Recon: FDA approves Guardian’s blood-based cancer test; Boehringer to acquire biotech Nerio for $1.3B

• RSV vaccine makers vying for market share in second year of shots (Reuters)
• Guardant's blood-based cancer test moves closer to Medicare coverage with FDA approval (Reuters) (STAT)
• Pharma companies less concerned after hearing from US on negotiated prices for Medicare (Reuters)
• Sarepta demanded Duchenne patient advocacy group censor video critical of the company (STAT)
• FDA's ad enforcer critiques Brittany Mahomes' paid Instagram post for Kaléo (Endpoints)
• Pfizer cuts 210 North Carolina workers after it officially discontinues failed Duchenne gene therapy (Endpoints)

• Drugmaker Sinergium to share bird flu vaccine data globally, says WHO (Reuters) (WHO)
• Shares of Japan's Eisai tumble after EU rejects Alzheimer's drug (Reuters)
• Cost savings drive Philips' profit beat, flags insurance payout (Reuters)
• Roche to fast-track weight loss drugs to compete with rivals, FT reports (Reuters)
• EU regulator backs use of GSK's RSV shot in adults aged 50 to 59 (Reuters)
• Boehringer inks $1.3B acquisition of Nerio and its preclinical checkpoint inhibitors (Fierce)

• Pharma aims to deliver personalized cancer therapies more quickly (Reuters)
• How Pfizer’s grand gene therapy ambitions crumbled (STAT)
• GSK leans on Flagship for help finding new drugs, vaccines (BioPharmaDive)
• WuXi AppTec sees US revenue decline amid Biosecure threat (Endpoints)
• FDA places vTv's lead diabetes drug on hold over chromatographic signal (Fierce)
• PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion (Pink Sheet)
• Collegium pays $525M to buy ADHD company; FDA delays Syndax decision (Endpoints)
• NewAmsterdam succeeds in the first of three key pivotal studies, providing hope to a troubled cardio class (Endpoints)
• AstraZeneca’s fixed-duration Calquence combo succeeds in Phase 3 blood cancer test (Endpoints)
• Roivant's dealmaker lands $81M cash bonus following drug sale to Roche (Endpoints)
• After tense standoff, AstraZeneca and Daiichi's Enhertu turned away by NICE on pricing grounds (Fierce)
• Anavex’s new analysis of its Alzheimer’s pill shows mixed results (Endpoints)
• Cognition Therapeutics' stock sinks on Phase 2 Alzheimer’s data (Endpoints)
• Ventyx axes development of TYK2 inhibitor following Phase 2 failure (Endpoints)
• Australia Prioritizes GMP-Compliant Manufacturers For Shorter Inspections (Pink Sheet)
• Shingles vaccine may help delay dementia – study (BBC)
• New cardiovascular risk model could greatly decrease use of statins and increase heart attacks, study warns (STAT)

• Revvity raises 2024 profit forecast on medical equipment demand; shares rise (Reuters)
• Abbott shares slide after trial verdict, weigh on rival Reckitt Benckiser (Reuters)
• Dexcom plunges as revenue forecast cut spooks investors (Reuters)
• Tandem CMO shares Mobi feedback, expansion plans (MedtechDive)
• Two High-Profile Members Of Newly Elected European Parliament Have Valuable Medtech Expertise (MedtechInsight)

• Abbott must pay $495 million in premature infant formula trial, jury finds (Reuters)
• With J&J pushing a 3rd talc bankruptcy, court affirms earlier loss (Reuters)
• Indivior To Pay $86M To Settle Opioid Claims By 5 States (Law360)