Copyright 2008 Medical News Today Latest Pharma Industry / Biotech Industry News From Medical News Today. http://www.medicalnewstoday.com/sections/pharma_industry/ admin@medicalnewstoday.com (MNT Admin) editors@medicalnewstoday.com (MNT Editors) en-us Sat, 06 Sep 2008 08:00:00 PDT http://www.medicalnewstoday.com/articles/120527.php Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), issued a statement in response to the Food and Drug Administration (FDA) safety announcement regarding opportunistic fungal infections in patients treated with Tumor Necrosis Factor (TNF) blockers [marketed as Remicade® (infliximab), Enbrel® (etanercept), Humira® (adalimumab) and Cimzia® (certolizumab pegol)]. Arthritis / Rheumatology Sat, 06 Sep 2008 05:00:00 PDT http://www.medicalnewstoday.com/articles/120356.php The U.S. Pharmacopeial (USP) Convention's 2008 Annual Scientific Meeting (ASM) will be held in Kansas City, Mo., September 24 to 26. The meeting is an opportunity to interact with the USP experts responsible for establishing internationally recognized standards for prescription and over-the-counter medicines, food ingredients and dietary supplements. The focus will be on Quality of Manufactured Medicines, Food Ingredients and Dietary Supplements. Pharma Industry / Biotech Industry Sat, 06 Sep 2008 03:00:00 PDT http://www.medicalnewstoday.com/articles/120522.php Research and Markets has announced the addition of the "Biopharmaceuticals in the US and European Markets" report to their offering. Pharma Industry / Biotech Industry Sat, 06 Sep 2008 01:00:00 PDT http://www.medicalnewstoday.com/articles/120546.php SARcode Corporation, a private company focused on small molecule LFA-1 inhibitors to treat inflammatory diseases, and Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced SARcode's initiation of a Phase 1 clinical trial of a small molecule LFA-1 product candidate for T-cell mediated ophthalmic diseases. Eye Health / Blindness Sat, 06 Sep 2008 01:00:00 PDT http://www.medicalnewstoday.com/articles/120555.php The U.S. Food & Drug Administration (FDA) has approved the Roche COBAS(R) TaqMan(R) HBV Test, the first assay for quantitating Hepatitis B Virus DNA approved in the U.S. The test uses Roche's real-time PCR technology to quantify the amount of Hepatitis B virus DNA in a patient's blood. Doctors may use viral load testing results to establish a baseline level of infection and during treatment as an aid in assessing individual responses to therapy. Liver Disease / Hepatitis Sat, 06 Sep 2008 01:00:00 PDT http://www.medicalnewstoday.com/articles/120558.php Celator Pharmaceuticals announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for the treatment of Acute Myeloid Leukemia (AML). Celator is currently preparing to conduct two randomized Phase 2 studies with CPX-351. The first Phase 2 study, in newly diagnosed, elderly patients with AML, is expected to start enrolling patients before the end of 2008. Lymphoma / Leukemia Fri, 05 Sep 2008 11:00:00 PDT http://www.medicalnewstoday.com/articles/120447.php A patent request from the pharmaceutical company Gilead for its antiretroviral drug tenofovir was rejected by Brazil Wednesday, Reuters reports. After announcing the decision, a HIV / AIDS Fri, 05 Sep 2008 04:00:00 PDT http://www.medicalnewstoday.com/articles/120339.php BioCryst Pharmaceuticals (Nasdaq: BCRX) announced results from the completed Phase IIa trial of BCX-4208 in patients with moderate to severe plaque psoriasis. Consistent with interim findings reported in May 2008, this study of BCX-4208, a potent, rationally designed, orally available purine nucleoside phosphorylase (PNP) inhibitor, met its primary objectives of safety and tolerability. Dermatology Fri, 05 Sep 2008 04:00:00 PDT http://www.medicalnewstoday.com/articles/120342.php Agile Therapeutics, Inc., announced that it successfully completed two key clinical trials in the development of the company's new, innovative low-dose, once-weekly, contraceptive patch, which the company refers to by its internal product code AG-200-15. The Phase 2b safety and efficacy study successfully met its primary endpoint of ovulation suppression, cycle control and safety. Sexual Health / STDs Fri, 05 Sep 2008 04:00:00 PDT http://www.medicalnewstoday.com/articles/120353.php Axentis Pharma AG has initiated a clinical phase IIa trial to assess the safety and tolerability of a new therapeutic formulation for the treatment of severe pulmonary infection in cystic fibrosis patients. The new formulation allows an established therapeutic agent to be delivered directly to the site of infection. The forthcoming trial will also compare the effects of two different doses of the new drug. Initial results are expected in summer 2009. Respiratory / Asthma Fri, 05 Sep 2008 04:00:00 PDT http://www.medicalnewstoday.com/articles/120363.php QuatRx Pharmaceuticals, a privately-held biopharmaceutical company focused on development and commercialization of compounds to treat endocrine, metabolic and cardiovascular disorders, announced that it has initiated a second Phase 3 clinical trial of Ophena(TM) (ospemifene tablets), the company's estrogen-free oral therapy in development for the treatment of vaginal symptoms associated with menopause. Women's Health / Gynecology Fri, 05 Sep 2008 04:00:00 PDT http://www.medicalnewstoday.com/articles/120393.php As part of its commitment to providing its customers with comprehensive services that span the entire clinical supply chain, Bilcare Global Clinical Supplies, a leading single-source provider of clinical trial supplies and services, has enhanced its global Phase III capabilities.  