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An FDA advisory committee voted in favor of ARS Pharmaceuticals’ neffy (ARS-1), an intranasal epinephrine spray, as an alternate to epinephrine injection for severe anaphylactic allergic reactions despite the absence of clinical data. Read More
Four bills aimed at encouraging drug development and controlling costs survived markup by the Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday, lining them up for consideration and vote by the full chamber. Read More
The FDA’s approval of Otsuka Pharmaceutical’s Rexulti (brexpiprazole) to treat agitation in people with Alzheimer’s disease (AD) makes it the first drug approved for this indication, reported in approximately half of people with AD. Read More
A U.S. District Court in Illinois has ordered Eli Lilly to pay triple damages — $183.7 million — for violating the False Claims Act by underpaying rebates to Medicaid. Read More
This month has started strong with the May 11 approval of Rexulti to treat agitation in Alzheimer’s dementia, the only drug approved to treat this common Alzheimer’s symptom. Read More
Senators from both sides of the aisle pressed insulin makers and pharmacy benefit managers (PBM) on the drug’s high cost during a committee hearing Wednesday, where the two groups accused each other of driving up costs and lawmakers often appeared baffled by the opaque schemes of drug pricing. Read More
Despite the FDA’s lingering concerns over study data, a 17-member advisory committee unanimously supported Perrigo’s bid to switch its progestin-only oral contraceptive Opill (norgestrel 0.075 mg) from prescription to OTC. Read More
Gilead Sciences has prevailed in what appears to be the first lawsuit filed by the U.S. government against a drugmaker in an attempt to enforce patent rights, dodging an almost $1 billion payout. Read More
Multiple unaddressed violations of current good manufacturing practice, FDA regulations and noncompliance with a 2012 consent decree have earned India’s Sun Pharmaceutical a hefty list of corrective actions to complete before resuming drug exports to the U.S. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
Device manufacturers that apply a more risk-based framework to corrective and preventive action (CAPA) plans rather than using the more typical one-size-fits-all approach could see reduction of up to 80 percent in the time required to implement improvements. Read More
The FDA has issued a final guidance to help manufacturers prevent the use of glycerin and other high-risk drug components contaminated with the toxic substances diethylene glycol (DEG) or ethylene glycol (EG), to combat a rise in fatal consumer poisonings. Read More