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

ReconRecon | 29 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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 2nd 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 1st biopharma startup (Fierce)
Government, Regulatory & Legal
  • Merck Fends Off Patent Challenge to Diabetes Treatment (Bloomberg)
  • Novartis Gets Entresto Counterclaims by Hetero, Torrent Tossed (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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