The developmental oral therapy FTY720 (fingolimod) has demonstrated sustained benefits over two years in patients suffering from relapsing multiple sclerosis (MS), indicating that it could provide an important new option for treating this disabling neurological disease estimated to affect more than 2.5 million people worldwide.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. today announced that ceftobiprole, a novel cephalosporin(1) antibiotic in Phase III clinical trials, was found to be active against complicated skin infections caused by common, potentially deadly bacteria, including MRSA. These data were from two poster presentations given at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). These data also were highlighted by ICAAC. Ceftobiprole is being co-developed with Basilea Pharmaceutica, Ltd. through an exclusive worldwide collaboration.
UAB (University of Alabama at Birmingham) researchers are investigating whether a common but usually harmless virus can be used to treat a particularly devastating type of brain tumor called malignant glioma. The virus — respiratory enteric orphan virus, or reovirus — inhabits the lungs and intestines of humans. By adulthood, most humans have been exposed to it but demonstrate no illness or effects from the infection.
Pfizer Inc said today that the European Commission has approved Champix(R) (varenicline), a novel pill for smoking cessation in adults. In addition, because smokers often need considerable support to quit successfully, Champix will be available with a patient support plan which smokers can customize to address their individual behavioral triggers as they try to quit smoking.
Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has approved, after a Priority Review, two additional uses for Rituxan(R) (Rituximab) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). One new indication for Rituxan is for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Johnson & Johnson Pharmaceutical Research & Development (JJPRD), L.L.C. announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for paliperidone extended-release (ER) tablets for the treatment of schizophrenia.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the results of a Phase 1 clinical trial of HGS004 (CCR5 mAb) demonstrate that it was well tolerated and exhibited antiviral activity in patients who are infected with HIV-1, the retrovirus that causes acquired immunodeficiency syndrome (AIDS). The results were reported in San Francisco in an oral presentation at the American Society for Microbiology’s 46th Annual Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Transfer of a gene that produces a mutant form of good cholesterol provides significantly better anti-plaque and anti-inflammation benefits than therapy using the “normal” HDL gene, according to a mouse study conducted by cardiology researchers at Cedars-Sinai Medical Center and reported in the Oct. 3 issue of the Journal of the American College of Cardiology.
Contrary to oral warfarin therapy, the use of subcutaneous low-molecular weight heparin (LMWH) has the advantage of stable dosing without the need of prothrombin time monitoring. Few randomized studies have compared the efficacy of LMWH with the least costly unfractionated heparin for the treatment of deep vein thrombosis (DVT). In the United States, 6 days of LMWH therapy for an 80 kg patient is estimated to cost $712, compared with $37 of unfractionated heparin.
The potent cancer drug Gleevec, used to combat leukemia and some gastrointestinal cancers, may be useful in treating rheumatoid arthritis, according to a team of researchers at the Stanford University School of Medicine. Their findings will be published in the October issue of the Journal of Clinical Investigation.