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October 3, 2024
by Jason Scott

Recon: Texas AG sues insulin makers, PBMs over high costs; Lilly resolves US weight-loss drug shortages

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Dockworker strike puts drug supplies at risk (STAT)
  • Texas attorney general sues insulin makers and pharmacy middlemen over high costs (Reuters)
  • Epic and Particle dragged a nonprofit into their antitrust fight. Here’s what you need to know (STAT)
  • Lilly's weight-loss drug removed from FDA's shortage list (Reuters) (Endpoints)
  • FDA lifts partial hold on Avidity’s myotonic dystrophy drug; Orum's IPO in South Korea (Endpoints)
  • For next round of IRA price negotiations, US says it will meet with companies sooner (Endpoints)
  • Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence (Pink Sheet)
  • US Medicare issues updated rules for second round of drug negotiations (Reuters)
  • Gilead signs deals with 6 generic drugmakers to sell HIV drug in low-income countries (Reuters)
In Focus: International                                                                                                       
  • Flagship partners with key Singapore R&D agency as it boosts APAC investment (Endpoints)
  • Investor Kurma Partners raises €140M for latest Europe-focused biotech fund (Endpoints)
  • EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group (Pink Sheet)
  • England's NHS to offer Lilly's weight-loss drug to some patients (Reuters)
  • Gene Therapy Hemgenix Gains Ground In Europe With Spanish Reimbursement Deal (Pink Sheet)
  • UK Expedites Cost Negotiations For Companies Conducting ATMP & Early Phase Trials (Pink Sheet)
  • Anvisa To Access US FDA-Reviewed Data For More Robust Evaluations In Brazil (Pink Sheet)
  • EMA To Test New Ways Of Managing Conflicts Of Interest (Pink Sheet)
  • Rwanda to start vaccine trials for Marburg disease in a few weeks (Reuters)
  • Gilead to donate remdesivir for emergency use against Marburg disease in Rwanda (Reuters)
Pharma & Biotech
  • The latest obesity drug updates happening right now (STAT)
  • Ron Renaud, biotech’s serial CEO, is ready for a new assignment — and maybe another deal? (STAT)
  • Enara Bio’s $32.5M Series B to support lead dark antigen program for GI cancers (Endpoints)
  • Opdivo gets FDA approval for use around lung cancer surgery following Keytruda and Imfinzi (Endpoints)
  • Pfizer lays off staff in Ireland; Baxter closes NC facility due to hurricane damage (Endpoints)
  • Resolution raises $85M to test macrophage therapies in end-stage liver disease (Endpoints)
  • Septerna files for Nasdaq listing as biotech IPOs come to life (Endpoints)
Medtech
  • ResMed CEO on how wearables, GLP-1s will impact sleep apnea device sales (STAT)
  • Brain-computer interfaces are rapidly evolving. Here are six scientists shaping the field (STAT)
  • US FDA And AI: Who Is In Charge? (Pink Sheet)
  • BD agrees to settle most of its hernia mesh litigation (MedTech Dive)
  • Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices (FDA Law Blog)
Government, Regulatory & Legal
  • Becton Dickinson agrees to settle about 38,000 hernia mesh suits (Reuters)
  • Hospital at Home: Medicare report shows how the experiment is going (STAT)
  • US CDC warns of overdose risk from fake prescription medicines online (Reuters)
  • To aid addiction treatment, lawmakers tell DEA to back off buprenorphine enforcement (STAT)
  • Patient/CMS Roundtables For Medicare-Negotiated Drugs Will Be Interactive, But Not Public Next Time (Pink Sheet)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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