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May 23, 2024
by Jason Scott

Recon: Pfizer looks to cut $1.5B in spending by 2027; Drugmakers prevail in first Zantac cancer trial

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • In light of H5N1 outbreak, US in talks with mRNA vaccine makers on bird flu (STAT)
  • Biotechs turn to gene silencing for obesity drugs that can last longer than Wegovy (STAT)
  • Merck KGaA avoids prosecution after cooperating with DOJ to uncover China export scheme (Endpoints)
  • Pfizer rolls out another cost-cutting program, sets $1.5 billion target by 2027 (Reuters) (Endpoints)
  • Zantac not a cause of woman’s cancer, jury says in first trial over drug (Reuters)
  • Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach (Pink Sheet)
  • US FDA staff flags risk of low blood sugar for Novo Nordisk's weekly insulin (Reuters)
  • Medtronic's weaker-than-expected outlook clouds quarterly results beat (Reuters)
  • In sleep apnea device litigation, who's getting the $1.1 billion settlement? (Reuters)
In Focus: International
  • EU reports no bird flu cases in humans or cows as virus spreads in US (Reuters)
  • EMA Answers More Questions For Manufacturers of Drug-Device Combos (Pink Sheet)
  • Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials (Pink Sheet)
  • Deadline Nears For Comments On WHO’s Proposed Requirements For MAbs Targeting RSV (Pink Sheet)
  • Novel Antimicrobials: Firms Urged To Draw Up Access & Stewardship Plans For Lower-Income Countries (Pink Sheet)
Pharma & Biotech
  • Cytokinetics CEO Robert Blum is on my Worst CEO shortlist again, and other thoughts (STAT)
  • Cytokinetics sells Royalty Pharma a share of its heart drug for up to $575 million, lowering hopes of a buyout (STAT)
  • ReNAgade is acquired by RNA rival a year after megaround-backed launch (Endpoints)
  • Bicycle’s $555M placement; Tango Therapeutics scraps cancer program (Endpoints)
  • Exclusive: SR One raises $200M+ for third fund, still with GSK support (Endpoints)
  • Chinese CDMO takes over Pfizer’s UK facility; Serum Institute ships malaria vaccine to Africa (Endpoints)
  • Atropos Health raises $33M to arm doctors and pharma companies with evidence (Endpoints)
  • Exclusive: Senior primary care startup Gather Health has raised $16M in a new round (Endpoints)
  • Startup launches with ‘RNA sensor’ technology from Stanford and MIT to better control mRNA therapies (Endpoints)
  • AstraZeneca taps more China-derived tech with $19M cancer deal for Nona antibodies (Endpoints)
Medtech
  • Hologic recalls more than 53,000 radiographic markers linked to 71 injuries (MedTech Dive) (Reuters)
  • Cue Health, Covid-19 testing company, is shutting down (STAT)
  • Medtronic touts demand for PFA, adding to hype for the new ablation tech (MedTech Dive)
  • Medicare adviser sets recommendations for diabetes device evidence (MedTech Dive)
Government, Regulatory & Legal
  • Wastewater testing specifically for bird flu virus will scale up nationally in coming weeks (STAT)
  • Fresh scrutiny of post-Covid spending reignites yearslong tension over emergency stockpiles (STAT)
  • Making the case for fair compensation in clinical trials (STAT)
  • UnitedHealth argues algorithm lawsuit should be dismissed because patients didn’t spend years appealing denials (STAT)
  • Tobacco industry aims to hook new generation on vapes, WHO says (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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