Recon: FDA approves Moderna's COVID shot for at risk children; Merck to buy Verona for $10B

• Moderna gets full US approval for COVID shot in at-risk children 6 months and older (Reuters)
• US FDA publishes 200 complete response letters from archive in transparency drive (Reuters) (STAT)
• J&J defeats generic drugmakers in US appeal over schizophrenia treatment (Reuters)
• Merck to buy lung-disease biotech Verona Pharma for $10 billion (STAT) (FT)
• US FDA approves gradual dosing for Lilly Alzheimer's drug (Reuters)
• FDA’s pediatric adcomm votes to continue surveillance of 21 drugs, three vaccines (Endpoints)
• Federal judge sides with FDA on its mifepristone safety program (Endpoints)
• Kennedy abruptly cancels preventive care committee meeting (STAT)
• HHS backtracks on pledge to disclose new vaccine advisers’ conflicts of interest (STAT)
• New Research Questions Severity of Withdrawal From Antidepressants (NYTimes)
• FDA won’t pay 2024 bonuses to workers who are getting laid off (STAT)
• Senate Approps approves Ag-FDA bill (Axios)

• EU Sets Out New Plan to Boost Health Crisis Readiness (EC 1, 2)
• EUDAMED Notice Anticipated By September As Commission Optimizes Operations (MedtechInsight)
• Pfizer, BioNTech ask UK court to overturn Moderna's COVID vaccine patent win (Reuters)
• Review of AI/ML applications in medicines lifecycle (2024) (EMA)
• Poor nations try to bridge AIDS funding gap but prevention efforts dwindle, UN says (Reuters)
•  India's Glenmark Pharma unit, AbbVie sign exclusive licensing pact (Reuters)
• Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden (MHRA)
• Hims & Hers to offer generic semaglutide in Canada as Novo Nordisk patent lapses (CNBC)

• In first half of 2025, novel drug approvals are in line with previous years (Endpoints)
• Who pays the most in biopharma? We analyzed median pay at 177 companies (Endpoints)
• Varda Space raises $187 million to accelerate development of drugs in space (Reuters)
• US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality (Pink Sheet)
• US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions (Pink Sheet)
• Child walks again after receiving experimental treatment for rare genetic condition (STAT)
• Elanco's dog flu vaccine gets USDA nod (Reuters)
• Jazz taps current COO Renée Galá to replace CEO and co-founder Bruce Cozadd (Endpoints)
• AbbVie inks $700M deal with IGI for multiple myeloma trispecific antibody (Endpoints)
• AstraZeneca hands over opioid addiction pill to Eolas; TandemAI, Perpetual Medicines merge (Endpoints)
• Soleno's first wave of rare disease drug sales beats expectations (Endpoints)
• Biotech’s Q2 numbers paint a picture of the good, the bad and the ugly (Endpoints)
• Ultragenyx, Mereo’s bone disease drug fails second interim analysis, stocks plummet (Endpoints)
• Renasant Bio, an underdog in the race to develop kidney disease therapies, raises $54.5 million  (STAT)
• Use of antibiotic to reduce STIs appears to be fueling some antibiotic resistance, research shows STAT)

• FDA clears over-the-counter, cuffless blood pressure monitor with the Hilo bracelet (Fierce)
• Mendaera scores FDA clearance for handheld robotic needle delivery system (Fierce
• Medtronic treats first patient in multi-organ denervation study for high blood pressure (Fierce)
• Abbott gains national CMS coverage for tricuspid valve repair (MedtechDive)
• Boston Scientific expands Farapulse’s reach in afib with new FDA approval (Fierce)
• Alcon to buy LumiThera’s light-based therapy for dry AMD (Fierce)

• FDA Shares Recall Communication Improvement Efforts, Encourages Transparency From Infant Formula and Baby Food Industry (Food Safety Magazine)

• Senate committee advances Susan Monarez to be Trump’s CDC director (STAT)
• US health department widens immigrant benefit restrictions (Reuters)
• US NIH to cap publisher fees for federally funded research by 2026 (Reuters)
• Purdue Case Could Transform Patent Obviousness Analyses (Law360)
• Fed. Circ. Cements Arthrex PTAB Wins Over Medical Device IP (Law360)
• Sandoz, Buyers Defend $275M Deal Amid State Objections (Law360)
• Federal Regs Order May Spell Harsher FDCA Enforcement (Law360)
• Prosecutors Question Doctors About UnitedHealth’s Medicare Billing Practices (WSJ)
• J&J prevails in schizophrenia drug patent spat against Teva (Endpoints)