Recon: Congress considers accelerated approval reforms in user fee bill; Quality concerns prompt Novartis to stop manufacturing cancer therapies at two sites

• Congress mulls softer accelerated approval reforms as part of user fee reauthorizations (Endpoints) (The Pink Sheet) (STAT)
• Enhertu wins another breast cancer approval, as AstraZeneca and Daiichi Sankyo prepare to corner the market (Endpoints) (Biospace)
• BioCryst officially gets partial clinical hold on lead candidate after halting enrollment (Endpoints)
• FDA to create training program to inspect more mRNA vaccine manufacturing (Endpoints)
• OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule (The Pink Sheet)
• ctDNA Can Be Used For Patient Selection and Enrichment, But Not As Early Efficacy Endpoint, US FDA Says (The Pink Sheet)
• Axsome Is Latest To Falter With Technology For Unlocking Meloxicam’s Analgesic Potential (The Pink Sheet)
• Duke’s Klotman is under consideration as the next NIH head (Washington Post)

• WHO members to consider shutting Europe hub office in Russia over Ukraine – document (Reuters)
• EU regulator hopes to approve COVID variant-adapted vaccines by autumn (Reuters)
• Novavax files for authorization of COVID-19 shot among adolescents in Britain (Reuters)
• EMA Bigs Up Patient Data & ‘Real-World Experience’ (The Pink Sheet)
• Third Ebola case confirmed in northwest Congo, WHO says (Reuters)
• PRIME Dry Spell Over As EMA Says Yes To Pfizer & BioCryst (Pink Sheet)
• Covid Killed One Out of Every 500 People, WHO Report Shows (Bloomberg) (STAT) (Washington Post)
• Bavarian Nordic’s COVID-19 vaccine holds up against omicron in phase 2, fueling pivotal booster push (Fierce)

• Novartis suspends two cancer therapies over quality concerns (Reuters) (Endpoints)
• AstraZeneca’s Heart Disease Drug Delivers Key Endpoints in Phase III (Biospace)
• Jazz flexes deal chops, paying Sumitomo $50M for ex-Asia rights to early-phase narcolepsy prospect (Fierce)
• In wake of Biogen's skirmish with the SEC, pharma giants are changing the way they do quarterly reports (Endpoints)
• Shrinking BridgeBio confirms layoffs, details out-licensing plans for its ‘restructuring initiative’ (Endpoints)
• Under Scrutiny. Some Telehealth Firms Are Rethinking ADHD Drugs (Bloomberg)
• Study uncovers clues to rise in uterine cancer death rates (STAT)

• FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program (Medtech Insight)
• FDA’s Shuren On Why Agency Broke Up Its IVD And Radiological Health Office (Medtech Insight)
• FDA reveals another Class I COVID-19 test recall as SML pulls 209,000 kits from the market (Medtech Dive)
• FDA clears Abbott’s 4-in-1 Alinity PCR test for sexually transmitted infections (Medtech Dive)

• McKesson Whistleblower’s Cancer Drug Kickback Suit Dismissed (Bloomberg)
• J&J sues company over alleged abuse of its cost assistance program (Endpoints)
• Eargo To Pay $34M+ To Resolve False-Claims Allegations (MedTech Insight)
• Walgreens reaches $683 mln opioid settlement with Florida (Reuters)