Recon: FDA rejects Vanda’s stomach condition drug; EU authorizes Bavarian mpox vaccine for adolescents

• US FDA declines to approve Vanda's stomach condition drug (Reuters)        
• Lawmakers urge U.S. Patent Office and drugmakers to correct patent mistakes (STAT)
• FDA awards Novartis expanded approval for breast cancer therapy (STAT)
• Corbus sees Novo’s controversial obesity approach as a ticket to a blockbuster (STAT)
• 23andMe independent directors quit board over unsatisfactory buyout plan from CEO (Reuters)
• Exclusive: Flagship-backed Valo Health loses interim CEO ahead of key Phase 2 readout (Endpoints)
• FDA rejects Vanda’s treatment for digestion condition, company rebukes agency's actions (Endpoints)
• Integrating Trials Into Clinical Practice: US FDA Guidance Outlines Limited Use Cases (Pink Sheet)

• Bavarian says mpox vaccine approved by EU regulator for adolescents (Reuters)
• How The UK, EU, Canada, Australia And Japan Are Tackling Diversity In Clinical Trials (Pink Sheet)
• Ipsen On Working With The UK’s Health Authorities To Make Industry’s Voice Heard (Pink Sheet)
• EMA Tackles Hurdles To Using Single-Arm Trial Data For Pivotal Evidence In Filings (Pink Sheet)

• Genentech, a biotech with a storied past, confronts new turbulence in the present (STAT)
• A new cell therapy company takes its vision from four founders, and its skin from George Church (STAT)
• Obesity drug developer BioAge seeks up to $587 mln valuation in US IPO (Reuters)
• FDA inspectors discover trucks carrying torn-up records leaving Indian generics factory (Endpoints)
• Edgewise’s stock surges as heart drug passes early safety test (Endpoints)
• Ascendis aims to raise $300M; Basilea inks up to $268M deal with BARDA (Endpoints)
• Stem cell startup spun out of George Church’s lab raises $75M (Endpoints)
• BioCentriq names ex-Resilient exec as new CEO; Sanofi, AstraZeneca boost Beyfortus production (Endpoints)
• Fertility benefits giant Progyny loses client that accounted for 13% of its revenue (Endpoints)
• 4DMT's gene therapy reduced need for standard-of-care injections to treat age-associated vision loss (Endpoints)
• Sheryl Sandberg-backed Cercle raises $6M seed round with future plans to sell its services to pharma (Endpoints)

• Most cardiovascular devices with serious safety recalls aren’t tested in patients (STAT)
• Masimo proxy fight nears end as shareholder vote looms (MedTech Dive)

• Axonics defeats Medtronic lawsuit in spine-stimulation patent trial (Reuters) (MedTech Dive)
• Long-overlooked scientist shares Lasker Award with other GLP-1 researchers (STAT)
• Medicaid must prepare to cover twice-yearly HIV prevention injection (STAT)
• Compounded semaglutide is an ill-defined public health crisis (STAT)
• Q&A: Former NIH director Francis Collins on a Trump administration, science, and God (STAT)
• A Rare Good Day For PBMs On Capitol Hill (Pink Sheet)
• The National Products Association Challenges FDA’s Interpretation of the Dietary Supplement Exclusionary Clause (FDA Law Blog)