Prevision Policy Clips | J&J COVID-19 Vaccine Subject Of Emergency ACIP Meeting April 14 After "Pause" In Vaccinations

Oncology Clinical Trial Eligibility Expansion A Focus For FDA, With More Guidance Coming; Sponsors Are Overcoming Initial Hesitation

CDER Leadership Change Is Official: Cavazzoni No Longer “Acting” As Director; Delicate Time For Drug Center Post-COVID

White House Keeps Drug Pricing Cards Close To The Vest In Budget Request; ARPA-H And "Cures" Act Prioritized; FDA Out Of Spotlight

Prevision Policy Clips | ARPA-H Gets High Profile But No Independence In Biden Budget: $6.5 Billion

CBO Report On Pharma R&D Paints Favorable Portrait Ahead Of Pricing Debate; Impact Of Adverse Policies On Innovation Is Still In The Eye Of The Beholder

Prevision Policy Clips | CBO Pharma R&D Profile Provides Timely Snapshot

CBO Public Option Report And Drug Prices: Negotiating Leverage Is King

Prevision Policy Clips | ICER To Review MyoKardia/Bristol Myers Squibb’s Mavacamten For Hypertrophic Cardiomyopathy

Prevision Policy Clips | FibroGen Roxadustat Advisory Committee Review Tentatively Set For July 15; Safety Data Snafu

180-Day Exclusivity For First Generics Could Be At Risk As Result Of Pandemic Inspection Challenges, FDA Warns In New Guidance

Prevision Policy Clips | RMAT Designation Requests Trending Up In 2021: New Data Posted

Advisory Committee Tracker: Accelerated Approval Review Will Highlight April Agenda; Application Reviews Slowly Returning To Calendar

Prevision Policy Clips | FDA Will Review EUA Process As One Of First Pandemic “Lessons Learned” Priorities

FDA Weighing Options to Better Understand How Drugs Work in Older Adults: Working Group Likely Starting Point, New Incentives Not The Immediate Focus

ICER Review Of Lupus Nephritis Therapies: Aurinia Criticized For Dosing Strategy Patent That May Get More Attention; Benlysta And Lupkynis Are In ICER Range

Prevision Policy Clips | Democratic Opposition To Janet Woodcock As FDA Commissioner Grows

FDA Oncology Center “Project Catalyst” Debuts: Drug Regulation 101 Event Showcases Collaborative FDA – And Its Limits

Prevision Policy Clips | Drug Pricing Part Of Second Infrastructure Plan, White House Chief Of Staff Ron Klain Confirms

Prevision Policy Clips | Biotech R&D, Pandemic Preparedness Among Items To Be Supported In Biden Jobs Bill

Simplifying Randomized Trials: RECOVERY Shows Value Of Pragmatic Studies; Mars-Shot Approach Building On Existing Trial Networks Could Speed US Toward Similar Effort

Prevision Policy Clips | Merck Will Discuss “Next Steps” With FDA After CRL For Keytruda

Prevision Policy Clips | FDA Commissioner Search: White House Press Corps Takes Note

HARPA Health Research Projects Agency Anointment Likely In Biden Budget; New Agency Would Bring DARPA Culture To Projects Stalled By Market Failures

Prevision Policy Clips | GlaxoSmithKline/Vir Plan To File For Emergency Use Authorization For “Dual-Action” Coronavirus Monoclonal Antibody