Irish drugmaker Shire Plc. said the U.S. Food and Drug Administration approved the use of attention-deficit/hyperactivity disorder treatment Intuniv with a stimulant in the treatment of children and adolescents aged 6 to 17 years.
Santarus Inc. said the Food and Drug Administration did not accept a marketing application for its drug Rhucin, which is designed to treat a genetic disorder that can cause dangerous swelling of the throat and extremities.
Mylan Inc. said its Matrix Laboratories unit received Food and Drug Administration approval to market a generic version of Pfizer Inc.'s drug Neurontin. Neurontin was originally approved as a treatment for seizures and more recently cleared for pain caused by shingles.
Pfizer Inc. said it received European Commission approval for the Dupuytren's contracture treatment Xiapex. Dupuytren's contracture is a condition that makes the tendons of the hand thicken and shorten, causing the fingers to curve inward.
Forest Laboratories Inc. and Switzerland's Nycomed said the Food and Drug Administration approved the drug Daliresp to reduce symptoms associated with a severe lung disease, despite a negative recommendation from experts last year.
Approximately 23.6 million people in the United States have diabetes; of these, 5% to 10% have type 1a diabetes mellitus (T1DM). T1DM is an autoimmune disease in which abnormal immune responses destroy insulin-producing pancreatic beta cells.
Affymetrix, Inc. launched the GeneChip miRNA 2.0 Array. This enhanced version of its microRNA interrogation solution will support personalized medicine by accelerating the identification of biomarkers and gene expression signatures associated with disease.
Thermo Fisher Scientific Inc. introduced its ID Scribe Labware Identifier for the consistent and legible labeling of storage tubes, vials and other common labware.
Elan, plc and PPD, Inc. announced they have formed a global business collaboration focused on the advancement, progression and execution of Elan's development portfolio.
Packaging, storage and distribution of schedule I – V controlled substance is now a fully functional capability of Almac’s new North American Headquarters facility in Souderton PA.
For the first time, pluripotent stem cells have been generated from horses. Because horses' muscle and tendon systems are similar to our own, this may aid the development of preclinical models leading to human applications.
In Europe and the USA, 10% of treatment-naïve patients are infected with transmitted drug resistant (TDR) HIV that already has at least one drug-resistant mutation. These patients are more than three times as likely to experience treatment failure.
Nile Therapeutics, Inc., a company focused on the development of novel therapeutics for heart failure patients, announced plans to collaborate with Medtronic, Inc. on the clinical development of Nile’s proprietary natriuretic peptide, cenderitide, for heart failure and renal disease applications.
Shire plc submitted a complete response to the not approvable letter issued by the US Food and Drug Administration to Jerini AG in April 2008 regarding its New Drug Application for FIRAZYR for the treatment of acute attacks of hereditary angioedema.
Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates. Much of this horrific history is 40 to 80 years old, but it is the backdrop for a meeting in Washington this week by a presidential bioethics commission.