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FDA Grants Fast Track Designation to Polycythemia Vera Treatment
The drug, 9MW3011, is also approved for clinical study by NMPA.
Mabwell announced that its polycythemia vera treatment has been granted fast track designation by FDA.
The designation expedites the review process and can help get valuable new treatments to patients at a faster pace.
In a press release, Mabwell noted that 9MW3011 has also been approved for clinical study in China by NMPA, and the first patient to receive a dose in a clinical study occurred in March 2023.
The drug inhibits the absorption and release of iron, lowers sodium levels, and can upregulate the level of hepcidin expressed by hepatocytes.
Source
(Sept. 22, 2023); Mabwell; FDA Grants Fast Track Designation to 9MW3011; https://mabwell.com/en/news_info/id-116.html
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
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.
