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)
- 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)
- 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)
- 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)
- 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)
- 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)
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