FDA’s top drug official, responding to criticism about the high price of breakthrough drugs, said the agency is driving toward cures for diseases like cancer and hepatitis, but there will be a transition and possibly “a big down payment” required. Both FDA drug center Director Janet Woodcock and a research advocate played up the potential…
LONDON, April 17 (Reuters) – Scientists and drugmakers are pioneering a new kind of clinical trial that changes the way cancer drugs are studied, potentially cutting both the time and cost of bringing them to market. Instead of testing one drug at a time, a novel lung cancer study announced on Thursday will allow British…
Building on enthusiasm for the multi-sponsor, multi-drug clinical trial due to get underway in lung cancer soon, stakeholders in academia, industry, government and the patient community have begun discussions about a similar, biomarker-driven trial in colon cancer. The concept of a clinical trial “master protocol” is expanding into other disease areas even before the inaugural…
Draft guidance calls for a clear statement in the Indications and Usage section of labeling that reflects a drug’s clearance under accelerated approval on the basis of a particular surrogate or clinical endpoint. The document also includes provisions for reflecting the withdrawal of accelerated approval in labeling. FDA is proposing changes in the Indications and…
The vast majority of patients believe that pharmaceutical companies should provide services that complement the products they provide, whether they are taking long-term, short-term or lifestyle medications, a new US study has found. 76% of patients not only want such patient services but they expect them and look to pharmaceutical companies to be part of…
With the excitement about FDA’s breakthrough designation continuing to grow, patients now are looking to gain some influence over the process, although it is unclear how the agency would incorporate them. Sen. Michael Bennet, D-Colo., said he and other members of Congress are receiving letters from constituents and patients asking for a say in what…
In 16 years, cancer will become the leading cause of death in the United States, surpassing heart disease, according to a new report from the American Society of Clinical Oncology. The number of new cancer cases is expected to increase nearly 45% by 2030, from 1.6 million cases to 2.3 million cases annually. This influx of…
Some of the more exciting ideas in biotech are coming up in molecular diagnostics. There’s cool science at work. A number of tests have potential to cut down on overtreatment, reduce waste in healthcare, and give physicians clever new ideas on how to help patients. But this industry, which accounts for less than 2 percent…
In the summer of 2012, a year after his wife had died of lung cancer, Michael Harris scraped open an old mole on his back and it would not stop bleeding. The doctors said he had stage 4 melanoma, with a virtually inoperable tumor, and that patients in his condition typically lived about eight months. By…
Last year’s 39 NME approvals is not the “new normal,” Office of New Drugs Director John Jenkins declares. FDA approved just 27 NMEs in 2013. The return to normal also included a quiet December. For better or for worse, the number of new molecular entity approvals is the most widely cited statistic for gauging whether…
