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| Headline News | Thursday, January 8, 2004 | | Category | | Pharmaceutical Companies |
| |  | Amylin Pharmaceuticals Withdraws Swiss Regulatory Application for SYMLIN(R) | | | SAN DIEGO, Jan. 7 -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced receipt of correspondence from the Swiss Agency for Therapeutic Products (Swissmedic) indicating that SYMLIN(R) could not be approved for marketing in Switzerland based on data received to date. Full Details |
| |  | Elan achieves primary endpoint in Prialt Phase III trial | | | DUBLIN, IRELAND, JANUARY 7, 2004 --Elan Corporation, plc today announced that its recent Phase III trial for Prialt™ (ziconotide) met its primary endpoint in patients with severe chronic pain who had not achieved pain relief with other therapies including intrathecally delivered morphine. Full Details |
| |  | Namenda (Memantine HCl) Mild to Moderate Alzheimer's Disease Studies Reported Today Forest Laboratories to Seek Approval for Mild to Moderate Indication By Mid-Year | | | NEW YORK, Jan. 7, 2004 -- Forest Laboratories, Inc. announced that results of a U.S., Phase III study of Namenda (memantine HCl) as monotherapy in mild to moderate Alzheimer's disease show the drug demonstrated a statistically significant difference versus placebo with respect to the study's primary efficacy measures of cognition and global outcome. Results from a similar study conducted by H. Lundbeck in Europe showed significance at some interim time points, but not at the study's conclusion. Forest plans to seek approval for a mild to moderate indication based on the positive outcome of the U.S. study. Full Details |
| |  | GSK receives notice from IRS on tax allocation dispute | | | Wednesday 07 January 2004, London - GlaxoSmithKline (GSK) announced today that, as part of its long-running dispute with the US Internal Revenue Service (IRS), the company has now received a claim for additional taxes that the US government asserts legacy company, Glaxo Wellcome owes for the years 1989 to 1996. Full Details |
| |  | New data on Ebixa® for mild to moderate Alzheimer’s disease | | | 07-01-2004 -- Preliminary results from two phase III studies investigating Ebixa® (memantine) in the treatment of mild to moderate Alzheimer's disease were today announced by Forest Laboratories, Inc. and H. Lundbeck A/S respectively. Full Details |
| |  | Sanofi-Synthelabo to acquire all interests in Arixtra®, idraparinux and other oligosaccharides from Organon | | | Paris, january 7, 2004 -- Sanofi-Synthelabo announces today that it has reached agreement with NV Organon to acquire all of Organon interests relating to Arixtra® (fondaparinux sodium), idraparinux and other oligosaccharides such as the hexadecasaccharide. Full Details |
| | | ELOXATIN® is becoming a cornerstone therapy for the treatment of metastatic colorectal cancer in Europe | | | Paris, january 7, 2004 -- Sanofi-Synthélabo announced today that ELOXATIN®, already indicated as a 1st line treatment of metastatic colorectal cancer in major European Countries, has successfully completed a Mutual Recognition Procedure in Europe, which will allow the product to be indicated for the full indication : "Treatment of Metastatic Colorectal Cancer in combination with 5-fluorouracil and folinic acid" (i.e. 1st line and 2nd line treatment). Full Details |
| |  | SICOR Announces Tentative ANDA Approval for Fluconazole Injection | | | IRVINE, Calif., Jan 07, 2004 -- SICOR Inc. (Nasdaq: SCRI) today announced that the Food and Drug Administration (FDA) has issued a tentative approval of an Abbreviated New Drug Application (ANDA) submitted by its wholly owned subsidiary, SICOR Pharmaceuticals, Inc., for fluconazole injection. Fluconazole is an antifungal agent indicated for the treatment of vaginal candidiasis, oropharyngeal and esophageal candidiasis, and cryptococcal meningitis. Full Details |
| Category | | Biotech Companies |
| |  | InterMune Announces New England Journal of Medicine Publication of Phase III Study of Actimmune for Idiopathic Pulmonary Fibrosis | | | BRISBANE, Calif., Jan. 7 -- InterMune, Inc. (Nasdaq: ITMN) today announced the publication, in The New England Journal of Medicine, of previously presented results of the Company's initial randomized, double-blind, placebo-controlled Phase III trial (GIPF-001) evaluating the efficacy and safety of Actimmune(R) (interferon gamma-1b) for the treatment of patients with idiopathic pulmonary fibrosis (IPF), a debilitating and deadly lung disease. Full Details |
| |  | Myriad Genetics and Abbott Laboratories Expand Collaboration | | | SALT LAKE CITY, Jan. 7 -- Myriad Genetics, Inc. (Nasdaq: MYGN), and Abbott Laboratories, Inc. (NYSE: ABT) have expanded their strategic alliance to include a broad new pharmacogenetics program, the Company announced today. The research collaboration will focus on identifying genetic variation within the general population around drug targets in various stages of development. Abbott will fund all research under this collaboration and will retain sole ownership of the results. Myriad will receive a first right on personalized medicine products for reference lab uses that result from the collaboration. Full Details |
| Category | | University/Hospitals |
| |  | Study supports tailoring adjuvant therapy for early-stage breast cancer | | | January 5, 2004 -- Premenopausal women with lymph node-negative breast cancer should receive adjuvant therapy tailored according to the estrogen receptor status of the primary tumor, concludes a study by the International Breast Cancer Study Group (IBCSG) reported in the Dec. 17 issue of the Journal of the National Cancer Institute. Full Details |
