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July 17, 2025
by Jason Scott

Recon: BMS, Pfizer to sell Eliquis direct to patients at a discount; Sarepta to layoff 500 staff as it adds boxed warning for DMD gene therapy

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

In Focus: US
  • Senators reveal how much Lilly, Pfizer paid telehealth companies (STAT)
  • FDA advisers vote against combination therapies of GSK's blood cancer drug (Reuters)
  • Bristol-Myers and Pfizer to Offer Blockbuster Blood Thinner at Discount (The Wall Street Journal)
  • Trump’s Medicare agency to speed up clawback of $7.8 billion in hospital drug payments (STAT)
  • RFK Jr.’s FDA may take cues on stem cells from red-state laws, clinic doctors (STAT)
  • House Bill Seeks to Help Veterans Access Alternatives to Opioids (Bloomberg)
  • Sarepta adds black box warning to its Duchenne treatment, cuts 500 workers (Endpoints) (Reuters)
  • Blood Pressure Rising: FDA Warning Letter Takes an Aggressive Approach on General Wellness Product (FDA Law Blog)
In Focus: International
  • Novo Nordisk Owner Buys Microsoft Quantum Computer With Denmark (Bloomberg)
  • UK HRA Sets Targets For Digital Overhaul, Trial Transparency & Trust (MedTech Insight)
  • Valneva Expects UK & France to Lift Ixchiq Age Restriction Following EMA Decision (MedTech Insight)
  • Trump’s U-Turn on Nvidia Spurs Talk of Grand Bargain With China (Bloomberg)
Pharma & Biotech
  • Could weight loss drugs like Ozempic help combat addiction? (STAT)
  • Boots Increases Dollar Loan Offering, Further Trims Bond Size (Bloomberg)
  • Novartis Drops as CFO Plans Retirement, Cosentyx Disappoints (Bloomberg) (Reuters)
  • Pfizer penicillin recall imperils syphilis treatment supply, particularly for pregnant women (Endpoints)
  • Massive proteomics study reveals new clues about Alzheimer’s and rekindles old ones (Endpoints)
  • BioNTech's strategy chief, who led deals to reshape company, will leave in September (Endpoints)
  • Three-person IVF technique spared children from inherited diseases, scientists say (Reuters)
Medtech
  • US FDA approves pre-filled version of GSK's shingles vaccine (Reuters)
  • Medicare plans to cover more than a thousand new procedures in outpatient settings, despite concerns about safety (STAT)
  • Thermo Fisher buys Sanofi factory; Amphastar Pharma quadruples HQ capacity (Endpoints)
  • Abbott Drops on Outlook Cut, Sees $200 Million Tariff Impact (Bloomberg) (Reuters)
  • Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility (MedTech Insight)
Food & Nutrition
  • FDA revoking ‘Standards of Identity’ for more than 50 foods (Food Safety News)
  • Trump says Coca-Cola to switch to cane sugar in U.S. — just like Mexican Coke (The Washington Post)
  • FMI Urges FDA to Revise Food Traceability Rule as Part of Agency’s Deregulation Efforts (Food Safety Magazine)
Government, Regulatory & Legal
  • FDA Authorizes Juul’s E-Cigarettes, Reversing Ban That Nearly Bankrupted Firm (WSJ) (Reuters)
  • Study finds no evidence aluminum salts in vaccines are tied to higher risk of asthma, other childhood diseases (STAT)
  • Kennedy dismisses two top HHS aides (STAT)
  • Medical research participants deserve to be paid well (STAT)
  • Stop Playing Whac-a-Mole With Forever Chemicals (Bloomberg)
  • Senate Bill Would Hasten Health Data From Insurers to Employers (Bloomberg)
  • FDA hits Daewoo Pharma with warning letter over potentially poisonous contaminants (Endpoints)
  • FDA drugs center sees sharp rise in staff departures since January (Endpoints)
  • Elevance cuts forecast as rising costs hit health insurers (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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