Ipsen SA, of Paris, reported phase IIa results showing that Dysport was associated with a mean reduction from baseline of urinary incontinence episodes greater than 75 percent, 12 weeks after injection, regardless of how the drug was administered in patients with urinary incontinence not adequately managed by anticholinergics. Read More
Alcobra Ltd., of Tel Aviv, Israel, said the first patient has been enrolled in a phase III trial of metadoxine extended release (MDX) in the treatment of adults with attention deficit hyperactivity disorder (ADHD). Read More
Bioatla LLC, of San Diego, and Telephus Medical LLC, also of San Diego, which develops vaccine products to prevent periprosthetic joint infections, said Bioatla completed a protein engineering phase of Telephus’ compound, TPH 101, which is focused on the development of neutralizing antibodies targeting a key bacterial enzyme that drives the formation of antibiotic-resistant biofilm infections on implanted medical devices. Read More
Dipexium Pharmaceuticals Inc., of New York, said it closed its initial public offering of about 3.2 million shares priced at $12 apiece, including 412,500 shares to cover overallotments. Gross proceeds totaled about $38 million. Read More
As part of its revision of a March 2003 guidance on bioavailability (BA) and bioequivalence (BE) studies for orally administered drugs, the FDA released a draft guidance on conducting BA and BE studies for investigational new drugs, new drug applications (NDAs) and NDA supplements. Read More
No matter what the cause – cluster headaches, migraines, cancer, nerve damage, temporomandibular joint disorder, trigeminal neuralgia or another disorder – chronic head pain remains among the most vexing of medical conditions for patients and the most daunting of challenges for scientists. Over-the-counter remedies that may help acute conditions often are ineffective for chronic pain, and opioids that can relieve pain come with serious downsides. Read More
HONG KONG – A biological extract that targets two proinflammatory protein pathways is showing promise against pancreatic cancer and may have potential for the management of several other malignancies, researchers said. Read More
Biosimilar makers have their work cut out for them if they hope to increase the use of their follow-on biologics in Europe. Much of that work is in helping doctors over the learning curve. Read More
Medivation Inc. and partner Astellas Pharma Inc. made the latest move in the battle for prostate cancer marketing share by submitting a supplemental new drug application (sNDA) seeking a label for Xtandi (enzalutamide) in chemotherapy-naïve men. Read More
