Recon: AstraZeneca’s Voydeya for rare blood disorder wins FDA approval; FDA delays review of Biogen’s and Eisai’s injectable Leqembi

• GLP-1 generics would be dramatically cheaper than U.S. price of Ozempic, study shows, but still profitable (STAT)
• What’s Congress going to do with WuXi? (STAT)
• Congressional Hearing on LDTs: Split on FDA Regulation but Support for VALID (FDA Law Blog)
• FDA gives the green light to AstraZeneca's rare blood disorder drug Voydeya, following approval in Japan (Endpoints)
• Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data (Fierce Pharma)
• 'Unprecedented' demand for Eli Lilly's Zepbound sparks US supply constraints (Fierce Pharma)
• US CDC’s Adult RSV Vaccine Recommendations In Flux With Impending FDA Approvals (Pink Sheet)

• Critics say U.K. decision on ALS drug could have ‘chilling effect’ on access to new genetic medicines (STAT)
• Old tweet, new problem: PMCPA chides Pfizer over UK staffer's 2020 Twitter misstep (Fierce Pharma)
• Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs (Pink Sheet)
• WHO Launches Twin-Track Procedure To Speed Access To Health Products (Pink Sheet)
• England’s NICE Says No To Santhera’s DMD Drug Agamree Due To ‘Unreliable Modeling’ (Pink Sheet)
• EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions (Pink Sheet)
• Japanese authorities inspect second Kobayashi Pharma factory after deaths (Reuters)

• Aardvark Therapeutics gearing up for $200 million IPO (STAT)
• Bristol Myers' Zeposia expansion plans hit by Phase 3 setback in Crohn's disease (Endpoints)
• Contineum says it will seek $136M in IPO to back its mid-stage neuro drug (Endpoints)
• Carlyle’s Abingworth will help fund Teva’s Phase 3 asthma rescue inhaler (Endpoints)
• Precigen adds to disease awareness calendar with day dedicated to recurrent respiratory papillomatosis (Fierce Pharma)
• Pfizer shifts creative business to Publicis in latest marketing move (Fierce Pharma)

• Q&A: Insitro CEO Daphne Koller on ‘potentially destructive’ AI hype, Nvidia's chips, and biotech's data problem (Endpoints)
• Exact Sciences, Mayo Clinic share early data on esophageal cancer test (MedTech Dive)
• J&J’s Aldo Denti on digital technology in orthopedics (MedTech Dive)
• Labcorp inks $237.5M buyout of Opko’s reproductive, women’s health testing assets (MedTech Dive)
• EU Must Crack Down Harder On Fake Medical Devices, Says Innovator (MedTech Insight)
• Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices (MedTech Insight)

• People in Republican-voting states more likely to report Covid-19 vaccine side effects, study says (STAT)
• UnitedHealth’s surprising new target: Struggling Steward’s physician group (STAT)
• The U.S. needs a bipartisan industrial policy for the life sciences (STAT)
• Walgreens reports a $5.8B charge due to clinic operator VillageMD (Endpoints)
• Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending (Pink Sheet)
• Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations (MedTech Insight)