ADELPHI, Md. (MedPage Today) — An FDA advisory panel has voted overwhelmingly to recommend approval of AstraZeneca’s investigational antiplatelet drug ticagrelor (Brilinta), saying it appears more effective than clopidogrel (Plavix) for patients with acute coronary syndrome who will be treated either medically or with PCI.
Filed under: General Health News
(MedPage Today) — The manufacturers of a softgel supplement marketed as an eye vitamin issued a voluntary recall of the product due to a potential choking hazard.
Filed under: General Health News
(MedPage Today) — An FDA advisory panel will revisit an increasingly familiar battleground this week, as it considers whether a drug sponsor can substitute a surrogate endpoint for a clinical outcome in a pediatric pulmonary arterial hypertension (PAH) trial.
Filed under: General Health News
(MedPage Today) — The East Coast’s largest drugstore chain, Rite Aid, settled a Health Insurance Portability and Accountability Act (HIPAA) privacy violation case with the Department of Health and Human Services (HHS) for $1 million.
Filed under: General Health News
(MedPage Today) — The manufacturers of a softgel supplement marketed as an eye vitamin issued a voluntary recall of the product due to a potential choking hazard.
Filed under: Pharmacy News
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel was split over whether to recommend approval for an investigational Medtronic spine device called Amplify — citing lack of data to prove the device’s benefits outweigh its risks for degenerative disc disease patients.
Filed under: Pharmacy News
Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for chronic fibrotic and metabolic diseases, today announced the signing of a cooperative research and development agreement (CRADA) with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health to conduct a double blind, multi-center, study to evaluate the effects of obeticholic acid in patients with nonalcoholic steatohepatitis (NASH).
Filed under: Pharmacy News
ArQule, Inc. today announced the initiation of a Phase 2, single agent trial with ARQ 197 in gastric cancer by Kyowa Hakko Kirin, its exclusive licensee for the development and commercialization of ARQ 197 in the Asian territory consisting of Japan, China (including Hong Kong), South Korea and Taiwan. Initiation of this trial will trigger a $5 million milestone payment to ArQule from Kyowa Hakko Kirin.
Filed under: Pharmacy News
Allos Therapeutics, Inc. today announced topline results from the Company’s randomized Phase 2b investigational trial of FOLOTYN® (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) who had received one or two prior systemic treatments including at least one prior platinum-based regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival.
Filed under: Pharmacy News
Allos Therapeutics, Inc. today reported its financial results and business highlights for the quarter and six months ended June 30, 2010.
Filed under: Pharmacy News
