With the consequences of the delayed response to the Ebola crisis still fresh on their minds, members of a House subcommittee Wednesday stressed the need to step up U.S. preparedness for bioterrorism attacks.
Reflecting its "current thinking," the FDA released final guidance Tuesday on efficacy endpoints for clinical trials of non-small-cell lung cancer (NSCLC) drugs.
In denying the eighth citizen petition filed by Teva Pharmaceutical Industries Ltd. to protect its blockbuster multiple sclerosis (MS) drug Copaxone from generic competition, the FDA followed a hard and fast regulatory line distinguishing complex nonbiologics from biologics.
While breakthroughs in cancer treatments tend to come in incremental steps, payers in the U.S. cannot continue to pay breakthrough prices for incremental improvements in cancer drugs, two scientists with the National Cancer Institute (NCI) said after finding no rationale for the hefty prices of new cancer drugs.
The FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9-2, with one abstention, Wednesday to recommend approval for The Medicines Co.'s (MDCO) cangrelor, but the panel's love for the drug wasn't much lovelier the second time around.
As health care across the globe shifts to a more patient-focused model, one of the challenges is getting patients to be more accountable for their own health.
Reports of a myeloma patient and her family being kicked off an airplane this week highlight some of the problems with turning patient-expressed needs into science-based assessments that can be used to measure endpoints in clinical trials for new drugs and devices.
Responding to its eighth FDA warning letter in seven years, Hospira Inc. has committed to working with a third-party consultant to conduct a comprehensive assessment of its manufacturing, laboratory and quality operations.