Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
Akamis Bio Initiates Phase 1b FORTRESS Trial of NG-350A for Locally Advanced Rectal Cancer
• Akamis Bio has enrolled the first patient in its Phase 1b FORTRESS trial evaluating NG-350A in combination with standard chemoradiotherapy for locally advanced rectal cancer.
• NG-350A is a systemically administered immunotherapy designed to drive intratumoral expression of CD40 agonist antibodies, potentially enhancing immune response against both primary and metastatic tumors.
• The FORTRESS trial builds on promising results from the earlier CEDAR study, which showed significantly higher complete response rates when combining Akamis Bio's immunotherapy with standard chemoradiotherapy.
Akamis Bio Secures $60 Million for Cancer Gene Therapy Development and Partners with Xuanzhu Biopharma
Akamis Bio has successfully raised $60 million in Series A funding to advance its NG-350A gene therapy for cancer treatment. The funding, led by Sedgwick Yard, will support a Phase Ib clinical study in patients with locally advanced rectal cancer. Additionally, Akamis Bio has entered a licensing agreement with Xuanzhu Biopharma for the rights to NG-350A in Greater China, promising upfront payments, milestones, and royalties.
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