Prevision Policy Clips | RWD/RWE Data In NDAs/BLAs Should Be Flagged By Sponsors In Cover Letters To FDA

“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