Pfizer/Lilly’s Tanezumab Rejected By FDA Advisory Committee Due To Joint Risk: Is There A Revamped REMS That Might Save The BLA – And The Class?

Prevision Policy Clips | FDA Arthritis Advisory Committee Will Hold May 6 Meeting For ChemoCentryx’ Avacopan

International Reference Pricing, Medicare Negotiation Are Themes At Sanders Drug Pricing Hearing; Pelosi Says HR3 Should Be In Infrastructure Package

Prevision Policy Clips | House Speaker Pelosi Says “Aspects” Of HR3 Drug Pricing Bill Could Be In Infrastructure Package

FDA Principal Deputy Abernethy’s Departure Leaves Need For Conduit To Digital Community; Exit Adds To Era Of Change

Prevision Policy Clips | AstraZeneca Review Of COVID Vaccine Primary Efficacy Analysis Underway Following DSMB Concerns

Pfizer/Lilly Tanezumab Prospects In Osteoarthritis Shaky Ahead Of Committee Review; FDA Appears Unconvinced Proposed REMS Can Address Joint Risk

Prevision Policy Clips | AstraZeneca Plans FDA EUA Submission “In The Coming Weeks” For Coronavirus Vaccine

FDA Rare Disease Center of Excellence Proposed In New Bill (STAT Act); Provisions Include FDA-Led Payor Feedback Program For Drug Developers

Prevision Policy Clips | Regulatory “SUNSET” Rule Formally Delayed By HHS

Long-Term COVID Response Is Key Theme At Senate Health Hearing: Outlook For Vaccine Boosters And Pricing, Need For Therapeutics – And Return Of David Kessler

RWE Trials Could Be Used In Community Setting, FDA's Woodcock Says; Burden Of COVID-19 On Product Reviews Has Been “Tremendous”

Prevision Policy Clips | HHS Secretary Nominee Becerra Set For Confirmation Vote Today; Will Woodcock Nomination Follow?

FDA Takes Backseat In COVID Response Hearing: CBER Director Marks Faces Few Questions; Says US Vaccine Supply May Support Boosters

Ex-FDA Commissioners Call For More Active Government Role In Emergency Drug Development: Directing Patients To Preferred Projects

Fast-Acting Antidepressants Will Benefit From New Patient-Reported Outcome Tools; FDA’s Farchione Explains Spravato, Zulresso Reviews, Sees Exciting Time In Psychiatric Drug Development

Prevision Policy Clips | “Protected Classes” Win Again: CMS Revises Part D “Payment Modernization Model”

Prevision Policy Clips | Purdue Bankruptcy Plan: New Public Benefit Corporation Would Sell Opioid Treatments “At Or Below Cost”

Prevision Policy Clips | Medicare Coverage Final Rule Defining “Reasonable And Necessary” Has Effective Date Delayed Until May 15

Prevision Policy Clips | HHS Assistant Secretary For Legislative Affairs Nominee Egorin Is House Ways & Means Deputy Health Staff Director

Vitiligo Patients Favor Easy-To-Use, At-Home Treatments; Face Is Most Important Area For Treatment, FDA Patient-Focused Drug Development Meeting Concludes

Oncology Accelerated Approval "Industry-Wide Review": Can Pazdur – Or ODAC – Find Alternatives To Formal Withdrawal?

Prevision Policy Clips | Oncology Accelerated Approval Reviews: ODAC Will Review Keytruda, Opdivo And Tecentriq Indications

Prevision Policy Clips | CBER Director Marks, NIAID Director Fauci To Testify On COVID-19 Vaccination Efforts March 17

Foreign Inspections: FDA Has Tough Day In Absentia During House Appropriations Hearing; GAO Raises Grade To “C” – From “F” Two Decades Ago