Pfizer Troxyca Gets Close “Yes” Vote on Approval, Support For Some ADF Claims; FDA Panel Wary Of Adding Opioids

REMS “Platform” Development: “Business Case”—Not Technical Hurdles—Will Be Primary Barrier, Stakeholders Say

Teva’s Vantrela Panel Vote For Three ADF Claims Would Put It On Par With Hysingla, Likely Spells A Winding Down of Zohydro

Merck C. Diff. Antibody Heads To FDA Committee: “Prevention of Recurrence” Claim Treated Skeptically By Agency Reviewers

Sarepta Approval Prospects Look Much Brighter After FDA Info Request; Non-CR Approach Means Accelerated Approval Likely

Pfizer’s Troxyca: FDA Review Suggests Some Favorable Abuse-Deterrent Studies, But Is Formulation Enough?

Teva’s Vantrela ER: FDA Ready to Approve With Abuse-Deterrent Claim; Panel To Revisit Long-Acting Hydrocodone 4.5 Years After Zohydro

Weekly Highlights: May 31-June 3

ICER Meeting on Multiple Myeloma Drugs Features Evolving Efficacy Profiles, Payor Reluctance To Restrict; MS Review Delayed

FDA Finalizes Expanded Access Guidances and Streamlined Form: Broad Response to “Right-to-Try,” Not Just Sarepta

Transdermal Patch Rating System For Generic Adhesion Tests: FDA Sticks With Five-Point Scale In Draft Guidance

Woodcock Goes to School On Bayesian Methods: Antibiotic Experience Suggests New Push In Drugs For Small Populations

Weekly Highlights: May 20-27

House GOP Drafts New Off-Label Policy In Effort To Shake Loose FDA Guidance: “Proactive/Reactive” Speech Protected

FDA Advisory Committee Tracker: Sugar and Spice? Diabetes Outcomes, Opioid Formulations Dominate Upcoming Panel Topics

Sanofi iGlarLixi Diabetes Combo Earns Strong Approval Vote From FDA Committee; Pen Injector Remains Problem

FDA’s Next Wave Of Off-Label Enforcement Will Avoid Free Speech Defenses; Patients Harmed By Use May Be One Option

LifeBOAT Bill Proposes Opioid Excise Tax to Fund Addiction Treatment, Would Raise Up to $2 Bil. Per Year

Novo Nordisk Xultophy Combo Clears Committee, With Support For Relatively Broad Label; Sanofi Likely To Have Similar Result

Sanofi May Benefit By Going After Novo at FDA Panel With iGlarLixi; Lixisenatide Solo Appears Headed To Tepid “Yes”

FDA’s Moscicki Says Patient Input Must Be Balanced; Suggests Compliance Has Overtaken “Judgment” In AE Safety Reports

Novo Xultophy Faces Tough Review; FDA Wants Discussion Of Role Of GLP-1/Insulin Combo Before Settling On Pathway

FDA Center of Excellence Proposal Threatens Some CBER “Boutique” Strengths: Manufacturing, Dialogue With Sponsors

Glass Half Full? Failed Senate Approps Amendment On Vial Size Issue Would Bring FDA Into Drug Pricing Debate

Diabetes Outcomes Redefined? FDA Wants Input On Endpoints Beyond HbA1c, May Revisit CV Study Requirements