Recon: AbbVie’s Parkinson’s drug succeeds in Phase 3 study; Merck’s Keytruda combo misses survival endpoint in late-stage ovarian cancer study

• AbbVie drug succeeds in another Parkinson’s trial (STAT) (Reuters)
• Merck's Keytruda combo misses overall survival in Phase 3 trial in ovarian cancer (Endpoints)
• BIOSECURE Act, aimed at Chinese drug manufacturers, is dealt a major blow (STAT)
• Pfizer’s abrupt withdrawal of sickle cell drug Oxbryta called ‘tone deaf’ at ASH conference (STAT)
• Trump suggests he shares some of RFK Jr.’s concerns about childhood vaccines (STAT)
• FDA must disclose more COVID-19 vaccine records, US judge rules (Reuters)
• Confirmatory Trials: US FDA Toughens Stance On Need For Advance Planning, Due Diligence (Pink Sheet)

• Cause of outbreak in DRC still being investigated, health officials say (STAT)
• WHO sheds some light on factors possibly at play in DRC outbreak (STAT)
• Centralized Medtech Regulation: Which Way Should The EU Go? (MedTech Insight)
• EMA Encourages Swift Data Insertion As European Shortages Monitoring Platform Goes Live (Pink Sheet)
• EU Decision Time For Orphans Acoramidis, Garadacimab & Imetelstat, Plus 10 Other Products (Pink Sheet)
• EMA Homes In On How To Improve RWD Quality (Pink Sheet)

• This father built a gene therapy for his son. Now comes the harder part: saving others’ children, too (STAT)
• Biotech companies detail emerging efforts to ease ‘conditioning’ before genetic treatments (STAT)
• Young biotech venture firm raises $500 million for its second fund (STAT)
• Revance agrees to lower take-private offer by Crown Labs (Reuters)
• Relmada discontinues late-stage trials for depression drug, explores sale (Reuters)
• BioAge scraps mid-stage trial of experimental obesity drug, shares fall (Reuters)
• Dimension nabs $500M second fund for 'still contrary' intersection of bio and machine learning (Endpoints)
• ADC scientist who paved the way for Daiichi’s Enhertu dies (Endpoints)
• AbbVie, Genmab tout Epkinly combos in earlier lines of non-Hodgkin lymphoma (Endpoints)
• FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1) (FDA Law Blog)
• Some research shows patients don’t stick with GLP-1s for long. Amazon Pharmacy and Ro say they're changing that (Endpoints)
• Enanta's mid-stage win in pediatric RSV; Carisma to lay off 34% of staff (Endpoints)
• Beam shares results from seven patients who received gene-edited sickle cell therapy (Endpoints)

• Mental health apps need a complete redesign (STAT)
• AI-enabled apps top ECRI’s list of health tech hazards in 2025 (MedTech Dive)
• Smith & Nephew laying off about 150 employees in Tennessee (MedTech Dive)
• Cleerly raises $106M to fund AI-driven heart disease tool (MedTech Dive)
• Embecta to cut 125 jobs after ending insulin patch pump (MedTech Dive)

• Killing of UnitedHealthcare CEO brings resentment of the health care system to the fore (STAT)
• Exclusive: US issues order mandating bird flu testing of milk supply (Reuters)
• ICER finds Vertex's non-opioid pain treatment could bring cost savings at a lower price (Endpoints)
• Former Senate Republican Health Leader Not Concerned About Anti-Pharma Stance of Trump’s HHS Appointees (Pink Sheet)
• House Coronavirus Subcommittee Report May Turn Up Heat On FDA (Pink Sheet)