Its latest Phase III investments include the upgrade of its Kalish large-scale bottling line at its U.S. Clinical Trials / Drug Trials Fri, 05 Sep 2008 03:00:00 PDT http://www.medicalnewstoday.com/articles/120335.php Medarex, Inc. (Nasdaq: MEDX) announced that nine clinical abstracts for ipilimumab, an investigational anti-CTLA-4 antibody, in melanoma are scheduled to be the subject of presentations at the 33rd Congress of the European Society for Medical Oncology (ESMO) being held September 12-16, 2008 in Stockholm. Dermatology Fri, 05 Sep 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/120331.php UCLA scientists have succeeded in making unique nanoscale droplets that are much smaller than a human cell and can potentially be used to deliver pharmaceuticals. "What we found that was unexpected was within each oil droplet there was also a water droplet - a double emulsion," said Timothy Deming, professor and chair of the UCLA Department of Bioengineering and a member of both the California NanoSystems Institute (CNSI) at UCLA and UCLA's Jonsson Cancer Center. Biology / Biochemistry Fri, 05 Sep 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/120333.php Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) announced that it has enrolled the first subject into its second pivotal Phase 3 clinical trial evaluating Bronchitol in cystic fibrosis sufferers. The Phase 3 trial is being conducted in 41 hospitals across North America, Argentina and Germany, and is the final clinical step before Pharmaxis seeks approval to market Bronchitol for cystic fibrosis in the United States. Cystic Fibrosis Fri, 05 Sep 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/120336.php Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, announced that it has completed the proof-of-concept study evaluating IDX899, a non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for the treatment of HIV-1. HIV / AIDS Fri, 05 Sep 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/120345.php United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary Lung Rx, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for inhaled treprostinil for the treatment of pulmonary arterial hypertension. The NDA will be subject to a standard review period of 10 months, with a targeted user fee deadline of April 30, 2009. Hypertension Thu, 04 Sep 2008 06:00:00 PDT http://www.medicalnewstoday.com/articles/120234.php New drugs that receive fast track designation by the U.S. Food and Drug Administration (FDA) experience shorter clinical and approval times compared to drugs without the designation, according to a recently completed study of the first decade of the fast track program conducted by the Tufts Center for the Study of Drug Development. Total average clinical and approval time for fast track drugs was 5% faster than for all drugs -- 73.1 vs. 77. Pharma Industry / Biotech Industry Thu, 04 Sep 2008 04:00:00 PDT http://www.medicalnewstoday.com/articles/120206.php The best place to seek novel compounds for pharmaceutical drugs, alternative energy sources, and a host of industrial applications, is within natural systems that have evolved over millions of years. Pharma Industry / Biotech Industry Thu, 04 Sep 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/120165.php Nanotechnology and synthetic biology are two of the most exciting fields in science. They are the focus of venture capitalists, government and university laboratories, major corporations, and startup companies. Conferences Thu, 04 Sep 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/120104.php CV Therapeutics, Inc. (Nasdaq: CVTX) announced that the company has enrolled the first patient in a Phase 1 trial of CVT-3619, a novel oral compound for potential treatment of cardiometabolic diseases. The U.S. Food and Drug Administration recently accepted the Company's investigational new drug application for CVT-3619, a partial A1 adenosine receptor agonist. Cardiovascular / Cardiology Thu, 04 Sep 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/120124.php This Analysis Showed That Multaq(R) (Dronedarone) Decreased the Risk of Stroke by 34% in Patients With Atrial Fibrillation or Atrial Flutter Already Adequately Treated by Antithrombotic Therapy The results of a post-hoc analysis of the data from the ATHENA study were presented today at the clinical trial update session of the European Society of Cardiology congress 2008, in Munich, Germany. Stroke / Neuroprotection Thu, 04 Sep 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/120127.php Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD). Respiratory / Asthma Thu, 04 Sep 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/120129.php A sub-analysis of the TRITON-TIMI 38 clinical trial showed that treatment with prasugrel compared with clopidogrel significantly reduced the risk of new or recurrent heart attacks (7.4 percent vs. 9.7 percent, p Cardiovascular / Cardiology Wed, 03 Sep 2008 11:00:00 PDT http://www.medicalnewstoday.com/articles/120070.php Whistle-blowers have helped the Department of Justice recover at least $9.3 billion from health care providers and pharmaceutical companies that allegedly defrauded states and the federal government, according to a report published recently in the Annals of Internal Medicine, the Primary Care / General Practice