Recon: Experts press FDA to set safety, access standards for psychedelic drugs; GSK to shut German vaccine factory due to low demand

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• Experts urge FDA to set clear safety and access standards for psychedelic drugs (Reuters)
• FDA should require credentials for psychedelic providers, experts say (Endpoints)
• Trust in measles vaccines falls in US, Reuters Ipsos poll finds (Reuters)
• Lilly says Foundayo has captured over 30% of new US patients on oral weight-loss drugs (Reuters)
• Scholar Rock says its first muscle-targeted SMA therapy will cost about $310,000 annually (Reuters)
• Testosterone scripts for women rise, along with denials and delays (Reuters)
• FDA takes applications for new program to shorten drug approval times (STAT) (Endpoints)
• Kennedy to deliver keynote for anti-vaccine group he once led (STAT)
• Montana’s giving the biotech industry sweeping authority to sell unapproved drugs (Politico)
• China Security Fears Could Delay PDUFA Reauthorization, US FDA Warns (Pink Sheet)

In Focus: International

• Novo CEO urges staff to embrace more customer-focused culture (Reuters)
• Novo Eyes EMA Nod For Denecimig After Securing Saudi Approval (Pink Sheet)
• Gilead, PAHO agree on HIV prevention drug access in Latin America, Caribbean (Reuters)
• Ovarian And Lung Cancer Therapies Await EMA Verdict After Wins In US, China (Pink Sheet)
• Wiping out measles impossible due to vaccine hesitancy in rich countries, says Gates (Reuters)
• UN sees some progress in Congo Ebola fight, but too early to call peak (Reuters)
• GSK to wind down German vaccine factory due to lack of demand (Endpoints)

Pharma & Biotech

• FDA looks into reassessing criteria around rare disease trials, endpoint selection (Endpoints)
• FDA approves first radioligand generic, setting up rivalry with Novartis (Endpoints)
• Legend Biotech taps Novartis veteran Zhang as CEO (Reuters)
• Lilly pledges up to $237M per program in CNS genetic med collab with Canadian biotech (Fierce)
• FDA clears first generic radioligand drug; Sionna turns to layoffs (BiopharmaDive)
• Sionna cuts nearly half of staff as it lines up second attempt at cystic fibrosis (Endpoints)
• Centric Compounding recalls three injectables over contamination (Endpoints)
• Axoltis says its Phase 2 study for an experimental ALS drug failed (Endpoints)
• BioMarin drops Voxzogo development for Noonan syndrome as treatment landscape shifts (Fierce)
• Contineum, J&J's drug fails in mid-stage depression trial (Endpoints)

Medtech

• Intuitive single-port robot earns CE mark for new indication (MedtechDive)
• FDA Cor MDx Clearance Puts Peerbridge’s Predictive Health Ambitions Within Reach (MedtechInsight)
• Medtronic Moves to Complete MiniMed Separation (MedtechInsight)
• Mayo Clinic teams with Thermo Fisher to form biomedical data group Precure (Fierce)
• Newly formed Jaguar acquires Afib device assets from J&J (Fierce)
• After rejection, FDA approves Telix’s Pixclara, the first FET-PET imaging drug for brain cancer (Fierce)

Government & Legal

• HHS official Klomp spars with Warren over drug pricing contracts (Endpoints)
• Abbott to pay $384 million over contaminated infant formula allegations, US Justice Dept says (Reuters) (STAT)
• OIG urges crackdown on equipment suppliers in Medicare Advantage (HealthcareDive)

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.