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

ReconRecon | 05 May 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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