| |  | Promising Drug Fails to Thwart Fatal Lung Disease | | | 1/8/2004 | DURHAM, N.C. -- A treatment that hadshown early promise in alleviating symptoms and preventing the advance of thefatal lung disease pulmonary fibrosis failed to stall the disorder's progressionin 162 patients, according to the results of an international clinical trialreported in the Jan. 8, 2004, issue of TheNew England Journal of Medicine. Full Details |
| |  | Using fMRI Technology to Understand Hyperlexia | | | January 8, 2004 | Washington, D.C. -- Georgetown University Medical Center researchers today published the first ever fMRI study of hyperlexia, a rare condition in which children with some degree of autism display extremely precocious reading skills. Appearing in Neuron, the case study uncovers the neural mechanisms that underlie hyperlexia, and suggest that hyperlexia is the true opposite of the reading disability dyslexia. Full Details |
| |  | Gene Technique Targets Alzheimer’s Memory Loss | | | January 6, 2004 | CHICAGO --- Northwestern University researchers have prevented learning and memory deficits in a model of Alzheimer’s disease using a gene-targeting approach to block production of beta-amyloid, or “senile,” plaques, one of the hallmarks of the disease. Full Details |
| |  | Feeder-free system for maintaining pluripotency in embryonic stem cells pioneered at Rockefeller University | | | January 5, 2004 -- Human embryonic stem cell (HESC) lines, or cultures, in the U.S. are not suitable for use in the budding field of regenerative medicine. Their creation using mouse feeder cells, a specialized growth medium, allows scientists to study their basic characteristics, but ultimately the HESCs are too risky to develop in applied medicine because mouse-associated viruses possibly contaminate them. Full Details |
| |  | The common cold as cancer fighter? SLU prof's lifetime work moving into clinical trials | | | Wed, January 7 | ST. LOUIS - Can the common cold ever be a good thing? It is if you've figured out a way to genetically engineer the virus so that it fights and kills cancerous cells - while leaving healthy cells intact. Full Details |
| |  | Researchers Identify Key Risk Factor for Cataracts | | | St. Louis, Jan. 5, 2004 — Ophthalmology researchers at Washington University School of Medicine in St. Louis have identified a key risk factor for the development of cataracts. For the first time, they have demonstrated an association between loss of gel in the eye’s vitreous body — the gel that lies between the back of the lens and the retina — and the formation of nuclear cataracts, the most common type of age-related cataracts. Full Details |
| Category | | Professional Associations |
| |  | Delelopment Of ICSI-Conceived, Pre-School-Age Children Similar To That Of IVF And Naturally-Conceived Children | | | Belgian researchers compared the development of young children conceived using ICSI to that of children conceived naturally or through IVF and found that there were no significant differences. This pilot study is the first to assess the intellectual development of ICSI-conceived children. Full Details |
| |  | New UK cancer statistics releases for year 2000 | | | 7 January 2004 -- THE SHIFTING patterns of cancer diagnosis over recent years are revealed by new figures released by Cancer Research UK and compiled by the UK Association of Cancer Registries. Full Details |
| Category | | Professional Journals |
| |  | A global toolkit for testing gene function | | | We have the complete sequence of the human genome, but as yet only a sketchy idea how the complete set of human genes work to produce and sustain humans in health and disease. We occasionally get a clue when we become aware of a genetic variant that causes disease by blocking the expression of the information contained in a particular gene. Full Details |
| |  | Making LIGHT of cancer | | | Most solid tumors present your immune system with a formidable barrier. Hidden, the tumor can better survive, grow and progress. Scientists have managed to breach the barrier and get impressive tumor regression in mice that is mediated by the immune system. Full Details |
| Category | | Diagnostic Companies |
| |  | Ciphergen Announces Issuance of Patent for Protein Pattern Recognition Combined with Mass Spectrometry | | | Fremont, CA, January 7, 2004 — Ciphergen Biosystems, Inc. (Nasdaq: CIPH) announced today that the United States Patent and Trademark Office has issued Ciphergen U.S. Patent 6,675,104, directed to finding protein patterns in mass spectrometry data. The patent covers software and methods that use a pattern recognition algorithm, called “classification and regression tree analysis” or CART, to identify diagnostic patterns of proteins derived from mass spectrometry data. Full Details |
| |  | FDA Approves Engineering Enhancements To World Heart's Novacor ® LVAS | | | Oakland , California – January 7, 2004 (OTCBB: WHTOF, TSX: WHT) - World Heart Corporation (WorldHeart or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Pre-market Approval Supplement submission to incorporate several engineering enhancements to the implanted and external components of its Novacor ® LVAS (left ventricular assist system). Full Details |
| |  | Andrx and Takeda Collaborate on Combination Product of Actos and Fortamet | | | FORT LAUDERDALE, Fla. | Jan. 7, 2004--Andrx Corporation, Fort Lauderdale, FL, ("Andrx"), (Nasdaq:ADRX) and Takeda Chemical Industries, Ltd., Osaka, Japan ("Takeda"), (TSE:4502) jointly announce today that they have entered into an agreement to develop and market a combination product consisting of Takeda's Actos(R) (Pioglitazone) and Andrx's Fortamet(R) (Metformin Extended Release), each of which is administered once-a-day for the treatment of type 2 diabetes. Full Details |
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