Peptide News Digest

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2 stories

Regulatory · View digest

Merck and Astellas Receive Positive CHMP Opinion for Keytruda Plus Padcev Before and After Surgery in Resectable Muscle-Invasive Bladder Cancer

Merck announced on Friday, September 18, 2026 that the CHMP recommended approval of Keytruda (pembrolizumab) with Padcev (enfortumab vedotin) as neoadjuvant treatment, continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer; the recommendation also covers subcutaneous Keytruda. In the Phase 3 KEYNOTE-B15 (EV-304) trial, the regimen reduced the risk of an event-free survival event by 47% and the risk of death by 35% versus gemcitabine and cisplatin chemotherapy plus surgery, and the pathologic complete response rate was 55.8% versus 32.5%. Merck said it would be the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for muscle-invasive bladder cancer regardless of cisplatin eligibility in the EU. A European Commission decision is expected by the fourth quarter of 2026, and the FDA approved the combination for this use in July 2026. Merck's partners on the regimen are Astellas and Pfizer.

Industry · View digest

Merck (MSD) Announces Friday July 24 Voluntary Licensing Agreements With Aspen Pharmacare (South Africa), Quality Chemical Industries (Uganda), and UCL Kenya in Sub-Saharan Africa Plus Aurobindo, Cipla, Emcure, and Viatris in India for Investigational Once-Monthly Oral HIV Prevention Pill MK-8527 (Alimatravir) Covering 129 Low- and Middle-Income Countries Including Every African Nation; Late-Stage Phase 3 Clinical Trial Results for Alimatravir Are Not Expected Until Late 2027

Merck (MSD) announced Friday July 24, 2026 seven voluntary, royalty-free, non-exclusive licensing agreements with generic drug manufacturers covering the investigational once-monthly oral HIV prevention pill MK-8527 (alimatravir). The licensees are Aspen Pharmacare (South Africa), Quality Chemical Industries (Uganda), and UCL Kenya in sub-Saharan Africa, plus Aurobindo, Cipla, Emcure, and Viatris in India. The territorial scope covers 129 low- and middle-income countries including every African nation. Alimatravir is an investigational late-stage once-monthly long-acting oral medicine for HIV-1 prevention, currently in Phase 3 development. Phase 3 topline results are not expected until late 2027. Alimatravir is designed to provide one month of protection from HIV-1 starting within one hour after dosing. Coverage frames the licensing structure as one of the broadest generic-access pre-approval commitments Merck has undertaken for an HIV asset. The announcement follows the April 7 STAT reporting that Merck's experimental HIV prevention pill could be made for less than $5 a year at manufacturing cost. Merck plans to file for regulatory approval in 2027-2028 with market launch dependent on Phase 3 outcome.