Peptide News Digest

#Msd

2 stories

Regulatory · View digest

Merck (MSD) and Astellas Secure Positive EU CHMP Opinion for Keytruda (Pembrolizumab) + Padcev (Enfortumab Vedotin-Ejfv) as Perioperative Treatment in Resectable Muscle-Invasive Bladder Cancer Based on Phase 3 KEYNOTE-B15/EV-304

Merck (NYSE: MRK; MSD outside North America) and Astellas (TSE: 4503) announced Friday September 18, 2026 that the EMA's CHMP issued a positive opinion recommending EU marketing authorization for Keytruda (pembrolizumab, anti-PD-1 monoclonal antibody) in combination with Padcev (enfortumab vedotin-ejfv, Nectin-4-directed antibody-drug conjugate developed with Pfizer) as perioperative treatment — neoadjuvant before radical cystectomy, continued as adjuvant — for adults with resectable muscle-invasive bladder cancer (MIBC). The recommendation is based on Phase 3 KEYNOTE-B15/EV-304 data documenting statistically significant improvements in event-free survival (primary endpoint), overall survival, and pathologic complete response rate versus neoadjuvant cisplatin-based chemotherapy followed by adjuvant standard of care. European Commission decision is expected in Q4 2026. This would be the first perioperative regimen combining a PD-1 inhibitor with an antibody-drug conjugate to reach European regulatory approval in MIBC and follows the September 2026 FDA approval of the same regimen (plus KEYTRUDA QLEX subcutaneous formulation with berahyaluronidase alfa-pmph) for cisplatin-ineligible MIBC patients.

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.