Directory Category: BioManufacturing

Cidara Therapeutics Doses First Patient in Pivotal Phase 3 ReSPECT Trial of Rezafungin for Prevention of Invasive Fungal Disease in Patients Undergoing Allogeneic Blood and Marrow Transplantation

SAN DIEGO, Calif. & CAMBRIDGE, England, May 20, 2020 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, and Mundipharma today announced that the first patient has been dosed in its ReSPECT pivotal Phase 3 clinical trial evaluating the efficacy and safety of the companyís lead antifungal candidate, rezafungin, for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections.

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UK Medicines and Healthcare Products Regulatory Agency (MHRA) Issues an Early Access to Medicines Scheme (EAMS) Positive Scientific Opinion for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations

Feltham (Merck) – Merck announced today that the UK Medicines and
Healthcare Products Regulatory Agency (MHRA) has issued an Early Access
to Medicines Scheme (EAMS) positive scientific opinion for tepotinib
for the treatment of adult patients with advanced Non-Small Cell Lung
Cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene
(MET) exon 14 (METex14) skipping alterations.

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