Recon: GSK to pay $1 billion for exclusive rights to hepatitis B drug; Another Finnish notified body designated under IVDR

• Sarepta’s Duchenne gene therapy fails to meet primary endpoint in pivotal trial (STAT)
• As Sarepta execs talk up Duchenne confirmatory trial results, investors and analysts remain divided on how flexible FDA will be (Endpoints)
• Tracking the FDA advisory panel on the first CRISPR-based treatment for sickle cell disease (STAT)
• On the eve of Halloween, the FDA weighs whether medicine should ever taste like candy (STAT)
• GSK to pay $1 bln for exclusive license to J&J's hepatitis B therapy (Reuters)
• FDA lifts clinical hold on Mersana’s STING agonist, PhI starting dose lowered after patient death (Endpoints)
• FDA posts updated safety data on Bayer’s Essure, notes progress on improving study (MedTech Dive)

• Belgium seizes fake weight-loss drugs containing insulin (Reuters)
• As India grows its biologics market, Aragen builds new $30M facility (Endpoints)
• Cardiology And Biomarker Opportunities In Next Funding Round Of EU's IHI (MedTech Insight)
• Second Finnish Notified Body To Be Designated Within Two Months Under The EU IVDR (MedTech Insight)

• Eli Lilly to pay $200 million for Beam’s share of drugs from gene-editing firm Verve (STAT)
• Bluebird bio to sell sickle cell FDA voucher for $103 mln if therapy approved (Reuters)
• How skeptical should you be of an after-the-fact subgroup analysis in a failed clinical trial? (STAT)
• Cassava pulled back the curtain on its Alzheimer’s study — and revealed insurmountable problems (STAT)
• Pfizer looks beyond COVID as Paxlovid charge sparks swing to quarterly loss (Reuters)
• Amgen sales rise, but shares off as investors await obesity data (Reuters)
• Galera considers 'strategic' options; Novo partners with French biotech; AnHeart gets $40M (Endpoints)
• Local pharmacies say they're struggling to afford GLP-1s (Endpoints)
• Engine Biosciences bags $27M Series A extension to advance precision medicine platform in oncology (Endpoints)

• Revvity cuts annual forecast on weak demand for diagnostics, contract research (Reuters)
• GE HealthCare beats quarterly profit estimates on imaging device demand (Reuters)
• Ametek raises profit outlook, buys Paragon Medical in $1.9 bln deal (Reuters)
• Global digital health funding hits its lowest level in almost a decade (Endpoints)
• Tracking Philips Respironics recalls (MedTech Dive)
• Senseonics See Few Barriers To Adoption For Their Implantable CGM (MedTech Insight)
• News We're Watching: TCT Yields More Encouraging Results For TAVR; HeartPoint Resets Trial Plans, Butterfly Tries Brain-Interface Tech (MedTech Insight)

• GSK, Ancestry, 23andMe Push Montana Genetic Privacy Law Changes (Bloomberg Law)
• DEA Updates Special Surveillance List of Precursor Chemicals and Equipment (FDA Law Blog)
• The FTC Complaint Is Fully Visible. The COVID-19 'Mask' Is Not. (MedTech Insight)