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The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report.
With the COVID-19 public health emergency ending in the U.S. next week, Congress is looking to use the lessons learned from the pandemic to draft a new iteration of the Pandemic and All-Hazards Preparedness Act to ensure the country is better prepared for the next pandemic.
While sorting out a second phase III study design for its cancer therapy and light device with the U.S. FDA, Soligenix Inc. produced positive results from a compatibility study evaluating Hybryte (synthetic hypericin sodium) for treating early stage cutaneous T-cell lymphoma (CTCL). That data, according to Soligenix, bolster findings from the phase III FLASH study, which used the same combination in treating CTCL. According to Christopher Schaber, Soligenix CEO, the important corporate objectives for the compatibility study were to replicate results seen in the FLASH study.