Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Source:…
The FDA served U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing,…
The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Collegium Pharmaceutical of Canton, Massachusetts for downplaying the risks of its extended release opioid drug Xtampza ER in…
A federal judge ruled in favor of the FDA’s decision to deny Amgen market exclusivity for the pediatric dialysis drug Sensipar (cinacalcet), saying the company failed to prove the FDA…
Sponsors submitting NDA and BLA content for bioresearch monitoring inspections should list all relevant clinical sites and entities responsible for clinical study-related activities, according to new draft guidance from the…
FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes…
Achillion is handing out pink slips to 20 percent of its employees and initiating an operational restructuring plan. Source: BioSpace
New York-based Kallyope Inc. has secured an additional $66 million in Series B funding that it will use to continue its work harnessing the communicative pathways between the digestive tract…
Shares of Regeneron are down following reports of increased observations of known side effects from blockbuster drug Eylea were reported by providing doctors. Source: BioSpace
GW Pharmaceuticals announced that its pipeline compound GWP42006 failed to meet its primary endpoint in a Phase IIa proof of concept study for patients with focal seizures. Source: BioSpace