Boehringer Ingelheim Pharmaceuticals GmbH., of Ingelheim, Germany, said the FDA granted priority review to the biologics license application for idarucizumab, which is being investigated to specifically reverse the anticoagulant effect of dabigatran, the active ingredient in Boehringer's Pradaxa in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event. Read More
Insys Therapeutics Inc., of Phoenix, said it started dosing pediatric epilepsy patients in a phase I/II safety and pharmacokinetic (PK) study in subjects with treatment-resistant seizures. Read More
Cytori Therapeutics Inc., of San Diego, said data from two preclinical studies funded through its contract with the U.S. Biomedical Advanced Research and Development Authority were presented at the American Burn Association meeting in Chicago. Read More
Alexion Pharmaceuticals Inc., of Cheshire, Conn., reported first quarter earnings, tallying net product sales of Soliris (eculizumab) of $600.3 million, compared to $566.6 million for the same period in 2014, which included reimbursement of $87.8 million from shipments in prior years related to an agreement with the French government. Read More
BOSTON – Gone are the days of expensive diagnostics and lengthy clinical trials, as interest and enthusiasm over digital medicine and personalized medicine are shifting the attitudes and expectations of drug developers and insurance companies, as well as consumers themselves. Read More
As with any new technology, it takes baby steps to get drugs through the regulatory process and onto the market. And nanomedince is no exception. The technology is certainly progressing, but at a methodical pace. Read More
LONDON – Researchers have used genome editing to selectively eliminate mitochondria mutations in the germline of mice, a technique they suggest could be applied to the treatment of mitochondrial diseases in humans. Read More
WASHINGTON – The FDA has been under the gun to qualify more biomarkers that could help accelerate the development of targeted therapies and track the progression of various diseases. Read More
Fluorine-focused Scifluor Life Sciences Inc. pulled down $30 million that should "allow us to get into what we suspect will be four phase I trials" with a pair of compounds – including eye drops for age-related macular degeneration (AMD) – and provides "at least a two-year runway," CEO Omar Amirana told BioWorld Today. Read More
Merck & Co. Inc., of Kenilworth, N.J., disclosed data from C-SURFER, the company's phase II/III trial testing a once-daily treatment regimen of grazoprevir (100 mg) and elbasvir (50 mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1. Read More
