Recon: FTC reports says PBMs seek profits to detriment of patients and pharmacies; Pfizer’s chief scientist to step down
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Lilly’s Kisunla Postmarketing Studies Include Maintenance Dosing, But No Safety Trial (STAT)
- Mikael Dolsten, Pfizer CSO who could take on Covid but not Wall Street, to step down (STAT)
- Drugmakers are losing crucial friends on Capitol Hill (STAT)
- FTC report finds PBMs profit at the expense of patients and independent pharmacies (STAT) (Reuters)
- Explainer: Why are US pharmacy benefit managers under fire? (Reuters)
- Biopharma’s 20 highest-paid CEOs of 2023, earning $20M+ pay packages (Endpoints)
- House speaker plans vote on Biosecure Act as part of China legislation push (Endpoints)
- US FDA’s Cavazzoni To Manufacturers: Pay Attention To Data Received From CROs (Pink Sheet)
- US FDA Makes Misinformation Correction Easier For Pharma (Pink Sheet)
- U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
- Nordic HTA Initiative Offers ‘Practice Ground’ For Worrisome EU-Level Joint Clinical Assessment (Pink Sheet)
- Swissmedic Cracks Down on Vague Drug Indications & Tightens Assessments of CCI Claims (Pink Sheet)
- Getting To Global Is A Hurdle For Cell And Gene Therapies (Pink Sheet)
- Sellers of fake Ozempic to face charges in Austrian court (Reuters)
- The maddening saga of how an Alzheimer’s ‘cabal’ thwarted progress toward a cure for decades (STAT)
- Lilly’s obesity drug looks more potent than Novo’s in observational study (STAT)
- A faster, simpler, cheaper cancer cell therapy is about to be tested in humans (STAT)
- UniQure trumpets mid-stage data for Huntington's disease gene therapy (Endpoints)
- Kymera's stock rises after derma investigation expands; Ligand buys Apeiron (Endpoints)
- A rare voice box transplant helped a cancer patient speak again, part of a pioneering study (STAT)
- Philips recall of imaging coils tied to 12 injuries (MedTech Dive)
- Masimo offered up to $950M for consumer business (MedTech Dive)
- Pulse drops 510(k) plan for PFA device after FDA requests clinical data (MedTech Dive)
- Baxter considers sale of kidney care unit to PE firm: WSJ (MedTech Dive)
- Quest to buy Lifelabs for $985M (MedTech Dive)
- Wall Street analysts bullish on genetic testing firm Tempus AI (Reuters)
- Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic (MedTech Insight)
- Clinicians: ‘Show Me The Impact And Outcomes Of AI Tools’ (MedTech Insight)
- The untold story of the Human Genome Project: How one man’s DNA became a pillar of genetics (STAT)
- Everyone deserves addiction treatment that works — including those in jail (STAT)
- US government appeals Gilead's trial win in Truvada, Descovy patent fight (Fierce Pharma)
- Johnson & Johnson pays $50M to resolve its ugly divorce with Emergent BioSolutions (Fierce Pharma)
- Abbott faces trial over claims that preterm infant formula caused dangerous disease (Reuters)
- Purdue creditors seek approval to sue Sackler family members (Reuters)
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