Ahead of Perjeta vote, impromptu survey of clinicians at ASCO Breast Cancer Symposium debate signals readiness to prescribe neoadjuvant drugs, based on pathological complete response data. ASCO President Clifford Hudis cautions of “serious risks to societal well-being with this approach.”
SAN FRANCISCO — An impromptu survey at the American Society of Clinical Oncology’s recent Breast Cancer Symposium showed strong support for using new drugs early, based on pathological complete response data as a surrogate for survival.
Held from Sept. 7-9 in San Francisco, the symposium drew over 930 attendees. Prospects for using new drugs soon after...
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
