Recon: FDA approves Glaukos eye treatment; Merck to invest $70B in US research and manufacturing

• Kenvue Urges FDA to Reject Request for Autism Warning on Tylenol (Bloomberg)
• Merck to pour over $70 billion into US expansion (Reuters)
• US FDA approves Glaukos' new eye therapy (Reuters)
• US Congressional Budget Office lifts orphan drug cost estimate to $8.8 billion (Reuters)
• Replimune Soars as FDA Accepts Resubmitted Drug Application (Bloomberg)

• Congo’s last Ebola patient has been discharged, raising hopes that outbreak might be over (STAT)
• Roche suffers a fresh blow as India’s Supreme Court allows generic sales of its pricey rare disease drug (STAT)
• Clinical Trials To Thrive Under New WHO Global Network (Pink Sheet)
• EMA Slashes Average Clock-Stop Extensions By 18% To Speed Up Drug Reviews (Pink Sheet)
• Namibia Confirms First Mpox Case, Declares National Outbreak (Bloomberg)

• Veteran biotech executive Clive Meanwell on drug pricing and the obesity market (STAT)
• In its first clinical readout, Iambic shows early promise for AI-designed cancer drug (Endpoints)
• Merck rolls out some showstoppers at a major cancer conference. Its future may depend on them (STAT)
• With questions surrounding its gastric cancer drug, Amgen fills in some gaps (STAT)
• US FDA expands use of Amgen, AstraZeneca's drug for chronic inflammatory sinus disease (Reuters)
• AstraZeneca's Enhertu shows promise in early-stage breast cancer treatment (Reuters)
• Moderna co-founder Noubar Afeyan issues warning: Assault on science ‘isn’t going to stop at mRNA’ (STAT)
• RAPT, Jeyou are itching to start Phase 3 after encouraging mid-stage results in urticaria (Endpoints)
• Novartis seeks to move Pluvicto to earlier prostate cancer, but data underwhelm (Endpoints)
• Roche says ctDNA-guided Tecentriq prolonged survival in bladder cancer patients (Endpoints)
• Sanofi, Orano Med’s radiopharmaceutical looks competitive in rare cancer (Endpoints)
• Celcuity’s shares rally after ESMO readouts; Disc Medicine’s $220M stock sale (Endpoints)
• Weight management and primary care startup knownwell raises $25M (Endpoints)
• AbbVie's Rinvoq shows superiority over Humira in head-to-head arthritis study (Reuters)
• WeightWatchers partners with Amazon for easy weight-loss drug delivery (Reuters)
• AstraZeneca's Datroway extends survival in aggressive breast cancer (Reuters)
• Astra, Gilead Vie for Edge in Race to Treat Tough Triple-Negative Breast Cancer (Bloomberg)

• Duke data scientist launches startup to help hospitals adopt AI (STAT)
• Oura Prepares Apple Watch-Like Hypertension Detection for Its Smart Ring (Bloomberg)
• Dexcom faces proposed class action suit over G7 CGM problems (MedTech Dive)

• TikTok Diets Are Helping People When Medicine Can’t (Food Dive)
• RFK Jr. to unveil new guidance encouraging more saturated fats (The Hill)

• The radical democratization of academic medicine (STAT)
• Climate and health strategies must address the biodiversity crisis (STAT)