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,…
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…
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…
Prices for each of the 20 most-prescribed brand-name drugs for seniors have increased dramatically every year for the past five years, according to a new report released by U.S. Senator Claire McCaskill (D- Missouri). The cost of the drugs, which include brands like Advair (fluticasone propionate and…
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…
Sun Pharma’s $80 million psoriasis licensing deal with Merck & Co. just paid off with an FDA approval, according to a FiercePharma report. But now, another challenge begins: The new med will go up against established psoriasis player Johnson & Johnson. The FDA has officially green-lighted the Indian…
The FDA has approved the ranibizumab injection (Lucentis, Genentech) 0.3-mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy. In April 2017, Lucentis 0.3 mg became, and remains, the first and only FDA-approved medicine to treat all forms…
The second time proved to be the charm for the U.S. House of Representatives to pass right-to-try legislation that would provide terminally ill patients access to experimental drugs without the approval of the FDA, according to a BioSpace article. The House approved a second bill with a 267–149 vote…
The FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) in combination with chemotherapy in adult patients with previously untreated stage III or IV classical Hodgkin’s lymphoma. The approval is based on the successful outcome of the phase 3 ECHELON-1 clinical trial that compared…
The FDA has expanded the indication for nilotinib (Tasigna, Novartis) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). In the United States, nilotinib is now indicated…
Roche’s immunotherapy atezolizumab (Tecentriq) has racked up a third trial win in combination with other cancer drugs, a boost for the Swiss drug-maker as it seeks to muscle in on space dominated by Merck and Bristol-Myers Squibb, according to a Reuters report. A late-stage study, called IMpower131,…
