Recon: FDA approves Moderna's COVID shot for at risk children; Merck to buy Verona for $10B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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