The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.
The lack of a comprehensive regulatory pathway has not hindered Chinese researchers from forging ahead with the world's first human clinical study using CRISPR-Cas9 gene editing technology, which will be used to treat advanced lung cancer.
Disclosure UK, a new database requiring pharma companies to declare payments made to healthcare professionals, will record any payments made by companies to UK healthcare professionals for attending continuing professional development events, associated travel and hospitality costs, and any payments for work as advisers or consultants to companies.
Additional safety measures including a possible sales suspension are to be discussed by a review committee in South Korea on Oct. 4 that will help decide the fate of Hanmi’s EGFR inhibitor olmutinib. Financial authorities in the country are also launching a probe into the timing of the disclosure of several cases of serious adverse events with the drug.
The French committee investigating the data behind the Phase I study of Bial's FAAH inhibitor BIA 10-2474, which resulted in the death of one volunteer and the hospitalization of five others in January 2016, has made a number of recommendations for tightening up the regulations on first-in-human studies.
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