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July 9, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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