The FDA has cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology (Johnson & Johnson Vision Care, Inc.) are soft contact lenses indicated for daily use…
The FDA has approved rucaparib (Rubraca, Clovis Oncology, Inc.) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The agency granted regular approval…
The FDA has issued an order to restrict the sale and distribution of the Essure permanent contraception device (Bayer) to ensure that all women considering use of the device are provided with adequate risk information so that they can make informed decisions. The agency is taking this step after becoming…
Alzheimer’s researchers have proposed a radical change in the way the disease is defined, focusing on biological changes in the body rather than clinical symptoms such as memory loss and cognitive decline, according to a Reuters report. The new research framework, released by the Alzheimer’s Association…
Positive first-time results have been published for Duobrii (halobetasol propionate and tazarotene lotion, Ortho Dermatologics) for the treatment of plaque psoriasis. The data appear in the Journal of the American Academy of Dermatology. Two phase 3, multicenter, randomized, double-blind clinical trials…
The pivotal, phase 3 KEYNOTE-042 trial evaluating pembrolizumab (Keytruda), Merck’s anti-programmed death-1 (PD-1) therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non–small-cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary…
The FDA has permitted marketing of the Dexcom G6 (Dexcom, Inc.) integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in patients two years of age and older with diabetes. This is the first type of continuous glucose monitoring system permitted by the agency to…
The FDA has granted accelerated approval to blinatumomab (Blincyto, Amgen) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen…
Rising drug prices have gotten a lot of attention lately, but the actual cost of prescription medications is more than just the dollars and cents on the bill, according to a recent study. Researchers at the University of California San Diego (UCSD) estimate that illness and death resulting from nonoptimized…
The Justice Department is seeking court permission to participate in settlement negotiations aimed at resolving lawsuits by state and local governments against opioid manufacturers and distributors, according to a Reuters report. The Justice Department said in a brief that it wanted to participate in…
The Centers for Medicare and Medicaid Services (CMS) has laid out a bevy of initiatives that officials said would reduce drug prices for patients covered by the Medicare Part D prescription drug program—but they have made no decisions yet on an issue that has confounded lawmakers and patients alike,…
Seven public health and medical groups have filed a lawsuit challenging an FDA decision that they said would allow e-cigarettes to remain on the market for years without regulatory review, Reuters reports. The lawsuit, filed in federal court in Greenbelt, Maryland, argued the FDA in August improperly…
Despite the threat of a global health crisis in antibiotic resistance, worldwide use of antibiotics in humans soared 39% between 2000 and 2015, fueled by dramatic increases in low-income and middle-income countries (LMICs), according to a new study in the Proceedings of the National Academy of Sciences…
The FDA has approved Toujeo (insulin glargine 300 units/mL, Sanofi) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the market. The new pen holds 900 units of Toujeo, more than any other long-acting insulin pen in the U.S., and provides up to 160 units/mL of Toujeo…
Aetna, Inc., has announced that it will automatically pass on drug-maker rebates to about three million commercial members at the point of sale beginning in 2019, according to a BioPharma Dive report. The move comes less than a month after UnitedHealth Group, Inc., announced a similar initiative, which…
