Pfizer COVID-19 Vaccine Easily Clears ACIP For Use In Adolescents, But Committee Skeptical Of CDC Policy To Allow Co-Administration With Other Vaccines

HHS Secretary Sounds Collaborative On Drug Pricing, Though Rhetorical Support For Negotiation Remains; Becerra Hears Bipartisan Praise For FDA’s Woodcock

Prevision Policy Clips | HHS Deputy Palm Confirmed By Senate; CMS Nominee Still Pending

COVID Vaccine Booster Strategy: Biden Administration Planning Free Doses For 2022 Using Existing Funds; Next Steps Will Depend On Congress (And The Virus)

Prevision Policy Clips | Pfizer/BioNTech COVID-19 Vaccine EUA For Adolescents Was “Relatively Straightforward” Decision

Prevision Policy Clips | Senate HELP COVID Hearing May 11: FDA’s Marks May Have News

ChemoCentryx’ Avacopan: Split Committee Leaves FDA Flexibility To Demand A New Trial Prior To Approval For AAV – Or Grant A Narrow Label In Already Rare Condition

Prevision Policy Clips | ACIP To Consider Pfizer/BioNTech COVID Vaccine In 12-15 Year-Olds At May 12 Meeting

Rare Disease Drugs Would Not Be Affected By HR 3 Price Negotiations, House E&C Hearing Told; “Guardrails” In Place To Protect Small-Market Products

FDA Inspection Backlog: One-Quarter Of Domestic Visits Can Be Cleared In FY 2021; About 50 NDAs Have Been Delayed Solely Due To COVID Pandemic

FDA Research On “Sameness” For Oligonucleotide Products Is Ongoing; Drug-Device Combos Are Priority For Product-Specific Guidances

Prevision Policy Clips | MCIT Final Rule Defining “Reasonable And Necessary” For Medicare Coverage Will Move Forward

House Pushing HR 3 Drug Pricing Bill (Again) With Dual Hearings; Everyone Agrees There’s A Problem – But Not On The Solution

Biden Administration Backs IP Waiver For COVID Vaccines: One Off Event Or Sign Of Things To Come?

Prevision Policy Clips | HHS Secretary Becerra Will Testify At House E&C Budget Hearing May 12

ChemoCentryx’ Avacopan For AAV: FDA Questions Design And Interpretation Of Single Trial Heading To Panel; “Steroid Sparing” Claim In Doubt Even If Approval Is Supported

Prevision Policy Clips | House E&C Drug Pricing/HR3 Hearing Will Hear Caution On Medicare Inflation Rebates

Advisory Committee Tracker: Another Landmark Diabetes Review In May; Provention May Get Positive Vote, But Approval Very Much In Doubt

Prevision Policy Clips | The Eagle Has Landed Former FDA Chief Scientist Luciana Borio As Board Member

FDA’s Pazdur Reasserts Influence Over ODAC With Split Vote On Opdivo In Second-Line Liver Cancer While Keytruda AA Unanimously Endorsed

Prevision Policy Clips | ODAC Accelerated Approval Review Is 4-2 In Favor Of Maintaining Indications

Merck Keytruda Third-Line Gastric Cancer Approval Likely To Be Pulled; Checkpoint Inhibitors Have Role, FDA Stresses – But Should Be At Earlier Stage

FDA Developing “N of 1” Therapy Requirements With Eye To Building Sustainable Business Models; CBER Needs 100 More Staffers To Meet Need, Marks Says

NTAP Extensions Proposed By CMS: Andexxa, Spravato Among Drugs In Line For Extra Year Of Enhanced Inpatient Payment By Medicare

Genentech’s Tecentriq, Merck’s Keytruda Take Different Routes To Protect Urothelial Indications: Coming-Soon Final Data; Continuing Unmet Need