It has been deemed one of the most controversial drug approvals in recent history, but when the FDA approved Sarepta Therapeutics’ Exondys 51, on the 19th of September, 2016, Duchenne muscular dystrophy (DMD) patients, their [...]
If you do nothing else today, check out this link. It provides letters from real people talking about three areas of the US healthcare system which stand to benefit from the 21st Century Cures Act. [...]
Proponents of the 21st Century Cures Act believe that, once the Bill becomes law, countless Americans across all age groups, disease spaces, and socio-economic backgrounds, will stand to benefit. This will certainly be the case for cancer patients and their families, as the Bill promises to invest $1.8 billion dollars into Vice President Joe Biden’s Cancer Moonshot program. ...Read More
In order for a manufacturer to sell its drug on the market, it will have to receive a valid license from the US Food and Drug Administration (FDA), or the equivalent review board in countries outside the US. This license will specify exactly how the medicine should be used and what patients are allowed to use it ...Read More
In September of 1990, the first gene therapy clinical trial approved for use in a human was carried out, led by American physician, W. French Anderson, MD. It was an exciting time for scientists, patients, and pharmaceutical companies, all of which were poised to benefit from this new and exciting scientific discovery ...Read More
When transporting temperature-controlled comparator drugs for clinical trials, it is important to maintain the integrity of the product so as to avoid any problematic temperature deviations. Although it is near impossible to avoid deviations entirely, trial sponsors can keep them to a minimum by choosing an appropriate shipping method for their transportation needs ...Read More
The updated version of the 21st Century Cures Act was approved by the House on Wednesday, the 30th of November, and it is expected to have similar success in the Senate vote next week ...Read More