Recon: FDA approves Sanofi’s Dupixent for rare skin disorder; Eisai, Biogen announce positive Phase III results for Alzheimer’s drug

• Sanofi/Regeneron’s Duxipent Scores First US Approval for Prurigo Nodularis (Biospace) (Bloomberg)
• Former Novartis drug for ultra-rare disease gets speedy FDA review (Endpoints)
• Alzheimer's drug study yields positive results, say makers Eisai and Biogen (Reuters) (Fierce) (Pink Sheet)
• CMS as gatekeeper: Why lecanemab is similar but also very different from Aduhelm (Endpoints)
• Lecanemab And Medicare: Could Better FDA/CMS Communication Improve Coverage Chances? (Pink Sheet)
• Analysis: Alzheimer's drug trial breakthrough boost for Roche, Eli Lilly (Reuters)
• Gilead widens battle against alleged counterfeit HIV drug ring (Reuters)
• Opioid crisis cost U.S. nearly $1.5 trillion in 2020 -congressional report (Reuters) (Bloomberg)
• Early data suggests monkeypox vaccine may be working, CDC says (Politico)
• U.S. CDC expands pre-exposure eligibility for monkeypox vaccine (Reuters)
• Drug Price Law to Spur Creative Claims as Industry Readies Fight (Bloomberg)
• US FDA Heightens Focus On Cannabis With Hiring Of Norman Birenbaum As Public Health Advisor (Pink Sheet)
• What more can we learn from DTC advertising? FDA's OPDP proposes new research (Endpoints)
• Aligos co-founders shoot back at J&J IP complaint with one of their own alleging fraud (Endpoints)

• EU To Kick Off ‘Joint Action’ On Tackling Drug Shortages (Pink Sheet)
• EU Drafts Recommendations On Identifying Suitable RWD Sources For Studies (Pink Sheet)
• As winter approaches, a European generics group raises alarm over energy prices for manufacturers (Endpoints)
• China Walvax's mRNA COVID vaccine obtains first approval overseas (Reuters)
• Merck agrees to allow Sinopharm to sell molnupiravir COVID drug in China (Reuters)
• China Ban on Lab Monkey Exports Hurts Vaccine, Drug Development (Bloomberg)
• Pandemic Treaty: WHO To Broadcast Videos Of Stakeholders ‘Wishlists’ (Pink Sheet)
• Brazilian HTA To Adopt Cost-Effectiveness Thresholds (Pink Sheet)
• Ebola kills five in Uganda, 19 other deaths likely connected, president says (Reuters)

• Novo enters NLRP3 arena, paying Ventus $70M got NASJ hopeful (Fierce) (Biospace)
• Novartis’ Sandoz sells Chinese finished drugs plant to CDMO Jiuzhou for $15.1M (Fierce)
• New Jersey biotech nets $50M+ BARDA contract for respiratory candidate (Endpoints)
• J&J debuts Kenvue as new name for $15B consumer health business spinoff (Endpoints)
• With rivals on its heels, Illumina launches a new line of high-end DNA sequencers (STAT)
• Another Avastin biosimilar joins the party as Roche's grip on the market loosens (Endpoints)
• With cash dwindling, Axcella shares look at blinded NASH data (Fierce) (Endpoints)
• Idera Bolsters Rare Disease Portfolio with Aceragen Buyout (Biospace)
• Meliora Therapeutics Raises $11M Seed Financing to Develop First Mechanism of Action Atlas in Oncology (Biospace)
• Out of Context: CEO says now not the time to build a ‘big independent biotech’ (Fierce)
• Fierce Biotech Layoff Tracker: Exicure cuts staff for 2^nd time in ’22, Palisade slashes 20% of staff (Fierce)

• Industry Welcomes Changes To EU AI Act, But Fears Of Overlap Remain (MedTech Insight)
• FDA clears Medtronic’s powder-to-gel bloodstopping spray for upper GI bleeds (Fierce)
• Liquid Biopsy Revolutionizing Cancer Care, But Costs Continue To Inhibit Global Potential (MedTech Insight)
• Pfizer, AstraZeneca, Merck KGaA-backed Israeli incubator launches 1^st biopharma startup (Fierce)

• Merck Fends Off Patent Challenge to Diabetes Treatment (Bloomberg)
• Novartis Gets Entresto Counterclaims by Hetero, Torrent Tossed (Bloomberg)