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FDA Grants Fast Track Designation for MimiVax’s SurVaxM
The vaccine is targeting newly diagnosed glioblastoma.
MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, announced in a company press release that the FDA has granted fast track designation (FTD) to MimiVax's SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma (nGBM). MimiVax is focused on completing the Phase IIb survive study and securing funding necessary to bring SurVaxM through the FDA approval process.
"The receipt of fast track designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," said Michael Ciesielski, CEO, MimiVax. "This designation is a key component in our journey to help patients with glioblastoma to live longer."
Reference: MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma. PR Newswire. October 12, 2023. Accessed October 13, 2023. https://www.prnewswire.com/news-releases/mimivax-granted-fast-track-designation-from-fda-for-survaxm-for-newly-diagnosed-glioblastoma-301954795.html
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
