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…
FDA data requirements supporting novel drug approvals vary widely, depending on therapeutic area, with cancer drugs given greatest leniency, suggesting products may need a clinical trial “quality grade,” according to an analysis published in the Journal of the American Medical Association. Another study shows cancer treatments are most likely to get approved on the…
FDA Office of Hematology & Oncology Products Director Richard Pazdur, MD, sat down to discuss the state of cancer R&D, Breakthrough therapies, and how his staff pushes to complete those speedy three-month reviews during The RPM Report’s FDA/CMS Summit for Biopharmaceutical Executives in December. Here is a transcript of the conversation, edited for clarity. Q: Oncology…
When the I-SPY 2 trial launched in 2010, oncologists heralded it as the future of cancer research. Five pharmaceutical companies put aside their differences to participate in the landmark phase 2 breast cancer trial, which adaptively and efficiently randomized patients to one of seven experimental therapies. Now, even as I-SPY 2 propels its first two…
A few years ago, when Michel Sadelain spoke about adoptive cell transfer (ACT) therapy at cancer meetings, his colleagues were dubious about what seemed a drastic and unconventional approach: harvesting and genetically altering his patient’s immune cells to train them to attack her cancer. “I can’t tell you how many nearly empty rooms I’ve spoken…
