Oncology

FDA Unveils Second Wave of National Priority Voucher Winners, Featuring Obesity Leaders Lilly and Novo Nordisk

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FDA unveils second wave of National Priority Voucher winners, featuring obesity leaders Lilly and Novo Nordisk

Scientists and staff walk outside the U.S. Food and Drug Administration headquarters, representing the agency’s growing focus on regulatory innovation and public health priorities. (AI-generated for editorial illustration purposes.) FDA expands National Priority Voucher pilot with six new awardees, bringing total to 15 therapies The U.S. Food and Drug Administration (FDA) has announced a significant … Read more

Reimbursement Series: CMS and Europe Reimbursement Pathway Accelerates Innovation

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CMS and Europe reimbursement pathway

In a transformative week for market access, the CMS and Europe reimbursement pathway expansion delivered several pivotal coverage and pricing decisions reshaping patient access across cardiovascular, hepatic, and oncology therapies. From CMS’s national determinations on breakthrough devices to European HTA approvals in rare disease and cancer, these developments underscore a growing transatlantic alignment between regulators … Read more

Innovent’s IBI363 Gains Second China BTD for Resistant Lung Cancer

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China’s National Medical Products Administration has granted a second Breakthrough Therapy Designation to Innovent Biologics’ IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, for treating immunotherapy-resistant squamous non-small cell lung cancer (sqNSCLC). The designation applies to unresectable, locally advanced, or metastatic sqNSCLC that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy. This marks IBI363’s fourth … Read more