Good morning, everyone, and how are you today? We are doing just fine, thank you, despite the cloudy skies looming over the Pharmalot campus. After all, the birds are still chirping and a cool breeze is wafting by. Moreover, this marks the middle of the week, which means we have managed to survive this far. And this calls for celebration, yes? So please join us as we hoist another cup of delicious stimulation. Our choice today is vanilla macadamia nut. Remember, no prescription is required, and so no rebates are applied. Meanwhile, here are a few items of interest. Have a grand day and drop us a line if you hear something saucy …
The U.K. Medicines and Healthcare products Regulatory Agency announced sweeping changes to regulations governing clinical trials, Pharmaphorum explains. Among the changes will be a facility to run regulatory and ethics reviews of clinical trial applications in parallel and to reduce the time it takes to get a study up and running. The agency also proposed a maximum 30-day period to review new trial applications, and a maximum of 10 days after the receipt of additional requested information. The plan also includes a legally binding requirement to register new trials in a World Health Organization public register and provide results within 12 months of completing a study.
Meanwhile, Novartis is scrapping a high-profile U.K. clinical trial once touted as an example of National Health Service collaboration, even as the government tries to smooth the path for other studies and restore the country’s status as a destination for groundbreaking research, Bloomberg News reports. The drugmaker decided not to proceed with a study announced in early 2020 as part of a broader cooperation with the U.K. government to get a new heart drug to patients. Instead, Novartis this month started an international trial of people with the same profile, which will include sites in the U.K.
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