Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company’s ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg.
Bayer HealthCare announced today a structural realignment of its global pharmaceutical research and development organization. The company also outlined its future U.S. pharma site plan, and said that New Jersey will be home to its U.S. headquarters for pharmaceuticals. These moves follow Bayer?s acquisition of Schering AG, Germany in June 2006 and are part of the company?s plan to integrate its pharmaceutical operations with those of Schering AG and Berlex Inc. (the U.S. subsidiary of Schering AG).
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved pramipexole, a non-ergot dopamine agonist, for the treatment of moderate to severe primary Restless Legs Syndrome (RLS).1 This is an important milestone for pramipexole (Mirapexin? / Sifrol? / Mirapex?), which was already approved throughout the European Union in April 2006 for this second indication.
Bristol-Myers Squibb Company (NYSE: BMY) today announced that two-year data from three Phase III pivotal trials demonstrate the long-term efficacy of ORENCIA? (abatacept) in adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate and TNF antagonists. The data also demonstrate that ORENCIA provided clinically meaningful improvements in multiple aspects of health-related quality of life and physical function, sustained improvements in pain and had a consistent safety and tolerability profile through two years of treatment. These data will be presented at the upcoming 2006 American College of Rheumatology (ACR) Annual Scientific Meeting.
Experts believe the world is overdue for influenza pandemic. However, unless effective action against pandemic flu is taken now, we are in “dire straits,” according to a paper published in the November 10 issue of Science. The articled titled, “Next Flu Pandemic: What to Do Until the Vaccine Arrives?,” calls for research during the regular season flu season to better understand the effectiveness of non-pharmaceutical interventions such as social distancing, hand washing, face masks, and the like.
In Australia, there is a debate over the future roll-out of the new cervical cancer vaccine, Gardasil.
IDM Pharma (NASDAQ:IDMI) announced today that the company has submitted a Marketing Authorization Application (MAA) in eCTD format (electronic common technical document) to the European Medicines Agency (EMEA) for Mepact (mifamurtide for injection), requesting approval for its use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with post-operative multi-agent chemotherapy. This announcement follows the October 25, 2006 submission of a New Drug Application (NDA) for Junovan (mifamurtide for injection) to the Food and Drug Administration (FDA) in the United States.
Despite an overall decline in invasive breast cancer in the United States in recent years, African-American women, particularly younger ones, have not seen a significant decline in their rates, according to researchers at the University of Pittsburgh. These findings, which are being presented at the American Public Health Association (AHPA) Annual Meeting in Boston, Nov. 4 ? 8, strongly suggest the need for additional research to understand why these differences persist and to determine whether avoidable or preventable factors account for these puzzling patterns, according to the investigators.
Researchers have announced a breakthrough on a non-hormonal compound known as Adjudin. When injected as an attachment to a modified hormone that seeks out the testes, a low dose is a safe and effective contraceptive in rats. However, another promising drug, miglustat, has failed to make the leap from mice to men.
Researchers at the Jackson Laboratory, in collaboration with scientists at Bristol-Myers Squibb Oncology, discovered is that imatinib does not inactivate all BCR-ABL signaling pathways in the cascade. Proteins called SRC kinases are still activated by BCR-ABL in imatinib-treated mouse leukemic cells. Treatment with dasatinib, which inhibits the SRC proteins as well as BCR-ABL, was not only more effective for CML, but also led to complete B-ALL remission.