ADA: Glucose Monitors Lack Uniformity

ORLANDO (MedPage Today) — The accuracy of glucose monitoring devices used by patients and physicians alike leaves a lot to be desired, as this exclusive InFocus report explains.

Nasal Sprays Recalled Over Quality Concern

The maker of a nasal decongestant spray product has issued a voluntary recall due to self-imposed quality control precautions.

New CMS Rules Focus on Primary Care, Target Radiology Cuts

WASHINGTON (MedPage Today) — Physicians would receive new payments for annual physicals under a proposed rule on 2011 Medicare payments to doctors released by the Centers for Medicare and Medicaid Service (CMS).

Nasal Sprays Recalled Over Quality Concern

The maker of a nasal decongestant spray product has issued a voluntary recall due to self-imposed quality control precautions.

Threshold Pharmaceuticals commences TH-302 Phase 1 clinical trial in patients with advanced leukemias

Threshold Pharmaceuticals, Inc., today announced that it has initiated a Phase 1 clinical trial of TH-302 in patients with advanced leukemias. TH-302 is a proprietary Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia.

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

Alimera submits Iluvien NDA for DME to FDA

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of [...]

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson’s disease.

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer.

Vitae earns $14M milestone payment from Boehringer Ingelheim

Vitae Pharmaceuticals, Inc., an integrated discovery and development company, today announced that it has earned a $14 million clinical milestone payment from Boehringer Ingelheim, one of the world’s 20 leading pharmaceutical companies. Vitae’s 11beta-hydroxysteroid dehydrogenase (HSD)-1 is targeted for the treatment of diabetes and metabolic syndrome-related diseases in a strategic alliance with Boehringer Ingelheim. The [...]