The once-hypothetical question of reimbursability is now leading the global partnering conversation, but how can anyone know whether a preclinical molecule will differentiate itself enough down the road to provide value for payers? The reality of partnering conversations these days is that reimbursement is becoming a bigger consideration than science, particularly with the influence of…
WASHINGTON — The federal government has continued to enroll critically ill people in clinical trials at the National Institutes of Health since the government shutdown began last week, but the pace has slowed drastically, and many other sick people are having to wait for treatment. As elected officials try to sway public opinion on which party bears…
WASHINGTON, DC—The advocacy organization Friends of Cancer Research (FOCR) released a new blueprint document at a forum here designed to improve and expedite the approval process for drugs given the Food and Drug Administration’s Breakthrough Designation, along with companion diagnostic tests. Currently, the development of a companion diagnostic may lag behind the accelerated review timeline…
In 2006 when doctors started testing a melanoma treatment made by Roche Holding AG on patients, they were used to facing slim odds – about one in eight – that the tumors would shrink on chemotherapy. This time, they couldn’t believe their eyes. With Zelboraf, a drug that targets specific mutations in cancer cells, eight…
Analysis of meetings in FDA’s public calendar indicates Commissioner Hamburg, other senior leaders continue to attend meetings throughout the U.S. and overseas; stakeholders worry sequester-induced travel cuts prevent rank-and-file scientists from attending helpful events. FDA Commissioner Margaret Hamburg lamented the toll sequestration has taken on her agency’s travel budget during the keynote speech she gave…
Nearly every oncologist can tell the story of cancer patients who beat the odds, responding so well to treatment that they continued to live many years disease-free, while most of their peers worsened and eventually died. Dr. David Solit decided to find out why. Solit, an oncologist at Memorial Sloan-Kettering Cancer Center in New York…
In August I had the pleasure of participating in Fierce’s “Understanding Major Regulatory Change” webinar. This session was about the FDA’s new “Breakthrough Therapy” designation, and I was joined by Dr. Jay Siegel from Johnson & Johnson ($JNJ) and James Pierce from Appian Corporation for a lively discussion. In case you missed it, you…
Cancer treatment has grown so complex, many U.S. doctors can’t keep up with new information and are offering incorrect treatment, failing to explain options and leaving patients to coordinate their own care, according to a report released on Tuesday by the Institute of Medicine, part of the National Academy of Sciences. The 315-page report, “Delivering…
The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. FDASIA section 902 provided for a new designation, the breakthrough therapy designation, for new drugs. Since last July, the agency has received a total of 82 applications for the designation, and has published a draft guidance…
In his first-floor office in the main building of the National Institutes of Health, Dr. Francis Collins, the director of the institutes, has hung a series of framed pictures. Placed in two equal-length rows of three pictures, they show him sharing the stage with President Barack Obama, talking with Senate Majority Leader Harry Reid (D-Nev.),…
