Advisory Committee Tracker: GSK Trelegy Mortality Claim Highlights Trio Of Newly Announced Reviews

Lilly Cyramza First-Line Lung Cancer Claim Narrowly Clears Committee; The Long Shadow Of Avastin Lingers – But Lilly’s Reputation May Help Garner Approval

Rare Disease Center Of Excellence Pushed By EveryLife: FDA Has Authority But Congress Being Asked To Weigh In; Possible “Cures 2.0” Theme

Prevision Policy Clips | Drug Importation Proposed Rule: HHS Secretary Azar Welcomes Legislative Fix For Insulin

Steba’s Tookad For Early-Stage Prostate Cancer Shot Down By FDA Advisory Committee; Confirmatory Trial Results Expected In 2030

Gene Therapies For Rare Diseases: Strong Natural History Studies And N-Of-Some Trials Headline Meeting; FDA Commissioner Hahn Makes A Debut

Prevision Policy Clips | Gilead Remdesivir Randomized Trial Results Expected “Reasonably Soon”

Drug Pricing Takes Back Seat To Coronavirus In Latest HHS Budget Hearing; Debate On Overseas API, Shortages Could Have Longer-Term Impact on Pharma

Prevision Policy Clips | ODAC Reviews Will Test Accelerated Approval, Show Expectations For PFS v. Survival In First Line Lung Cancer

Steba Takes Tookad To FDA Committee For Early Prostate Cancer: Novel “Prevent/Delay” Endpoint Will Test Accelerated Approval Parameters

Lilly Cyramza First-Line Lung Cancer Claim: FDA Review Suggests Survival Benefit Needed For Approval – But Strong PFS May Work One Last Time

Hahn’s FDA Prepares For “Deeming Day”: NDA-BLA Transition Marks Early Milestone In New Commissioner’s Tenure

Prevision Policy Clips | FDA Rare Disease Division Leadership Still Unsettled Following Departure Of Dragos Roman

Prevision Policy Clips | FDA “Class Of 2019” NME Profile: Seven Products Were Approved Based On US-Only Trials

FDA’s “Technology Modernization Action Plan” Moves To First Tangible Projects; Streamlined IND Safety Reporting Is An Early “Living Example”

FDA Guide To Pharmacogenomic Tests Includes Three “Unapproved” Drug Claims; Effort To Guide Consumers Underscores Gaps In Regulatory Framework

FDA Protein Definition Retains “Bright Line” At 40 Amino Acids; New Rule Takes Effect In Time For BLA Deeming Day

Prevision Policy Clips | FDA Finalizes New Definition Of Biologics: “Bright Line” At 40 Amino Acids

HHS Inspector General Studying Use Of “High-Expenditure” Medicare Drugs For Orphan Indications; Report Due In 2021

Prevision Policy Clips | GSK’s Trelegy Survival Benefit Claim Will Be Reviewed By FDA Advisory Committee April 21

Prevision Policy Clips | CBER CAR-T and Genome Editing Guidances Among Next Projects

Prevision Policy Clips | Belviq Obesity Drug To Be Withdrawn, Just The Beginning For FDA?

WAC Inflation Penalty Has Strong Support From HHS Secretary; Not “Price Control,” Would Improve Incentives In Supply Chain, Azar Says

NIH Has Big Objectives In Gene Therapy Production, But Short-Term Focus Likely On Incremental Funding To Expand AAV Facilities

Prevision Policy Clips | OND Reorg: Still Waiting For Phase IV

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