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Two phase III clinical trials evaluating the investigational use of once-daily tenofovir alafenamide (TAF, Gilead Sciences) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection have met their primary objectives. The…
Dräger is recalling the PS500 — an optional battery power supply sold for use with the Dräger Evita and Babylog ventilators — because a software issue causes shorter-than-expected battery run times, the FDA says. The Evita V500 ventilator provides constant breathing support for adults and children,…
The FDA has granted priority review to the new drug application (NDA) for an investigational once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi (Gilead Sciences) in December 2013, and velpatasvir (VEL), an investigational pan-genotypic…
Positive results have been reported from an open-label clinical study evaluating the pharmacodynamic activity of RDX022 (Ardelyx, Inc.) in healthy adult volunteers. The study demonstrated that RDX022, an investigational potassium binder for the treatment of hyperkalemia, effectively binds potassium…
The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal agent posaconazole (Noxafil, Merck) have resulted in dosing errors. To help prevent additional medication errors, the drug labels have been revised to indicate that the two oral formulations…
Positive data have been reported from subgroup analyses of a phase III pivotal trial comparing cabozantinib (Cometriq, Exelixis, Inc.) with everolimus (Afinitor, Novartis) in 658 patients with renal cell carcinoma (RCC) who have experienced disease progression after treatment with a vascular endothelial…
Positive results have been reported from a phase III study investigating the dopamine antagonist amisulpride (Baremsis, Acacia Pharma) in combination with standard antiemetics for the prevention of post-operative nausea and vomiting (PONV) in high-risk patients. The study compared the prophylactic use…
A new federal rule now requires prior authorization before Medicare will pay for certain wheelchairs, prosthetics, orthotics, and other medical equipment — sources of Medicare fraud and improper payments for years, according to a report in USA Today. The rule could save Medicare $10 million the first…
The FDA has issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices,…
Four biotech firms plan to announce important clinical trial findings in the first quarter of 2016, according to a report posted on the 24/7 Wall St. website. Zafgen Inc. is readying top-line results from a phase III study of beloranib in patients with Prader–Willi syndrome (PWS). The study’s objective…
Opponents of the 21st Century Cures Act, which is intended to accelerate the transfer of scientific advances in genetics into treatment for patients, say the legislation will threaten patient safety by easing FDA rules intended to protect patients from unproven therapies, according to a report in Medical…
BPN14770 (Tetra Discovery Partners), an investigational drug that may improve memory, is being tested in a phase I safety trial funded by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging, both part of the National Institutes of Health (NIH). The compound…
New Jersey’s nonprofit hospitals, which are traditionally exempt from paying taxes, would have to make payments to their host communities to cover the cost of municipal services under a new bill making its way through the state legislature, according to a report from BloombergBusiness. Lawmakers are…
Important research progress in 2015 offered new leads in stopping multiple sclerosis (MS), according to a report from the National MS Society. MS is a potentially disabling disease of the central nervous system in which the flow of information within the brain, and between the brain and the body, is…
The Etest PIP/TAZO/CON-4 PTC 256 has been recalled by bioMérieux because the test results from the affected product may indicate that antibiotic therapy using piperacillin/tazobactam (PIP/TAZO) could stop or slow the growth of certain bacteria when it may not actually be effective in treating those…

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