Insmed Inhaled Antibiotic Advisory Committee Centers On Strength Of Surrogate Endpoint: FDA Looking At Non-RCT Supportive Data; Seeks Outside Confirmation

Prevision Policy Clips | CMS Gives Matching Add-On Payments for Novartis/Gilead CAR-Ts

Novartis and Gilead CAR-Ts Get Add-On Payments, But New DRG Model Deferred; CMS Also More Amenable To New Antibiotics

Prevision Policy Clips | ICER to Review Spinal Muscular Atrophy Treatments In March 2019

TIRF Wars: REMS For IR Transmucosal Fentanyl May Not Be A Model After All; Concerns Remain On Patient Selection

Prevision Policy Clips | Advancing Pediatric Pharmacovigilance Workshop September 14

FDA Looks To Expand Scope Of Sentinel Data By Adopting Machine Learning Practices To Paper/PDF Health Records

Advisory Committee Tracker: So Many Approvals, So Few Advisory Committees

FDA Seeking More Real-World Evidence Proposals From Sponsors; Ad Hoc Projects Precede General Guidances

Prevision Policy Clips | NDA User Fee Increases To $2.59 Million For Fiscal 2019

Prevision Policy Clips | FDA Biosimilar Fee Notice Hints At Surge In Approvals

Prevision Policy Clips | 60 Degrees Pharma Tafenoquine for Malaria Prophylaxis Gets Positive Advisory Committee Recommendation

60 Degrees Pharma Tafenoquine for Malaria Prophylaxis Likely To Follow GSK’s Treatment Version To Market Soon, Following Positive Advisory Committee

340B Cuts Will Expand In 2019 Under Proposed Rule; Exparel Doing Fine In Bundle, CMS Says – But Will Be Carved Out In ASCs

Part B Competitive Bidding Demo Floated: Re-Inventing CAP As “VAPA” – With Value Focus, Potential Inclusion of Medicaid

GSK Nucala For COPD Turned Down By FDA Advisory Committee; Phase III Trials Undercut By Trying To Do Too Much

Prevision Policy Clips | CMS Seeks Ideas For Reviving Competitive Bidding Program In Part B, Proposes To Expand 340B Payment Cut

New Focus For FDA Competition Efforts: Incentives For Second And Third Entrants In Specialty Drug Classes; “Cures” Hearing Testimony Shifts Focus From Unmet Need

Biologics Patent Settlement Reporting Provision Added To Pharmacy “Gag Clause” Bill Heading To Senate Floor

CMS Policy On “Indication-Based Utilization Management” Points Towards Indication-Based Pricing – And Shows More Activist Pricing Tone At Medicare Agency

Prevision Policy Clips | CMS Staffs Up: New Principal Deputy Paul Mango

FDA Biosimilars Hearing In September Seeks To Flesh Out Ideas In Action Plan; Evergreening And “Umbrella Exclusivity” Among Key Topics

Prevision Policy Clips | FDA Sets Part 15 Hearing Date For Ideas To Enhance Biosimilar Competition

GSK Nucala COPD Indication Lacks Replicated Trial Support and Is Based On Unconfirmed Mechanism Of Action, FDA Says In Advisory Committee Preview

Prevision Policy Clips | GSK’s Tafenoquine Approved; 60 Degrees Pharma’s Product To Adcomm This Week