GOP Pledge Includes Vow to Repeal Reform Law

WASHINGTON (MedPage Today) — The “Pledge to America” unveiled by congressional Republicans on Thursday includes a vow to “repeal and replace” the healthcare reform law signed six months ago by President Obama.

Rosiglitazone Stays, but Only for Some

(MedPage Today) — The controversial diabetes drug rosiglitazone (Avandia) can remain on the market, but new patients can receive it only if their blood sugar can’t be controlled with pioglitazone (Actos), the FDA announced today.

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, [...]

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Enobia Pharma today announced positive results for its Phase II juvenile clinical trial of ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy intended for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages.

Results of Argos’ Arcelis Phase 2 study for RCC accepted for presentation at International Kidney Cancer Symposium

Argos Therapeutics today announced that results from its Arcelis™ immunotherapy Phase 2 study for the treatment of renal cell carcinoma (RCC) have been accepted for a poster presentation at the Ninth International Kidney Cancer Symposium on Oct. 1-2 in Chicago.

Yaupon reports positive results from mechlorethamine gel study for early-stage cutaneous T-cell lymphoma

Yaupon Therapeutics, a privately held specialty pharmaceutical company, today announced positive top-line results from the pivotal multi-center study of its lead product candidate, a proprietary topical mechlorethamine gel for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages I-IIa). The top-line data show that the study, which was conducted under a Special Protocol Assessment [...]

Cylene commences CX-4945 Phase I trial in multiple myeloma

Cylene Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of their first-in-class, oral CK2 inhibitor CX-4945 in patients with multiple myeloma. Cylene also announced the simultaneous closing of a $12 million financing with participation from existing investors including Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, [...]

Phase 3 clinical study demonstrates efficacy of metformin therapy in type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone.

Biothera receives SBIR award to evaluate therapeutic potential of Imprime PGG drug in pancreatic cancer

Biothera has received a National Cancer Institute SBIR award to evaluate the therapeutic potential of its drug candidate Imprime PGG in pancreatic cancer, the company announced today.

GSK Regulatory Update On Avandia Following EMA And FDA Reviews

GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has announced their individual regulatory decisions and the resulting actions…