Recon: FDA approves Sanofi’s RSV monoclonal antibody for infants and high-risk children; Eli Lilly to acquire Versanis for $1.93B

• FDA approves RSV monoclonal antibody for infants, young children at high risk (STAT) (FDA)
• Eli Lilly expects FDA decision on Alzheimer’s drug by end of year as it unveils full PhIII data (Endpoints) (Reuters) (Fierce) (STAT)
• FDA Action Alert: Verrica, Citius and Daiichi Sankyo (BioSpace)
• Catalent’s Indiana site, linked with Regeneron’s high-dose Eylea rejection, dinged with 3 FDA observations (Fierce) (Endpoints)
• House greenlights psychedelic research in NDAA, drug shortage and PBM reforms to come (Endpoints)
• GAO offers 11 new policies to improve regenerative medicine development in new report (Endpoints)
• US FTC seeks additional info on Pfizer's proposed takeover of Seagen (Reuters)

• Pfizer’s $43 Billion Seagen Takeover Faces EU Investigation (Bloomberg)
• EMA Fee Proposals Pass Another Legislative Milestone (Pink Sheet)
• EMA To Get Tough On Companies That Repeatedly Delay New Marketing Applications (Pink Sheet)
• UK's life sciences sector sees $1.1B drop in foreign investments from 2021 to 2022 (Endpoints)
• Britain lagging in delivery of new hospitals, watchdog says (Reuters)

• Eli Lilly to buy Versanis for up to $1.93 billion in obesity drugs push (Reuters) (STAT)
• BridgeBio heart disease drug vindicated with phase 3 victory, plots FDA submission this year (Fierce) (Reuters) (STAT)
• Novartis pays $500M to fly DTx’s FALCON platform, 3 preclinical neuroscience programs (Fierce) (BioSpace)
• Eli Lilly's Prevail strikes potential billion-dollar AAV capsids deal with Sangamo for neurological diseases (Endpoints)
• Acumen's Alzheimer's drug passes initial safety test (Reuters)
• Argenx antibody drug significantly slows progression of nerve disorder that robs patients of muscle strength (STAT) (Bloomberg)
• Sanofi licenses CRISPR enzyme in bid to develop safer, simpler sickle cell cure (STAT)
• Novo Nordisk turns RNA research up to Eleven with new biotech pact (Fierce)
• Apellis shares tumble on reports of eye inflammation in patients taking Syfovre (Endpoints)
• J&J touts Rybrevant win in newly diagnosed lung cancer, with key Tagrisso head-to-head readout up next (Fierce)
• Exclusive: MoonLake Immunotherapeutics explores sale, sources say (Reuters)
• Novo Nordisk set to boost Wegovy supplies with second manufacturer ready, and a third getting closer (Endpoints)
• Alzheimer's diagnosis revamp embraces rating scale similar to cancer (Reuters)
• Scientists turn CRISPR scissors to genes involved in Alzheimer’s (Fierce) (Endpoints)

• QuidelOrtho’s recall of potentially faulty heart attack blood tests lands FDA Class I tag (Fierce) (STAT)
• FDA provides safety update on hernia repair mesh as medtech companies face lawsuits (MedTech Dive)
• BD warns of 8 cybersecurity flaws in Alaris infusion pump systems (Fierce)
• What the new CMS payment proposals mean for device makers (MedTech Dive)
• Grail sued by 3 women over alleged ‘frat house’ culture, harassment and retaliation (Fierce) (STAT)
• Court allows Axonics neurostim patent case to proceed against Medtronic (MedTech Dive)
• AdvaMed says CMS radiotherapy rate cut proposal will limit patient access (MedTech Dive)
• ‘Closest To What The Pancreas Would Actually Do’: Medtronic Diabetes Execs On Marketing Plans For MiniMed 780G (MedTech Insight)

• Novartis faces one win, one loss in patent cases over blockbuster heart failure drug (Endpoints)
• Roche sues Biogen over biosimilar of blockbuster arthritis drug (Reuters)
• Endo’s Creditors Oppose ‘Shortcut’ $6 Billion Bankruptcy Sale (Bloomberg)
• Biopharma Lawsuit Tracker 2023: Roche Sues Biogen Over Patent Infringement (BioSpace)
• McKesson Price Scandal Suit Ends With $141 Million for Investors (Bloomberg)