Recon: FDA panel weighs MDMA drug for PTSD; Annexon says GBS drug succeeds in Phase 3 trial

• 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)