Category: Food and Drug Administration

FDA puts Seattle Genetics drug trials on hold after 4 deaths

Seattle Genetics Inc said four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage studies. Six patients with acute myeloid leukemia , a type of blood cancer, have been identified with liver toxicity and four have died, the company said on Tuesday.

FDA grants permission to assess safety of investigational drug for Alzheimer’s disease in humans

Vanderbilt University scientists have received notification from the U.S. Food and Drug Administration that testing in humans may proceed for an investigational new drug for Alzheimer’s disease after more than 10 years of research by scientists at Vanderbilt University and Vanderbilt University Medical Center. It is relatively uncharted territory for an academic drug discovery group to take a molecule from the laboratory setting to the clinical trials stage.

Portola Pharmaceuticals Announces FDA Accepts New Drug Application…

Portola Pharmaceuticals, Inc.A today announced that the U.S. Food and Drug Administration accepted Portola’s New Drug Application granting priority review for betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous thromboembolism in acute medically ill patients with risk factors for VTE. A priority review shortens the FDA review timeline to six months from the standard review period of 10 months.

Legal Haze Clouds Cannabis For Pets

… client’s written consent is needed for any unorthodox treatment,” the memo stated. The Washington State Department of Health staffs the state’s Veterinary Board of Governors. The Department’s home page for veterinarians simply states, “The law …

Swiss stocks – Factors to watch on Dec 21

The U.S. Food and Drug Administration has extended until March 28 the date for reviewing the application for multiple sclerosis drug Ocrevus. “The extension is the result of the submission of additional data by Roche regarding the commercial manufacturing process of Ocrevus, which required additional time for FDA review.

Tetraphase Pharmaceuticals Provides Regulatory and Clinical Update for Eravacycline

Tetraphase Pharmaceuticals, Inc. , a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant infections, today provided a regulatory and clinical development update for eravacycline, the Company’s lead antibiotic candidate with potent activity against MDR pathogens, which is being developed for the treatment of serious and life-threatening bacterial infections. During the second half of 2017, Tetraphase plans to submit a Marketing Authorization Application to the European Medicines Agency for IV eravacycline for the treatment of cIAI.

SK Chemicals’ hemophilia drug approved in Canada

SK Chemicals, the biopharmaceuticals unit of South Korea’s SK Group, has obtained regulatory approval to sell its hemophilia treatment in Canada, marking another step forward in breaking into overseas markets. SK Chemicals said Sunday that Health Canada, the country’s drug regulator, has granted marketing and sales approval for Afstyla, a biologic drug for hemophilia developed by SK Chemicals and licensed out to Australian biotech firm CSL Ltd. in 2009.