Pharma News

AstraZeneca, a global, innovation-driven biopharmaceutical business,  announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma.

Sandoz, a global leader in generic pharmaceuticals and a  subsidiary of Novartis, has received approval from the US Food and Drug Administration (FDA) for Glatopa. Glatopa is the first FDA-approved, substitutable generic version of Copaxone^® 20mg, a treatment for relapsing forms of multiple sclerosis. Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy.

Bacteria can use tiny magnetic particles to effectively create a 'natural battery', a new study has found. The bacteria can load electrons onto and discharge electrons from microscopic particles of magnetite, researchers said. This discovery holds out the potential of using this mechanism to help clean up environmental pollution, and other bioengineering applications, they said.

A team of three engineering students from Rice University, Houston, United States, created the device to ease the pain of an injection. A new drug injector called "Comfortably Numb" is a cooling device. It numbs the skin prior to getting a shot.  It works like an ice pack, which produces a rapid chemical reaction that cools and numbs patients' skin in seconds. The device consists of a small 3D-printed cylinder with a metal plate at one end. It contain ammonium nitrate and water in separate compartments.

Aeterna Zentaris Inc., a specialty biopharmaceutical company, is planning to conduct a new, confirmatory phase 3 clinical study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (AGHD), as well as a dedicated thorough QT study to evaluate the effect of Macrilen on myocardial repolarisation.

Sagent Pharmaceuticals, Inc., a specialty pharmaceutical company has launched Vancomycin hydrochloride for injection, USP, an anti-infective, in a 10 gram preservative-free pharmacy bulk package presentation.

The US Food & Drug Administration (FDA) has granted Fast Track designation to Exelixis, Inc's cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC). Cabozantinib is the Exelixis' lead compound . Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer.

Dr. Reddy's Laboratories and its subsidiary, Promius Pharma™, LLC announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the U.S. Food and Drug Administration (US FDA).