Recon: AstraZeneca priorities US market for RSV drug; Japan to ease rules on testing new drugs overseas

• AstraZeneca prioritizes US for RSV drug amid surge in cases (Reuters)
• In-Person Inspections Remain US FDA’s Preference Despite ‘Virtual’ Options (Pink Sheet)
• FDA Action Alert: Pacira, CorMedix, Aldeyra and More (BioSpace)
• FDA rules Otsuka marketing claim overstates Rexulti efficacy, threatening cornerstone of huge TV push (Fierce)
• Eli Lilly’s chief scientist on new obesity drug data, gene editing, and a potential new heart drug (STAT)
• BGOV Bill Summary: H.R. 5894, FY24 Labor-HHS-Education Funds (Bloomberg)

• Japan to scrap rule requiring testing of new drugs on Japanese (Nikkei Asia)
• Orphan Drugs Dominate Latest EU Filings (Pink Sheet)
• EU regulator backs GSK's bone marrow cancer therapy (Reuters)
• European Trade Groups Offer Unified Perspective On Pending Data Act (MedTech Insight)
• The U.K. just cleared a drug to prevent breast cancer. U.S. women may not know it’s already an option (STAT)
• WHO Still Backs Paxlovid In COVID-19 But Advises Against New Antiviral Deuremidevir (Pink Sheet)
• JCVI advice on the use of meningococcal B vaccination for the prevention of gonorrhoea (UK Joint Committee on Vaccination and Immunization)
• Second World Local Production Forum Launches New Collaborations; Civil Society Protests IP Barriers (Health Policy Watch)

• Wegovy cuts risk of heart attacks in milestone cardiovascular trial (STAT)
• Novo Nordisk wants to be a cardiovascular company, too, with sights set on inflammation (STAT)
• These are the need-to-know biotech stories from this weekend (STAT)
• Lilly Notches Second Cholesterol Win with RNA Silencer (BioSpace)
• Bayer withdraws follicular lymphoma drug after further trial fails (Reuters)
• In first test for base editing, Verve’s one-time treatment lowers cholesterol levels in patients (STAT)
• Aclaris shares plummet on terminating development of rheumatoid arthritis drug (Reuters)
• Ajinomoto to buy gene therapy CDMO Forge Biologics in $620M all-cash deal (Endpoints)
• Teva draws $100M from Royalty funding to bankroll long-acting schizophrenia drug (Fierce)
• Legend signs $100M deal with Novartis for next CAR-T bets, following up on Janssen success (Endpoints)
• Neurodegenerative disease-focused VectorY nabs $138M to bring ALS vectorized antibody to clinic (Endpoints)
• UCB, Eli Lilly-backed ViaNautis raises $25M in Series A to develop genetic nanomedicines (Endpoints)
• Alnylam’s longer-term RNAi treatment lowers blood pressure in mid-stage study (Endpoints)

• Stakeholders: Get Ready To Submit TAP Program Feedback In FY 2025 (MedTech Insight)
• European Trade Groups Offer Unified Perspective On Pending Data Act
• (MedTech Insight)
• Acon receives first FDA clearance for over-the-counter COVID-19 antigen test (MedTech Dive)
• What Amazon Prime’s new One Medical offering reveals about the future of health care (STAT)
• Patients loved Carbon Health’s diabetes program. That couldn’t save it (STAT)
• NYU radiologists tackle the challenge of making MRI machines less expensive (STAT)
• Acutus laying off 65% of employees to focus solely on Medtronic heart device deal (MedTech Dive)
• J&J orthopedics subsidiary undergoes layoffs at Colorado facility (MedTech Dive)
• Illumina explores options for Grail, hires advisers (MedTech Dive)
• News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope (MedTech Insight)

• Michigan bill that would pare back pharma liability shield law moves closer to enactment (STAT)
• Supreme Court Rejects Challenge to New Jersey Vaccine Mandate (Bloomberg)
• Health Policy Groups File Amicus Briefs Supporting IRA in Ongong AstraZeneca Lawsuit (FDAnews)
• It’s About Time: FDA’s Proposed Rule to Amend Prior Notice Regulations (FDA Law Blog)