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A British charity is pledging roughly $154 million over the next five years toward research into treatments and diagnostics to improve cancer survival. Read More
The moment dietary supplement manufacturers start making specific curative claims, supplements are seen as drugs in the eyes of the FDA and require an IND, says a new guidance document. Read More
Drugmakers want the FDA to provide more details on how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More
The FDA is calling for risk management plans for clinical development of microbial vectors for gene therapy, focusing on the potential for vectors to germinate, regerminate or reseed. Read More
The European Medicines Agency announced a new drug pathway program that promises earlier, more extensive support for drugmakers researching new priority therapies to increase chances of taking them to market. Read More
A recent study published in JAMA Oncology found that lower income levels were linked to reduced participation in clinical trials for experimental cancer drugs. The results reinforce earlier findings from the same team, indicating that the disparity may be a trend and not an anomaly. Read More
Health care advocates and drugmakers are hoping to build patient engagement into an earlier, more integrated and standardized part of clinical trials, amid a torrent of patient-centric efforts taking over the industry. Read More
The FDA last month awarded $19 million in research grants to boost the development of products to treat 17 different rare diseases, many of which have little or no available treatment options. Read More
With additional training, reviewers at the FDA’s Center for Devices and Radiological Health have slashed the time it takes to get an IDE approved. Read More
The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiotics. Read More