Recon: FDA rejects Vanda’s stomach condition drug; EU authorizes Bavarian mpox vaccine for adolescents
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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