At a workshop sponsored by the Duke-Margolis Center for Health Policy last week, representatives from the FDA, academia, industry and patient groups sat down to discuss the potential use of minimum residual disease (MRD) as a surrogate endpoint for hematologic malignancies.
Since the FDA's breakthrough therapy designation came into existence as part of the FDA Safety and Innovation Act in July 2012, the agency has granted the designation to 145 drugs.
Since the FDA's breakthrough therapy designation came into existence as part of the FDA Safety and Innovation Act in July 2012, the agency has granted the designation to 145 drugs.
Genomic sequencing offers great hope for patients to treat their disease in the most specific way possible through precision medicine. But the new frontier in medicine isn't very helpful for patients with diseases that don't have known links to genetic mutations.
Small companies often avoid the heart drug market, staying clear of the waters typically traversed by larger drugmakers who are more able to handle the risk associated with the larger and longer clinical trials required.
Earlier this month, Shire plc gained FDA approval for Xiidra (lifitegrast), the first drug approved for dry eye disease since Allergan Inc.'s Restasis (cyclosporine) was approved 14 years ago.
In the first quarter of 2016, private U.S. biopharmas tracked by BioWorld Snapshots raised about $380 million less than the same quarter in 2015, but the year-over-year decline was easy to shrug off because the first quarter of 2015 contained a monster $450 million series C round by Moderna Therapeutics Inc.
Diabetes drugs have come a long way from meta-analyses from Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, and others suggesting that Avandia (rosiglitazone, Glaxosmithkline plc) was increasing the risk of cardiovascular (CV) problems.
