Prevision Policy Clips | Interchangeable Humira To Launch In 2023: Boehringer-Ingelheim Adalimumab Copy Cyltezo

Mix/Match COVID-19 Vaccine Boosters Endorsed By FDA Committee For Practical Reasons; “General Language” On Mixing Doses Could Be Added To EUAs

“Second Dose For All” For J&J’s COVID-19 Vaccine Clears Committee; Follow Up Discussion May Lead To Broader Booster Range For Pfizer And Moderna

Prevision Policy Clips | FDA Commissioner Califf? “Not Quite,” White House Press Secretary Says

Israeli Data, Recent Precedent Carry The Day For Moderna Booster; VRBPAC Not Going Broader On Indication As CBER’s Marks Worries About Winter Wave

Will Robert Califf Return As FDA Commissioner? Nothing Official, The Pick Fits The Biden Approach—And Favors The Status Quo

Prevision Policy Clips | More Than 80% Of Drugs Made Using Advanced Manufacturing Produced In US, FDA Spotlights Advanced Manufacturing Efforts

MedPAC Data Dump: Medicare Drug Rebate Information Will Fuel New Analyses To Test Arguments About Impact On Premiums, Point-Of-Sale Prices

J&J COVID-19 Vaccine Booster Expected To Clear FDA Committee Despite Data Limitations; Will Second Shot Be After Two Months, Six Months (Or Both)?

Prevision Policy Clips | BIO Head As FDA Nominee? Public Citizen Thinks The Chance Is Real, Urges Biden Administration Not To Do It

Moderna Will Likely Avoid Population Pitfalls In FDA COVID-19 Vaccine Booster Review; Miss On Co-Primary Endpoint Could Cause Committee To Go Off Track

MedPAC Turns To Part B: Reference Pricing, Accelerated Approval Value Assessments Among Policy Options That May Be Pursued

Treating PML: FDA/NIH Workshop Highlights Study Population, Endpoint Choice As Major Unresolved Issues For Drug Development

Prevision Policy Clips | Genentech Alzheimer’s Drug Gets FDA “Breakthrough Therapy” Designation

Takeda’s Maribavir Antiviral For Transplant CMV Treated As Tolerability Breakthrough; FDA Committee Accepts Contribution Of Tolerability To Efficacy

Prevision Policy Clips | FDA Adds MSK Tumor Mutation Database To Public Human Genetic Variant Database

Prevision Policy Clips | Proposed Rare Disease Center Of Excellence Is Premature: CBER Director Marks, OCE Director Pazdur Say

Proposed Rare Disease Center Of Excellence Is Premature; CBER Director Marks, OCE Director Pazdur Say Necessary Science, People Not Yet In Place

Lessons Learned From COVID EUAs: FDA Center Directors Say Statute Is Sound, But Want More Disclosure Authority; Device Center Response Plays Better To NAM Audience Than CBER Or CDER

Prevision Policy Clips | Drug Payment Models Ready To Go “If The Time Is Right,” But Still Waiting For Congress

Takeda Antiviral Maribavir: FDA Concerns About Pivotal Trial May Mean Narrow Indication For CMV; Unmet Need Should Win Approval Vote

Prevision Policy Clips | NIH Director Collins’ Departure Could Have Ripple Effects On Drug Pricing Debate

Prevision Policy Clips | Trick Or Treat: With CBER Director Marks In Charge, October Dates Set For Pediatric, Moderna/J&J Booster Advisory Committee Reviews

Can Too Costly Still Be A Good Deal? ICER Panel Weighs Argenx Pricing Plan For Pending Myasthenia Gravis Therapy Efgartigimod Versus Alexion’s Soliris

Putting The Placebo In Placebo-Control: Rough Lessons Learned From COVID-19 Therapeutic Development; FDA Explains HHS/DoD Learnings Document To RUF (Reagan-Udall Foundation)