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May 16, 2024
by Jason Scott

Recon: Lilly’s weekly insulin found comparable to daily products; Biogen, Ionis end ALS drug program after early-stage miss

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

In Focus: US
  • Lilly’s weekly insulin works as well as daily products, new studies show (STAT)
  • Treating chronic pain requires much more than medications (STAT)
  • US unveils proposal to ease restrictions on marijuana (Reuters)
  • US FDA approves Amgen drug for small cell lung cancer (Reuters)
  • As childhood asthma worsens, insurers restrict access to an essential medication (STAT)
  • Biogen CEO Viehbacher undaunted by Lilly's impending Alzheimer's therapy, saying it will ‘expand’ market (Endpoints)
  • J&J makes small I&I acquisition to enter competitive IL-13, TSLP arena (Endpoints)
  • House panel advances bills targeting rare disease, priority review vouchers (Endpoints)
  • US Appeals Court Backs Dismissal Of Bystolic ‘Pay-For-Delay’ Case (Pink Sheet)
In Focus: International
  • WuXi Biologics pauses Massachusetts build; Novo Holdings nabs majority stake in pharma tools firm (Endpoints)
  • Novo Nordisk is optimistic that Kalundborg fire won't delay expansion (Reuters)
  • GSK, UK government budget £130M to fight global antimicrobial resistance (Endpoints)
  • As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs (Pink Sheet)
  • Drug Shortages: Pharma Decries 'Yet Another Tax' For Companies In Belgium (Pink Sheet)
  • EU Coordination Key To Speeding Up Combined Studies Of Drugs & IVDs/Devices (Pink Sheet)
Pharma & Biotech
  • PDS Biotech’s survival benefit is absurdly overstated (STAT)
  • Biogen and Ionis abandon ALS drug after disappointing early-stage trial (Endpoints)
  • Biogen, Ionis drop ALS treatment after study failure (STAT)
  • AstraZeneca's successor to Covid blockbuster Evusheld succeeds in Phase 3 trial (Endpoints)
  • Blackstone wants in on red-hot immunology market (STAT)
  • Obesity drug from Roche succeeds in early test, sending company shares up (STAT)
  • Galapagos, in makeover mode, strikes deal to make CAR-T therapies at blood centers across U.S. (STAT)
  • Novo to test Wegovy and other obesity drugs against alcohol-related liver disease (STAT)
  • Element Biosciences, an Illumina rival, on its genomics ambitions — and why it hasn’t gone public (STAT)
  • Roche teases 'encouraging' Phase 1 data for weight loss drug from $2.7B Carmot buyout (Endpoints)
  • Pfizer, Arvinas’ breast cancer drug combo keeps momentum after Phase 1b update (Endpoints)
  • Monte Rosa’s $100M offering; Alexion to hand back preclinical program to Zealand Pharma (Endpoints)
  • Bolt Biotherapeutics revamps as it drops lead cancer asset, changes CEO and trims headcount (Endpoints)
  • BeiGene looks at new partnerships, with a full cancer pipeline and growing footprint (Endpoints)
Medtech
  • Cue Health’s Covid-19 tests could give false results, FDA warns (STAT)
  • Stereotaxis inks APT buyout to gain catheters for surgical robots (MedTech Dive)
  • Dexcom details plans for over-the-counter CGM as insulin pump firms seek Type 2 coverage (MedTech Dive)
  • Getinge to limit US sales of heart devices after FDA safety warning (MedTech Dive)
  • GE Healthcare warns of cybersecurity risks in ultrasound devices, software (MedTech Dive)
Government, Regulatory & Legal
  • My rendezvous with the raw milk black market: quick, easy, and unchecked by the FDA (STAT)
  • CVS is willing to dump 10% of its Medicare Advantage members next year (STAT)
  • Boston Scientific recalls more than 1M angiographic catheters (MedTech Dive)
  • Abbott recalls Heartmate pump after 70 injuries, 2 deaths reported (MedTech Dive
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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