Recon: Purdue’s Sacklers Reaches Terms of $6 Billion Opioid Settlement with States; Biogen begins friendly layoffs

Posted on March 03, 2022 | By Joanne S. Eglovitch

Welcome to Regulatory Reconnaissance, your daily update on regulatory news and intelligence.

In brief: United States

  • Purdue Sacklers Reach $6 Billion Opioid Settlement With States (Bloomberg) (Law360)
  • FDA begins court-mandated release of thousands of pages of Pfizer’s Covid-19 vaccine review (Endpoints)
  • Rejecting Eli Lilly’s motion, the federal judge returns to justice a whistleblower case that has been going on for years (Endpoints)
  • The U.S. FDA’s biological research oversight program increasingly relies on remote assessment tools (The pink leaf)
  • Civica aims to launch low-cost insulin in the United States by 2024 (Reuters) (STAT)
  • HHS Inspector General to Review Use of Biosimilars in Medicare Part B (Biopharmaceutical Journalist)
  • Biden’s ‘Test to Treat’ plan will include COVID pills from Merck and Pfizer, but only one gets public thanks (The pink leaf)
  • US health agencies request data on COVID misinformation (Reuters)

Focus: International

  • Drugmakers and device makers say the sanctions could hamper medical supplies in Russia (Reuters)
  • Illumina’s remedies on Holy Grail offer are unconvincing to EU antitrust regulators, sources say (Reuters)
  • The United States will share certain coronavirus technologies with the World Health Organization (Washington Post)
  • Wuxi STA Site Passes EMA Pharmaceuticals Pre-Approval Inspection (Biopharmaceutical Journalist)
  • EMA says not concerned about New York state data on Pfizer/BioNTech vaccine (Reuters)
  • WHO approves molnupiravir as treatment for Covid-19, after new data from India (Endpoints)
  • Russia’s war in Ukraine is now delaying the reading of the data, as Tricida says its second-chance trial needs more time (Endpoints)
  • Roche steps up free supply of antibiotics to Ukraine as drug donations start pouring in (Endpoints)
  • Pfizer to Provide 10 Million Courses of COVID Pills to Developing Countries – The Global Fund (Reuters)
  • WHO sees little impact on COVID-19 vaccine supply in Africa from war in Ukraine (Reuters)

Coronavirus pandemic

  • Omicron much deadlier than the flu shows risks of relief too soon (Bloomberg)
  • Facing omicron ‘curveball’, Inovio looks for an endpoint change in fear that it will hit against the original target (Fierce)
  • An arthritis drug has been shown to reduce the risk of death from COVID in a large UK trial (Reuters)

Pharmaceuticals and biotechnology

  • With Aduhelm in limbo, Biogen begins laying off employees (STAT) (Diving BioPharma)
  • Novo Nordisk more than doubled its obesity drug sales target (Reuters)
  • While awaiting “definitive” data on drugs for Alzheimer’s disease, Roche and Genentech are launching an ambitious new study (STAT)
  • GCP Inspections: Corrective Actions for Adverse Results Must Be Tested, Says US FDA (The pink leaf)
  • Sterling bolsters its API capability with a large purchase of the Novartis campus in Ireland (Endpoints)
  • Atlas lands $450 million fund to build new biotech batch (Fierce)
  • AstraZeneca and Sanofi reveal a mixed hand in the high-stakes RSV game, with a missed hospitalization tarnishing the main end result (Fierce)
  • Avalo adjusts pipeline almost weekly after CEO and CFO say sayonara (Fierce)
  • Organoids reveal the tipping point when kidney damage becomes irreversible (STAT)
  • The Spanish industry is asking for a dedicated channel for the reimbursement of orphan drugs (The pink leaf)

medical technology

Government, regulation and legal

  • Regeneron cannot abandon the COVID-19 technology patent suit (Law360)
  • Cook Blood-Clot Filter Injury Suit Too Late Despite Fraud Allegations (Bloomberg)
  • Walgreens stops lawsuit under Texas pharmacist misrepresentation law (Bloomberg)
  • Pinched pharmacies are lobbying the FTC for action on drug costs (Bloomberg)

Regulatory Recon is our daily intelligence briefing for regulatory affairs, bringing you top regulatory, biopharma and medtech news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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