Regulatory Focus™ > News Articles > 2022 > 5 > Recon: Teva, Allergan reach $161.5M opioid settlement with W. Virginia; Pfizer pledges to sell drugs

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Posted 25 May 2022 | By Michael Mezher 

Recon: Teva, Allergan reach $161.5M opioid settlement with W. Virginia; Pfizer pledges to sell drugs at no profit in low-income countries

2797 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Teva, Allergan reach $161.5 million opioid settlement with West Virginia (Reuters)
  • CVS Will Stop Filling Controlled-Substance Prescriptions for Cerebral, Done (WSJ)
  • 'Hands may be tied': FDA slaps Verrica with 3rd CRL due to problems with contract manufacturer (Endpoints)
  • GSK 'schemed' FDA's drug-device approval pathway to deflect asthma inhaler generics, lawsuit claims (Fierce)
  • Whistleblower report on baby formula didn’t reach top FDA food safety official (Washington Post)
In Focus: International
  • Pfizer to sell all its patented drugs at nonprofit price in low-income countries (Reuters) (STAT)
  • G20 pandemic fund ploughs ahead amid fears world not ready for future threats (Reuters)
  • WHO member states agree to fix 'rotten' funding model (Reuters)
  • French health body backs new COVID vaccine booster campaign for this autumn (Reuters)
  • Bavarian Nordic raises sales guidance after monkeypox vaccine order (Reuters)
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  • AstraZeneca reviews diversity in trials to ensure drugs work for all (The Guardian)
  • EU Tracking CTR Impact On Clinical Trials Environment (Pink Sheet)
Pharma & Biotech
  • Explainer: What vaccines, treatments do we have to combat monkeypox? (Reuters)
  • GSK avoids strike as UK workers accept pay negotiation (Endpoints)
  • Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation (Endpoints)
  • Life sciences developer BioMed Realty buys San Francisco hotel for $75M — report (Endpoints)
  • New kind of off-the-shelf cancer vaccine reduces metastasis in animal experiments (STAT)
  • Cracks in the facade: Is pharma's pandemic ‘feel good factor’ waning? (Endpoints)
  • Surprise US FDA Facility Inspections Resume In India (Pink Sheet)
  • Closed-Loop Inspections? Strict COVID Zero Policy Delays FDA's China Field Trips (Pink Sheet)
  • Are Trial Sponsors Treading On Investigators’ Toes In Decentralized Trials? (Pink Sheet)
  • FDA starts clock on review of CSL, UniQure gene therapy (BioPharmaDive)
  • Taking another shot at mRNA glory, CureVac inks oncology pact while keeping up with Covid work (Endpoints)
  • While down 87% YOY, Evelo gets Flagship and others to infuse new capital for comeback hope (Endpoints)
  • Antios' HBV collab axed after clinical hold, but biotech believes safety incident is not treatment-related (Endpoints)
  • Former Principia team looks to shake up covalent small molecules again, this time at 'earthquake' scale (Endpoints)
Medtech
  • Verily advances smartwatch toward Parkinson’s clinical trial use after validating technology (MedtechDive)
  • RapidAI speeds up pulmonary embolism diagnosis with FDA clearance for AI triage tool (Fierce)
  • Multiomics startup Pleno nabs $15M for a telecom-based approach to analyzing DNA, RNA (Fierce)
Government, Regulatory & Legal
  • Moderna seeks to dismiss Alnylam suit over Covid-19 vaccine component, claiming wrong venue (Endpoints)
  • Bristol Myers Squibb sues Novartis for royalties surrounding the use of transgenic mice (Endpoints)
  • Mylan Hit With Infringement Suit Over MS Generic Drug (Law360)
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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