By ALAINA BUSCH FDA granted another breakthrough drug designation, bringing the total to two, while also denying one of the seven designation requests received since the new program was enacted in the FDA Safety and Innovation Act, agency officials said this week. FDA officials emphasized the need for designation requests to include clinical data, a requirement…
By ALAINA BUSCH FDA granted another breakthrough drug designation, bringing the total to two, while also denying one of the seven designation requests received since the new program was enacted in the FDA Safety and Innovation Act, agency officials said this week. FDA officials emphasized the need for designation requests to include clinical data, a requirement…
By MICHAEL MCCAUGHAN FDA officials are eager to experiment with “master trial” protocols to allow simultaneous studies of multiple targeted oncology therapies as an alternative to traditional, single-agent registrational studies. An issue brief proposing a design for a multi-drug registration trial in metastatic non-small cell lung cancer was discussed during a Friends of Cancer Research/Brookings conference…
By DENISE GRADY Emma Whitehead has been bounding around the house lately, practicing somersaults and rugby-style tumbles that make her parents wince. It is hard to believe, but last spring Emma, then 6, was near death from leukemia. She had relapsed twice after chemotherapy, and doctors had run out of options. Desperate to save her,…
By DENISE GRADY Emma Whitehead has been bounding around the house lately, practicing somersaults and rugby-style tumbles that make her parents wince. It is hard to believe, but last spring Emma, then 6, was near death from leukemia. She had relapsed twice after chemotherapy, and doctors had run out of options. Desperate to save her,…
By JENNIFER CORBETT DOOREN The Food and Drug Administration is on track to approve more than 30 new drugs this year—the most in eight years—partly because the pharmaceutical industry is speeding development of experimental drugs. As of the end of November, the agency approved 31 new types of drugs for diseases including cancer, multiple…
By JENNIFER CORBETT DOOREN The Food and Drug Administration is on track to approve more than 30 new drugs this year—the most in eight years—partly because the pharmaceutical industry is speeding development of experimental drugs. As of the end of November, the agency approved 31 new types of drugs for diseases including cancer, multiple…
By PUNEET OPAL This time of year, trainees make the rounds to interview for graduate programs, medical school, and residency or fellowship positions. In many cases, they spend a decade or more after college before they can move on to independent careers in academia or industry. As a director of the Physician Scientist Training Program at Northwestern,…
By PUNEET OPAL This time of year, trainees make the rounds to interview for graduate programs, medical school, and residency or fellowship positions. In many cases, they spend a decade or more after college before they can move on to independent careers in academia or industry. As a director of the Physician Scientist Training Program at Northwestern,…
By ANNA EDNEY Four experimental cancer treatments that may one day help gravely ill children are facing review by U.S. pediatric advisers who have been working for years to find ways to develop more drugs for this underserved population. The medicines from GlaxoSmithKline Plc (GSK), Amgen (AMGN) Inc., Threshold Pharmaceuticals Inc. (THLD) and Boehringer Ingelheim…
