Genentech’s Tecentriq For Triple Negative Breast Cancer: FDA Seems Open For Different Confirmatory Study; Will Advisory Committee Agree?

Prevision Policy Clips | FDA Publishes Antisense Oligonucleuotide Nonclinical Testing Guidance

“FDA-Agreed” Warning Ready For J&J COVID-19 Vaccine Restart; ACIP Is Satisfied With Enhanced Surveillance, Rarity Of TTS Events

ODAC Will Deliver Straight Yes/No Vote On Whether Six Accelerated Approvals Can Be Preserved; FDA Also Requesting Advice On Additional Studies

Prevision Policy Clips | CMS Nominee Brooks-LaSure, HHS Deputy Palm Clear Finance Committee, But Tie Vote On CMS

CAR-Ts For Multiple Myeloma Show Net Health Benefit, ICER Panel Says, But Dubious Value For The Price; GSK’s Blenrep Is Priced In Line With QALY Benefit, But Panel Still Doubts Value

FDA Takes Firm Stance On “Dangling” Accelerated Approvals Ahead Of ODAC But Offers Opening For Alternatives To Withdrawal

Prevision Policy Clips | FDA Schedules Workshop On MIDD For Immunogenicity Assessments: June 9

FDA’s Woodcock Looks Ahead To Next Pandemic: Clinical Trial Enterprise Has A “Golden Opportunity” To “Do Better” – Especially On Therapeutics

Prevision Policy Clips | House Republicans Reintroduce Drug Pricing Alternative As “Lower Costs, More Cures” Legislation

Prevision Policy Clips | ODAC Accelerated Approval Review: Six Conflict-of-Interest Waivers Granted

FDA Cell Therapy Committee Votes Favorably On CellTrans Islets For Type 1 Diabetes For Small Patient Group; CMC Issues Discussed By Split Committee

Prevision Policy Clips | ICER Accelerated Approval White Paper Coming in Next Couple of Weeks

NCI NCORP Network Is Extending Oncology Research Into Community Setting, Sharpless Says: Potential Model For Other Therapeutic Classes

Prevision Policy Clips | New Molecular Entity Definition Changed In Legislation Sent To President Biden April 15

“ARPA-H” Translational Science Mission Questioned During House HHS Budget Hearing: Does New NIH Project Overlap With NCATS?

HHS Deputy, CMS Administrator Nominees Breeze Through Confirmation Hearing; Biden Drug Pricing Agenda Remains Undefined

Prevision Policy Clips | FDA “Current Thinking” On J&J COVID Vaccine: More Warnings In EUA Fact Sheet

FDA’s Woodcock Counters Speculation On “More Stringent” Standards; Calls For New Centers Of Excellence Should Go On Back Burner Due To Staff “Stress”

FDA Outlines Remote Inspection Program In New Guidance: Sponsors May Not Request Them And May Decline Them – If They Don’t Mind Approval Delays

Learning From COVID: OCE Outlines Research Agenda To Assess Impact Of Trial Modifications; Sponsors Asked To Flag All “Remote” Elements In Submissions

CellTrans’ Type 1 Diabetes Therapy Likely Needs CMC Work For Approval; FDA Sees Benefit But Asks Committee To Help Better Define Patient Population

Prevision Policy Clips | HHS Budget Hearing April 15 Will Feature Secretary Becerra

Medicaid Rebates To Enforce Accelerated Approval? New Idea For Congressional Debate; MedPAC Endorses Policies For Vaccines, Separately Payable Drugs

J&J COVID-19 Vaccine “Rare And Severe” Blood Clots Are Similar To Those Seen With AstraZeneca, FDA Says; Vaccination “Pause” Will Be Relatively Brief