Recon: US FDA panels return to normal and schedule filling up; Judge rules that J&J must pay Auris investors over $1 billion for violating merger

• They’re Back! US FDA Panels Return To Normal And The Schedule Fills Up Fast (Pink Sheet)
• Merck executive plays down impact of new lung cancer drug data on Keytruda (STAT)
• With a win in lung cancer, biotech’s wealthiest outsider surfs to new heights (STAT)
• Terns’ oral GLP-1 passes Phase 1 test with promising weight loss after one month (Endpoints)
• Merck, Daiichi Sankyo detail Phase 2 ADC results in small cell lung cancer, bispecific combo strategy (Endpoints)
• Immunovant shares mid-stage Graves’ disease data; FDA lifts Rezolute’s hold (Endpoints)

• Landmark Guidance For Curbing Antibiotic Pollution Considers Impact On Pricing & Supply (Pink Sheet)
• EMA Probe Prompts New Safety Measures For Decades-Old Drug Metamizole (Pink Sheet)
• Clinical Trials In China: As US Lawmakers Consider Crackdown, Here Are The Implications (Pink Sheet)
• DRC Gets First Mpox Vaccine Shipment & Issues EUA Ahead Of WHO Listing (Pink Sheet)
• EU Regulators Should Use AI Only When ‘Safe And Responsible,’ Says EMA (Pink Sheet)

• RayzeBio, Dice alums raise $370 million for new autoimmune startup (STAT)
• Relay discloses encouraging results for experimental breast cancer treatment (STAT)
• Breakthrough therapies have given Duchenne muscular dystrophy families like mine hope — and new fears (STAT)
• #ESMO24 roundup: New data on Amgen’s PRMT5 inhibitor seem lackluster, and Jazz’s HER2 antibody (Endpoints)
• AstraZeneca's monoclonal antibody misses primary endpoint in mid-stage trial in COPD (Endpoints)
• Bicycle Therapeutics makes an early case for its Padcev competitor: #ESMO24 (Endpoints)
• Lilly again hires from within for CFO post, elevating 23-year company veteran (Endpoints)

• Court orders J&J to pay $1B following buyout of surgical robotics company (Endpoints)
• Lab group urges lawmakers to rescind FDA final rule on LDTs (MedTech Dive)
• Many FDA-authorized AI devices lack validation data (MedTech Dive)
• Illumina court ruling limits EU regulators’ merger review power (MedTech Dive)
• Abbott debuts Lingo over-the-counter CGM in the US (MedTech Dive)
• BD Sees Bright Future For Edwards’ Critical Care, Now BD Advanced Patient Monitoring (MedTech Insight)

• Inside the bruising battle to purge race from a kidney disease calculator (STAT)
• How Pfizer ended up passing on my GLP-1 work back in the early ’90s (STAT)
• She was told she might have cancer: How medicine pathologizes Black patients’ normal test results (STAT)
• Highmark reboots coverage of digital treatments, raising hope among DTx companies (STAT)
• Glenmark Shells Out Another $25m To Resolve Civil Price-Fixing Charges (Pink Sheet)