• Almirall SA, of Barcelona, Spain, said the European Commission granted marketing approval to Eklira/Bretaris Genuair (aclidinium 322 mcg twice daily) in European Union member states, plus Iceland and Norway, for chronic obstructive pulmonary disease. It will be used as a maintenance bronchodilator treatment to relieve symptoms of the disease. Read More
• Bio-Path Holdings Inc., of Houston, said it started enrolling patients in the fourth dosage cohort for its Phase I trial of lead candidate BP-100.1.01 (liposomal Grb-1), which is being evaluated as a systemic treatment for blood cancers, including acute myeloid leukemia, chronic myelogenous leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome. Read More
• Ligand Pharmaceuticals Inc., of San Diego, reported that the FDA granted priority review to its partner GlaxoSmithKline plc, of London, for the supplemental new drug application for Promacta (eltrombopag) to treat thrombocytopenia in adult patients with chronic hepatitis C. Promacta, marketed as Revolade outside the U.S., is approved in 89 countries to treat chronic immune thrombocytopenia. Read More
• Oxford BioMedica plc, of Oxford, UK, disclosed details of a proposed share issue to raise gross proceeds of £16 million (US$24.8 million) – £14.5 million net of expenses – by way of placing 440 million new ordinary shares priced at 1 pence apiece and an open offer of up to 201 million shares priced at 2.5 apiece. Read More
The FDA could be facing a quandary brought on by the growing epidemic of prescription drug abuse as it tries to balance the need for tamper-resistant painkillers with the demand for access to cheaper generics. Read More
WASHINGTON – As researchers continue to look for treatments and cures, one place where they are looking is in those rare patients who are naturally able to deal with HIV. Those patients fall into several groups. Read More
A strong launch of Eylea (aflibercept injection) for age-related macular degeneration led Regeneron Pharmaceuticals Inc.'s revenues for the second quarter, with $194 million in sales. Read More
• Sanofi Pasteur, the vaccines division of Paris-based Sanofi SA, said its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, generating antibody response for all four dengue virus serotypes. Read More