To ODAC Oct. 28: Attempt To Recover From “Refuse-To-File” Letter

COVID-19 Bivalent Vaccine Authorized By FDA: Clinical Data Coming In Two Months; Agency Choosing To Retain Original Formula For Primary Series

“Re-Examining” Mandatory Prescriber Education, Opioid Approval Standards Are Priorities In FDA Opioid “Overdose Prevention” Framework

Prevision Policy Clips | Novo Nordisk GLP-1s Wegovy, Saxenda Fall Outside ICER Cost-Effectiveness Range

Migraine Prevention, Chronic Pain Treatment Guidances Added To FDA 2022 Agenda

Prevision Policy Clips | FDA Rejects San Rocco Citizen Petition Asking For An “Investigation” Attempting To Stop Bluebird Bio Zynteglo Licensure

Prevision Policy Clips | CMS “Dashboard” Of Part D Drug Payments Offers Guide To First 10 Blockbusters

Bluebird Bio Zynteglo 15-Year Follow-Up Is Lengthy, But Builds On Existing Work; FDA Reiterates Preference For Clinical Benefit Endpoints

One In Five Essential Medicine API Manufacturers Are US-Based, FDA Report Finds; Agency Continues To Benefit From Remote Inspections

Medicare Price Negotiation Pioneers: Top Candidates For Inaugural Class Of Price Reduction Targets Eliquis, Xtandi Could Be Bellwethers

Prevision Policy Clips | CMS Talking Points On Drug Pricing Reform Implementation Emphasize Insulin Co-Pay Cap And Premium Subsidies

FDA “Act For ALS” Action Plan Will Support Drug Development “In Real Time”; Agency Outlines First Steps In Five-Year Implementation

Prevision Policy Clips | CBER Director Marks Pressed Then-FDA Commissioner Hahn On COVID Vaccine EUA Guidance Decision

IRA Reset: Gene Therapies Have Price Model To Dodge “Drug Price Negotiation Program;” For Negotiated Products, Who Negotiates Matters

Prevision Policy Clips | FDA Looks To Broad Consortia To “Stimulate Progress In Evidence Generation”

FDA Will Allow Cost Distribution For Manufacturing, Administrative Startup For Expanded Access Programs, Updated Guidance Says

Prevision Policy Clips | Pfizer/BioNTech COVID-19 BA.4/5 Bivalent Vaccine Doses Will Be Ready For September Delivery

Amylyx ALS Drug Gets Positive Review By ICER Ahead Of Second FDA Advisory Panel; ICER Group Finds Expected Launch Price Too High

Prevision Policy Clips | Ipsen’s Palovarotene Heads To The Endocrinologic & Metabolic Drugs Advisory Committee Oct. 31