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December 12, 2023
by Jason Scott

Recon: Pfizer to conclude $43B Seagen purchase after giving away cancer drug rights; J&J touts phase 3 results for multiple myeloma therapy

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

In Focus: US
  • New sickle cell disease CRISPR treatments can’t make up for the shortage of adult hematologists (STAT)
  • A Final LDT Rule in April!? Will FDA be Prepared? (FDA Law Blog)
  • Puberty Blocker Petition Raises Questions About When FDA Should Weigh In On Off-Label Drug Use (Pink Sheet)
  • Rx Drug Ads Should Not Characterize Probability Of Risk As Insignificant, FDA Emphasizes (Pink Sheet)
  • US diabetes patients face delays as insurers tighten Ozempic coverage (Reuters)
  • Weight loss from Lilly's Zepbound reversed after stopping treatment, study shows (Reuters)
  • White House wants to set minimum cyber standards for hospitals, healthcare (MedTech Dive)
In Focus: International
  • EU publishes its first list of more than 300 critical medicines, vaccines (Reuters)
  • EU Explains Steps Sponsors Must Take When Using Companion Diagnostics In Drug Development (Pink Sheet)
  • EMA Verdict Due On Vertex/CRISPR’s Gene Editing Therapy & Reata’s Omaveloxolone (Pink Sheet)
  • Gavi Provides Funding For ‘Pandemic-Ready’ Vaccine Partners (Pink Sheet)
Pharma & Biotech
  • Pfizer gets OK for $43-billion Seagen deal after donating cancer drug rights (Reuters)
  • AstraZeneca Buys into RSV Vaccine Market with Potential $1.1B Icosavax Purchas (BioSpace) (Reuters)
  • Late-stage trial supports broader use of Darzalex, blockbuster J&J multiple myeloma drug (STAT)
  • With big ambition — and a family name to match — Reed Jobs charts his own course in biotech (STAT)
  • Tome Biosciences goes public today in another biotech megaround (STAT)
  • A targeted therapy shows it can offer a ‘last, great chance’ for some acute leukemia patients (STAT)
  • Moderna's chief commercial officer out as company reorganizes (Endpoints)
  • Resilience plans to expand Ohio facility with 440 new jobs over three years (Endpoints)
  • Almirall partners with etherna; Daiichi's RNA deal with Depixus; SQZ founder's startup emerges from stealth (Endpoints)
  • After groundbreaking year for RSV approvals, GSK looks to model pediatric success for adult vaccines (Endpoints)
  • Klick Health offers $1M prize pool for agency employees with innovative AI solutions (Endpoints)
Medtech
  • Why heart device makers are investing in left atrial appendage closure (MedTech Dive)
  • Activist investor takes stake in Nevro amid struggles to grow neuromodulation sales (MedTech Dive)
  • Bayer Extends Personalized Health Offering With At-Home Biological Age Test (MedTech Dive)
  • Medtronic expands AI endoscopy partnership with Cosmo (MedTech Dive)
  • Hologic promotes Essex Mitchell to COO (MedTech Dive)
  • Class I Recall For Getinge CARDIOHELP System (MedTech Insight)
  • News We’re Watching: Activist Investor Causes Kerfuffle At Nevro, Lifespin Launches Antibiotic Dx, And More (MedTech Insight)
Government, Regulatory & Legal
  • Sanofi ends deal for a rare disease drug after FTC voices monopoly concerns (STAT)
  • J&J, Lupin Agree Erleada Copy Won’t Infringe Cancer Drug Patent (Bloomberg)
  • Teva Petitions Federal Judge in Colorado to Reject Motion to dismiss Epi-Pen Lawsuit  (FDAnews)
  • Eagle Pharmaceuticals Allegedly Misled on Cancer Drug Revenue (Bloomberg)
  • US consumer group seeks stronger warnings on Botox, similar treatments (Reuters)
  • US panel recommends children with obesity start counseling from age 6 (Reuters)
  • Sickle Cell Gene Therapy Uptake May Lag, But Still Shock State Medicaid Budgets (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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