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April 23, 2024
by Jason Scott

Recon: FDA approves ImmunityBio bladder cancer treatment; Lawsuit alleges Novartis promoted asthma drug for preterm labor despite brain risk

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

In Focus: US
  • In a scientific first, researchers use CRISPR base editing to treat liver disease in fetal monkeys (STAT)
  • Trump surrogates hint at how he could reshape U.S. health care policy (STAT)
  • CDS Final Guidance Draws More Criticism, This Time From Congress (MedTech Insight)
  • ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages (Pink Sheet)
  • Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling (FDA Law Blog)
  • US FDA approves ImmunityBio's bladder cancer therapy (Reuters)
  • Alzheimer's drug adoption in US slowed by doctors' skepticism (Reuters)
In Focus: International
  • Second EU MDR Notified Body Designated In France (MedTech Insight)
  • WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency (Pink Sheet)
  • Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages (Pink Sheet)
  • Pfizer vs Moderna battle over COVID vaccine patents begins in UK (Reuters)
  • Novartis 'actively' reviewing relationships with Chinese contractors amid US biosecurity crackdown: CFO (Reuters)
  • Novartis raises guidance after beating Q1 expectations (Reuters)
Pharma & Biotech
  • Looking for signs of growth in Biogen’s earnings (STAT)
  • Pascal Soriot’s been pushing for US-sized CEO pay for more than a decade. Now he’s finally getting it (Endpoints)
  • Exclusive: In $1B+ bet on AI, biopharma heavyweights back new startup to upend drug R&D (Endpoints)
  • MarketingRx roundup: Cannes ad festival speakers to include Pfizer, Novo Nordisk; AZ adds TV commercial to NHL collab (Endpoints)
  • Novartis’ simplified strategy takes shape as the company seeks former Bristol Myers CEO as chair (Endpoints)
  • Novartis accused of promoting asthma drug for preterm labor despite brain risk (Reuters)
  • Brise raises $20M; Taro shareholder criticizes Sun Pharma deal (Endpoints)
  • Pharma companies tone down ESG mentions, but not ambitions (Endpoints)
  • Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director (Pink Sheet)
  • Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works (Pink Sheet)
  • Opinion: Bashing accelerated approval isn’t supported by the data (STAT)
  • Opinion: Use evidence to support early coverage of gene therapy after accelerated approval (STAT)
Medtech
  • Telehealth startups see an opportunity in long-ignored, complex chronic diseases (STAT)
  • Accreditation agencies take on telehealth with new virtual care standards (STAT)
  • Exclusive: Marc Tessier-Lavigne on leaving Stanford and joining biotech’s new AI mega-startup (Endpoints)
  • Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217 (MedTech Insight)
  • Quest Diagnostics raises 2024 profit and revenue forecast on strong demand (Reuters)
Government, Regulatory & Legal
  • How a scientific slip-up caused a pregnant woman to get an untested treatment for preterm birth (STAT)
  • Gerber, Perrigo sued over 'store-brand' infant formula prices (Reuters)
  • US Supreme Court faces fight over emergency abortions after toppling Roe (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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