Recon: FDA approves GSK’s Jemperli for endometrial cancer; Pfizer eyes cost cutting amid falling demand for COVID products

• GSK’s Jemperli Beats Merck’s Keytruda for Frontline Endometrial Cancer Approval (BioSpace) (Fierce) (Bloomberg) (Endpoints)
• All Carrots, No Sticks: House Republican Drug Shortage Plan Ups Reimbursement But Lacks Supply, Quality Commitments (Pink Sheet)
• Sage hopes for a blockbuster in fast-acting antidepressant now before FDA (STAT)
• Generic Hetlioz Does Not Require Braille Labeling, FDA Tells Vanda (Generics Bulletin)
• Siga snares $138M US government contract to supply small pox drug (Fierce)
• Vivek Ramaswamy wants to ‘gut’ the FDA. His claims don’t hold up to scrutiny (STAT)
• NIH begins long-delayed clinical trials for long Covid, announces new research office (STAT)
• As wildfires burn, scientists race to understand the health dangers of prolonged exposure (STAT)
• Medicare Prescription Drug Premiums Projected to Drop in 2024 (Bloomberg)
• Insight: Promising new Alzheimer's drugs may benefit whites more than Blacks (Reuters)

• India orders drugmaker linked to Cameroon cough syrup deaths to stop manufacturing (Reuters)
• Japan's Daiichi Sankyo gets approval for COVID vaccine, first for country (Reuters)
• EU, PAHO Ink €3.8m Deal To Boost Access To Health Technologies in Latin America & Caribbean (Pink Sheet)
• UK Explains New Product Labeling Rules From January 2025 (Pink Sheet)
• Consultation Deadline Approaches For Singapore's Draft API Regulation (Pink Sheet)

• Pfizer Misses on Q2 Revenue as COVID-19 Sales Tank, Narrows 2023 Forecast (BioSpace) (Endpoints) (Reuters) (MedWatch)
• Pfizer takes scalpel to early-phase pipeline, slicing off RSV, eczema, sickle cell and cancer programs (Fierce)
• Revolution to Buy EQRx in All-Stock Deal, Add $1B in Cash to Balance Sheet (BioSpace) (STAT)
• Biogen Aims to Replace $1.5 Billion M&A Bridge With Term Loans (Bloomberg)
• BioNTech completes acquisition and enters AI market (MedWatch)
• Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar (BioSpace)
• Updated: Merck Q2 earnings propelled by Keytruda, Gardasil sales, but expects 'slower' growth for HPV vaccine (Endpoints) (Reuters)
• TG Therapeutics signs $645M deal to kick-start international launch of MS antibody (Endpoints)
• ProQR draws line under its eye disease era, offloading 2 assets to Thea for $14M upfront (Fierce)
• Nymox airs dirty laundry about ex-CFO, ‘very worst’ partnership offer biotech has seen in 10-plus years (Fierce)

• FDA links 4 deaths to recalled Abiomed Impella pumps after TAVR collisions (Fierce)
• Baxter infusion pumps face another Class I recall, this time for possible false alarms (Fierce)
• Imeka’s brain mapping AI scores FDA clearance (Fierce)
• Jumping On The EU-US Adequacy Decision? Expert Says Wait And See (MedTech Insight)
• FDA To Expand TAP Pilot By Adding 5 Neurological Devices To The Program (MedTech Insight) (Bloomberg)
• Integra warns impact of plant closure will continue into 2024, with delays possible (MedTech Dive)
• Medical device maker Zimmer Biomet lifts profit forecast as surgeries rebound (Reuters)
• Verily hires former Apple Health leader Andrew Trister as chief scientific officer (STAT)

• US government OK with combining suits from Bristol Myers, J&J in IRA fight (Endpoints)
• Bristol Myers, AstraZeneca strike $510M settlement on PD-L1, CTLA-4 patent lawsuits (Endpoints) (Fierce)
• Astellas Sues Over New Myrbetriq Patent to Recapture Exclusivity (Bloomberg)