Cumberland Pharmaceuticals Inc. announced the U.S. Food and Drug Administration has extended its review of the supplemental new drug application for the use of Acetadote Injection in patients with non-acetaminophen acute liver failure.
EndoGastric Solutions, the recognized leader in the emerging field of Natural Orifice Surgery, announced that Floyd D. Loop, M.D., has joined its Board of Directors. "Dr. Loop is the ideal individual to join our Board of Directors at this stage in the company's evolution," said Thierry Thaure, President and Chief Executive Officer of EndoGastric So
New research, 'Contrast-induced nephropathy in patients undergoing computed tomography - a clinical problem in daily practice? "Each department used center-specific CT protocols.
ThromboGenics, a Belgian biopharmaceutical company, has reported positive pooled results from the successful microplasmin Mivi-Trust Phase III program, confirming microplasmin's potential to transform the treatment of retinal disorders.
Ascension Orthopedics, a developer of PyroCarbon orthopedic devices, has received FDA approval to market the Titan modular total shoulder system. According to the company, the Titan modular total shoulder system offers a bone-preserving option for patients needing total or hemi shoulder arthroplasty.
Sept. 05Can-Fite BioPharma Ltd. has obtained US Food and Drug Administration approval for the Phase III clinical trial of its CF101 anti-inflammatory drug for the treatment of dry-eye syndrome. Can-Fite added, however, that to register the drug for use, two Phase III trials, with 500 patients altogether, will be needed.
- Neurological and infectious disease experts at Rush University Medical Center are testing a new drug therapy for the treatment of individuals with West Nile fever or suspected central nervous system infection due to the West Nile virus.
CSL Behring announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 18 months to 24 months. Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature for up to 24
American International Biotechnology Services, a division of Bostwick Laboratories, Richmond, VA, announced that it is one of four contractors awarded a new government contract valued at approximately $21 million. "This new contract marks a significant milestone for our company," explained Dr Robert B. Harris, President and CSO, AIBioTech, and Prog
Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration.
Current study results from the report, 'Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial,' have been published. "From January 2007 to August 2009, 136 patients underwent catheterization for intended Melody valve implantation at 5 centers.
SUMMARY: The Food and Drug Administration is publishing a list of premarket approval applications that have been approved. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm.
GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta belimumab as a potential treatment for systemic lupus erythematosus.
Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for BENLYSTA belimumab as a Potential Treatment for Systemic Lupus Erythematosus. Human Genome Sciences, Inc. and GlaxoSmithKline PLC announced that the U.S. Food and Drug Administration has granted a priority review designation to BENLYSTA as a potential treatme
www.OTCtipReporter.com Reports Critical NEWS ALERTS Green Globe International, Inc., Orexigen Therapeutics, Inc., Cardiome Pharma Corp., Car Charging Group, Inc. Sign-Up for our FREE Stock Alerts AND AWARD WINNING NEWSLETTER at HYPERLINK "http://www.OTCtipReporter.com/" www.OTCtipReporter.com -
www.OTCtipReporter.com Reports Critical NEWS ALERTS Green Globe International, Inc., Orexigen Therapeutics, Inc., Cardiome Pharma Corp., Car Charging Group, Inc. Sign-Up for our FREE Stock Alerts AND AWARD WINNING NEWSLETTER at HYPERLINK "http://www.OTCtipReporter.com/" www.OTCtipReporter.com -
Actavis, a US-based manufacturing and marketing unit of generics firm Actavis Group, has received approval from the US Food and Drug Administration, or FDA, to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder, or ADHD. Actavis intends to market Atomoxetine HCl in 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 10
Agensys, an affiliate of Tokyo-based Astellas Pharma, a pharmaceutical company, has initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate, or ADC, that is being developed for the treatment of metastatic renal cancer.
AUSTIN, Texas, Sept. 2 Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic devices, announces FDA approval to market the TITAN Modular Total Shoulder System.
CARY, N.C., Sept. 2 Cetero Research, the leading early-stage contract research organization, is launching a series of scientific seminars, "An Accelerated Path to Proof-of-Concept in Drug Development," designed to help pharmaceutical and biotechnology researchers learn the latest innovations in Phase I and IIa clinical trial designs.
09/02/10 Daxor Corporation, a medical instrumentation and biotechnology company, today announced that the Board of Directors has voted to declare a dividend of $0.25 per share. This is the second dividend the Company has declared for 2010. These payments are in keeping with the declaration of Company management in 2008 to pay dividends when fund
ThromboGenics, a biopharmaceutical company, has announced that it's second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion, or VMA, has met its primary endpoint. The trial also confirmed the positive results seen in the first Phase III trial with microplasmin.
FDA panel recommends approval of new emergency contraceptive pill. Ulipristal acetate pill already available in 22 European countries. American women might have another option in emergency contraception if the Food and Drug Administration follows the recommendation of its reproductive health panel in approving ulipristal acetate.
