Recon: Purdue’s Sacklers reach terms on $6B opioid settlement with states; Biogen begins layoffs amid sluggish sales of Aduhelm

ReconRecon | 03 March 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Purdue’s Sacklers Reach $6 Billion Opioid Settlement With States (Bloomberg) (Law360)
  • FDA begins court-mandated release of thousands of pages on Pfizer's Covid-19 vaccine review (Endpoints)
  • Pushing back against Eli Lilly motion, federal judge sends years-long whistleblower case to trial (Endpoints)
  • US FDA Bioresearch Monitoring Program’s Reliance On Remote Assessment Tools Grows (The Pink Sheet)
  • Civica aims to launch low-cost insulin in US by 2024 (Reuters) (STAT)
  • HHS Inspector General to examine biosimilars use in Medicare Part B (BioPharma Reporter)
  • Biden’s ‘Test To Treat’ Plan Will Include Merck And Pfizer COVID Pills, But Only One Gets Public Thanks (The Pink Sheet)
  • U.S. healthcare agencies request data on COVID misinformation (Reuters)
In Focus: International
  • Drugmakers, device companies say sanctions may hinder medical supplies to Russia (Reuters)
  • Illumina remedies on Grail bid unconvincing to EU antitrust regulators, sources say (Reuters)
  • US to share some coronavirus technologies with World Health Organization (Washington Post)
  • Wuxi STA site passes EMA drug product pre-approval inspection (BioPharma Reporter)
  • EMA says not concerned by New York state data on Pfizer/BioNTech vaccine (Reuters)
  • WHO OKs molnupiravir as treatment for Covid-19, after new data from India (Endpoints)
  • Russia's war in Ukraine is now delaying data readouts, as Tricida says its second-chance trial needs more time (Endpoints)
  • Roche steps up with a free supply of antibiotics for Ukraine as drug donations begin to flow (Endpoints)
  • Pfizer to provide 10 mln courses of COVID pill to developing countries -the Global Fund (Reuters)
  • WHO sees little impact on COVID-19 vaccine supplies to Africa from Ukraine war (Reuters)
Coronavirus Pandemic
  • Omicron Much Deadlier Than Flu Shows Risks of Easing Too Soon (Bloomberg)
  • Facing omicron ‘curveball,’ Inovio seeks endpoint switch amid fear it will strike out against original goal (Fierce)
  • Arthritis drug shown to reduce risk of COVID death in large UK trial (Reuters)
Pharma & Biotech
  • With Aduhelm in limbo, Biogen starts laying off employees (STAT) (BioPharma Dive)
  • Novo Nordisk more than doubles sales target for obesity drugs (Reuters)
  • Awaiting ‘definitive’ Alzheimer’s drug data, Roche and Genentech launch ambitious new study (STAT)
  • GCP Inspections: Corrective Measures For Adverse Findings Should Be Tested, US FDA Says (The Pink Sheet)
  • Sterling builds up its API capacity with big buy of Novartis campus in Ireland (Endpoints)
  • Atlas lands $450M fund to build fresh batch of biotechs (Fierce)
  • AstraZeneca, Sanofi reveal mixed hand in high-stakes RSV game, with hospitalization miss tarnishing primary endpoint hit (Fierce)
  • Avalo adjusts almost entire pipeline weeks after CEO, CFO say sayonara (Fierce)
  • Organoids reveal the tipping point when kidney damage turns irreversible (STAT)
  • Spanish Industry Calls For Dedicated Orphan Drug Reimbursement Route (The Pink Sheet)
  • EMA Takes Over Permanent Secretariat For Medical Device And IVD Expert Panels (MedTech Insight)
  • 75% of infusion pumps have cyber flaws, putting them at risk from hackers: study (MedTech Dive)
  • Dexcom Works With FDA To Bring CGM To Hospitals After Pandemic (MedTech Insight)
Government, Regulatory & Legal
  • Regeneron Can’t Ditch COVID-19 Tech Patent Suit (Law360)
  • Cook Blood-Clot Filter Injury Suit Too Late Despite Fraud Claims (Bloomberg)
  • Walgreens Stops Texas Pharmacist’s False Claims Act Suit (Bloomberg)
  • Pinched Pharmacies Pressure FTC to Take Action on Drug Costs (Bloomberg)
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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