Last Frontier in Patient Monitoring Now Conquered: Noninvasive and Continuous Temperature Monitoring Has Arrived. Brain Tunnelgenix Technologies Corp. announced today that the U.S. Food and Drug Administration has granted the company clearance to market its Abreu BTT 700 System for continuous temperature monitoring.
ALISO VIEJO, Calif., Sept. 9 Clarient, Inc., a premier anatomic pathology and molecular testing services resource for pathologists, oncologists and the biopharmaceutical industry, today announced that the Company's presentation time at the Baird 2010 Health Care Conference has changed to 9:00 am EDT on Tuesday, September 14, 2010.
FDA NEWS RELEASE. FDA approves pediatric use of chemical poisoning treatment. The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride, a drug used to treat poisoning by organophosphate pesticides and chemicals.
NEW YORK Santarus Inc. said Wednesday it bought the rights to make and sell a new type 2 diabetes drug from two other drugmakers, and its shares surged in Thursday trading.
CAMBRIDGE, Massachusetts, September 9, 2010 Shire plc, the global specialty biopharmaceutical company, today announced the expansion of its Human Genetic Therapies pipeline through the exclusive license, in markets outside of North America, for the activin receptor type IIB class of molecules being developed by Acceleron Pharma Inc., a private biot
Tornier, Inc., a global leader in extremity and sports medicine orthopaedics, announced today the successful early clinical results of the first seven pyrocarbon shoulder prostheses that were implanted between April 2009 and December 2009.
Alexion Pharmaceuticals, Inc. announced that the US Food and Drug Administration has approved Alexion's Rhode Island manufacturing facility in Smithfield, Rhode Island as a second source of commercial supply for Soliris. Earlier this year, Alexion reported that the European Medicines Agency had approved ARIMF as a second source of supply for Soli
CytRx, a biopharmaceutical company, has initiated the Proact Phase II proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer. The open-label Proact trial is being conducted at City of Hope, California, as well as multiple clinical sites in India.
Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced that it received CE Mark approval to market its expanded offering of Powerlink stent graft products and PowerFit Aortic Extensions in the European Union.
- New Position to Support Global Customer Strategy and Accelerate Growth - BioClinica, Inc., a global provider of clinical trial management services, today announced the appointment of Garry D. Johnson as Senior Vice President and Chief Technology Officer, a newly created position.
Neuralstem, Inc. announced that it has filed an Investigational New Drug application with the United States Food and Drug Administration to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells.
ALLEGAN, Mich., Sept. 8 Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.
ALLEGAN, Mich. Aldara, made by Graceway Pharmaceuticals, is also used for superficial basal cell carcinoma and external genital and perianal warts in patients 12 years old or older. In addition to making pharmaceutical products, Perrigo, which is based in Allegan, Mich., makes infant formulas, nutritional products and pharmaceutical and medical dia
Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, will present at the Rodman & Renshaw 12th Annual Healthcare Conference in New York City on September 14, 2010 at 3:15 p.m. Eastern Time. Tim Scott, President of Provectus will be delivering the presentation.
UNION CITY, Calif., Sept. 8 Questcor Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has informed Questcor that the FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application for H.P. Acthar Gel in the treatment of in
PresbyLens Renamed Vue+ ReVision Optics, a leading company in the research, development and manufacture of implantable medical devices designed to assist patients that need reading glasses, announced today that it has completed enrollment and initial follow up in Phase I of its US clinical trial and has filed for expansion. The Vue+ study will eval
Use of an experimental targeted drug to treat metastatic melanoma tumors with a specific genetic signature was successful in more than 80 percent of patients in a phase 1 clinical trial.
Pharmaceutical company Watson Pharmaceuticals Inc reported on Tuesday that its subsidiary, Watson Laboratories Inc, has received US approval for its generic equivalent to BayerEURs Yasmin oral contraceptive tablet. The US Food and Drug Administration has approved WatsonEURs Abbreviated New Drug Application for Zarah 3 mg/0.03 mg and the company
ALISO VIEJO, Calif., Sept. 7 Clarient, Inc., a premier anatomic pathology and molecular testing services resource for pathologists, oncologists and the biopharmaceutical industry, today announced that the Company is scheduled to make investor presentations at two investor conferences in the month of September.
09/07/10 Daxor Corporation, a medical instrumentation and biotechnology company, today announced the receipt of a signed trial agreement from the Baltimore VA Medical Center of Baltimore, Maryland. The Baltimore VA Medical Center is one of the most modern health care facilities in the country, offering veterans state-of-the-art medical technolog
Forest Laboratories, Inc. announced that the U.S. Food and Drug Administration's Anti-Infective Drugs Advisory Committee voted 21 - 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia and voted 18 - 0 in favor of approval for complicated skin and skin structure infections.
The Food and Drug Administration, Center for Biologics Evaluation and Research is announcing a public workshop entitled "Cell and Gene Therapy Clinical Trials in Pediatric Populations."
Intellect Neurosciences, Inc., a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has engaged Dr. Giora Feuerstein as a key consultant to advise the Company regarding its technology programs and pipel
CAMBRIDGE, Mass., Sept. 7 Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration that the IDX184 and IDX320 programs have been
