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)
- 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)
- 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)
- 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)
- 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)
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