“Basket Trials” Added To FDA Draft Guidance On Master Protocols; Update Is Packaged As Part Of “TrialBlazer” Initiative As Agency Continues To Encourage Use Of MPs

Advisory Committee Tracker: FDA Promises More Meetings To Rare Disease Advocates, But Nothing On The Agenda; Will Makary-Era Reversals Go To Panel?

Prevision Policy Clips | FDA Commissioner Search: White House Policy Staffer Heidi Overton Is One Candidate

Oncology Center Of Excellence Under De Claro: 2025 Report Praises “Institutional Resilience” Of OCE, Includes Roster Of “Project” Leadership

“Act For ALS” Appears Primed For Reauthorization By Congress; “ALL ALS” Research Collaboration Keeping Issue Front And Center

Prevision Policy Clips | FDA Appropriations Still Stalled In Senate

FDA “Expedited IND” Pilot Will Feature Rolling Submissions, Third-Party “QRIs” To Help Guide Trial Protocols

FDA Single-Trial “Default” Policy Spelled Out In Updated “Substantial Evidence” Draft Guidance; Focus On Current Statutes And Recent Precedent, Not FD&C Act History

Moderna mFlusiva Launch In 2026 Will Hinge On Labeling Discussions, Strain Update After Unanimous FDA Advisory Committee Votes: Smooth End After Controversial Start To BLA

Trump’s Global Rx Pricing Push: HHS’ Klomp Touts UK Commitment To Double New Medicine Spending As Model For MFN Deals With Other Countries

Prevision Policy Clips | Moderna Flu Vaccine Breezes Through VRBPAC

RTOR Tracker: Most 2025 Approvals Occurred Within Two Weeks Of Goal Date; Are Workload Strains Affecting Timelines?

Sanofi’s Tzield CNPV Memo: Acting CDER Director Davis Stands By Review Team On Approving sBLA; Neither Sponsor Nor Division Requested Voucher

Senate HELP Committee Advances Incremental Drug Price/Competition Bills; Sanders’ International Reference Pricing Amendment Rejected, But Insulin Act Adopted

Is There A Future For CNPV? Any Modifications Should Balance Accelerated Review Against Ensuring “Public Trust,” Industry Execs Say

Prevision Policy Clips | Senate HELP Advances Two Drug Pricing Bills, “ACT For ALS”

Prevision Policy Clips | UniQure Huntington’s Gene Therapy Back On Track For Accelerated Approval Filing

Senate Democratic Drug Pricing Proposals Cast Wide Net: Incentives For Small Biotech Among Biomedical Innovation Proposals; Ideas Like GLP-1 Subscription Model Could Become Bipartisan

Moderna mFlusiva mRNA-Based Flu Vaccine: VRBPAC Will Vote Separately On Use In 50-64 And 65+ Populations; FDA Sees Superior Efficacy In Younger Group

Prevision Policy Clips | Colorado Rx Import Plan Conditionally Approved By FDA

CMS Medicare Price Negotiation Rule Would Close SubQ Biologics “Loophole”; Implementing Regulations Reaffirm IRA Policies As Largely Settled Going Forward

Prevision Policy Clips | Medicare Price Negotiation Draft Rule Released: SubQ Biologics Would Not Be Separately Negotiated

Takeda Oveporexton Narcolepsy Agent Viewed As Superior To Other Therapies By ICER Panel; Price Of $50,000/Year Would Be Cost Effective, Group Says

Prevision Policy Clips | HRSA Plans To Revive 340B Rebate Model Pilot Program

FDA Encouraging “Patient-Centric” Dosage Forms For Generic Drugs; Workshop Highlights Suitability Petitions As Route To Enable Easier-To-Swallow Formulations