Recon: FDA greenlights Seres’ oral microbiome drug; Bristol Myers names new CEO as generic competition rises

• FDA approves Seres microbiome drug, as field advances (STAT) (Endpoints) (Fierce)
• AstraZeneca’s Lynparza: US FDA Frowns Upon ‘All Comers’ Indication In First-Line Prostate Cancer (Pink Sheet) (Endpoints) (BioSpace)
• Eli Lilly’s Mounjaro succeeds in second weight-loss study, paving way for FDA review (STAT)
• FDA issues warning letter to another manufacturer over possible glycol contamination (Endpoints)
• Following CRL, Form 483 reveals more quality issues at Alvotech’s production facility in Iceland (Endpoints)
• HHS Gives Out $147 Million to Support Ending US HIV Epidemic (Bloomberg)
• Penicillin in Shortage in US as Syphilis, Strep Cases Rise (Bloomberg)
• Antibiotic Resistance: Federal Agencies Have Taken Steps to Combat the Threat, but Additional Actions Needed (GAO)
• After shutting down, Akron recalls its 70-plus products nationwide (Fierce)
• U.S. indictments trace fentanyl supply lines from China to Mexico (Washington Post)
• 4 dead, 31 infected after bacterial outbreak hits Seattle hospital (USA Today)
• Senate HELP Panel PBM Bill Requires Rebate Pass-Through, But Not To Plan Members (Pink Sheet)

• Pharma industry taking to the barricades after presented extensive EU pharma reform (MedWatch)
• EMA OKs Seven New Drugs Including First RSV Vaccine For Older Adults (Pink Sheet)
• EU Proposes ‘Last Resort’ Plan to Order Production of Key Drugs (Bloomberg)
• The US Should Follow the EU and Standardize Green Product Labels (Bloomberg)
• England’s Innovative Medicines Fund Needs De-Risking To Make It Work (Pink Sheet)
• AstraZeneca increases bets on China as COVID vaccine sales fade (Reuters)

• Drugmakers scout for deals, ramp up research spending (Reuters)
• Merck beats first-quarter expectations on Keytruda, Gardasil strength (Reuters)
• Bristol’s Boerner To Succeed CEO Caforio With Launch Execution In The Spotlight (Scrip) (Reuters) (BioSpace)
• Biopharma feels momentary relief as Supreme Court preserves abortion drug access—for now (Fierce)
• Foresight Diagnostics' approach for the earlier detection of cancer recurrence pulls in nearly $59M (Endpoints)
• Sangamo cuts 120 jobs, announces prioritized pipeline to extend cash runway another year (Endpoints)
• BMS To Take Over Novartis Plant In Effort To Boost Viral Vector Production For CAR-Ts (Scrip) (Endpoints)
• Sanofi Cleans House, Cuts Assets from Principia and Ablynx Buyouts (BioSpace) (Endpoints)
• Alnylam’s ‘upstream’ Alzheimer’s treatment shows early promise (STAT) (Endpoints)
• In pleasant surprise for Roche, Vabysmo blasts off as company’s biggest growth driver (Fierce)
• AstraZeneca dumps $855M, near-approval rare disease drug after talks with regulators (Fierce)
• GSK's new RSV campaign lands in advance of FDA decision set for next week (Endpoints)
• AbbVie's weak newer drug sales fan worries as Humira faces rivals (Reuters)
• Eli Lilly raises annual profit forecast on strength of diabetes drug (Reuters)
• Novartis ups the ante in AstraZeneca blood disorder showdown with fresh data (Fierce)
• After gathering enough Nektar, Lilly hands back rights to immunology med post-lupus fall (Fierce)

• Medcon 2023: FDA Hopes To Release Final QMSR By Year’s End (MedTech Insight)
• EU Regulatory Round-Up, April 2023: Global Regulatory Issues Dominate EU Thinking (MedTech Insight)
• Medtronic wraps up response to FDA warning letter over quality issues at diabetes HQ (Fierce)
• Baxter restructures with spin-off of kidney care business still planned for 2024 (MedTech Dive)
• Boston Scientific still surging upward, with 12% sales bump amid product launches, M&A moves (Fierce)
• 3M layoff tally climbs to 8,500 in companywide restructuring ahead of healthcare spinout (Fierce)

• Eli Lilly Verdict in Whistleblower’s Fraud Suit Mostly Upheld (Bloomberg)
• Vidal to Highlight Patent Trial Transparency Progress on Hill (Bloomberg)