Recon: FDA panel weighs MDMA drug for PTSD; Annexon says GBS drug succeeds in Phase 3 trial
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Medicare Advantage plan’s quality ratings were incorrectly calculated by government, judge rules (STAT)
- Tracking the FDA advisory panel on MDMA therapy for PTSD (STAT)
- US FDA panel reviews psychedelic drug MDMA for the first time (Reuters)
- What the first four participants for FDA's Operation Warp Speed for rare diseases are tackling (Endpoints)
- Weight-loss drug developers line up to tap market worth $150 billion (Reuters)
- J&J must pay $260 million in latest talc trial, Oregon jury says (Reuters)
- Lawsuits pile up over state laws on discounts for hospitals' contract pharmacies (Reuters)
- Amended International Health Regulations Give Fresh Momentum To Pandemic Treaty Talks (Pink Sheet)
- Novo Holdings’ head of Asia on investing in ‘China for China,’ and staying out of biotech (for now) (Endpoints)
- EMA Stresses Importance Of Scientific Advice After Requests Drop 17% In 2023 (Pink Sheet)
- Swiss Pilot Allows Applicants To Discuss Preliminary Drug Approval Decisions (Pink Sheet)
- EU CHMP Opinions And MAA Updates (Pink Sheet)
- Biohaven’s autoimmune drug disappoints, and other biotech news updates from the week (STAT)
- Novartis is flashing warning signs about the fate of its newly acquired myelofibrosis drug (STAT)
- Viking expands on Phase 2b data for NASH drug, touting histological endpoints (Endpoints)
- BridgeBio spotlights 12 and 18-month data for potential achondroplasia drug in children (Endpoints)
- Vilya raises $21M in Series A extension; Shionogi to build research center in San Diego (Endpoints)
- Bristol Myers' Opdivo-Yervoy beats Lenvima and Nexavar in Phase 3 early liver cancer trial (Endpoints)
- Annexon proclaims Phase 3 win for complement inhibitor in Guillain-Barré Syndrome (Endpoints) (Reuters)
- Exclusive: Inspired by Spinraza, startup raises $25M for cancer drug targets created by alternative RNA splicing (Endpoints)
- COVID Vaccines: US FDA Seeks Panel Vote On New Formulation Targeting JN.1 Variant (Pink Sheet)
- Immuno-Oncology Add-On Trials: More May Not Be Better, US FDA Cautions (Pink Sheet)
- How a device maker inundated pain patients with unwanted batteries and surprise bills (STAT)
- Illumina board agrees to spin off Grail, as divestment plans proceed (STAT)
- Stryker inks Artelon buyout to join Zimmer in soft tissue space (MedTech Dive)
- Illumina names Everett Cunningham as chief commercial officer (MedTech Dive)
- Operation Warp Speed but for rare disease (STAT)
- Which hospital systems will join Kaiser’s Risant next? (STAT)
- Outdated Medicare rules prevent some dementia patients from getting the medications they need (STAT)
- Fauci denies suppressing COVID lab leak theory before US House panel (Reuters)
- The OIG Don’t Like That: Rockin’ The Casbah, Rockin’ the Casbah (FDA Law Blog)
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