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Metabolex Announces Positive Results From Phase 2 Clinical Trial Of MBX-8025

Wed, 19 Nov 2008 00:00:00 PST

Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced positive results from a Phase 2 clinical trial of MBX-8025. A summary of the results was presented at the World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy) on November 1, 2008. MBX-8025 is an oral drug candidate that is being evaluated for the treatment of dyslipidemia.

XTL Biopharmaceuticals Announces Top-Line Results From The Bicifadine Phase 2b Study For Diabetic Neuropathic Pain

Wed, 19 Nov 2008 00:00:00 PST

XTL Biopharmaceuticals Ltd. (Nasdaq: XTLB; TASE: XTL) announced the top-line results from the Bicifadine Phase 2b clinical trial for the treatment of diabetic neuropathic pain. The trial's primary objective was to compare the efficacy of two doses of Bicifadine against placebo in reducing pain associated with diabetic neuropathy. The primary endpoint of the study was the reduction in pain score during the course of treatment.

Long-Term TITAN Study Evaluates PREZISTA(R)/ritonavir Vs. Lopinavir/ritonavir As Part Of HIV Combination Therapy In Treatment-Experienced Adults

Wed, 19 Nov 2008 00:00:00 PST

Tibotec recently announced long-term study results from a phase 3 clinical trial, which compared PREZISTA(R) (darunavir)/ritonavir to lopinavir/ritonavir, as part of HIV combination therapy, in lopinavir/r-naive, treatment-experienced HIV-1 infected adults. A 96-week resistance analysis from the study, known as TITAN, was presented in an oral presentation at the Ninth International Congress on Drug Therapy in HIV Infection (HIV9) in Glasgow, UK on November 13, 2008.

Chronic Plaque Psoriasis - 2nd Case Of Progressive Multifocal Leukoencephalopathy In A Raptiva Patient

Tue, 18 Nov 2008 09:00:00 PST

Genentech, Inc. (NYSE:DNA) announced today that the company has issued a Dear Healthcare Provider letter to inform dermatologists and neurologists of a 2nd case of progressive multifocal leukoencephalopathy (PML) which resulted in the death of a 73-year old woman who had received Raptiva® (efalizumab) for approximately four years for treatment of chronic plaque psoriasis.

Cyclosporin Human Neuroprotection Validated By Maas Biolab Scientists

Tue, 18 Nov 2008 09:00:00 PST

Maas Biolab researchers CSO Eskil Elmér, M.D., Ph.D. and neuroscientist Magnus Hansson, M.D., Ph.D., and colleagues have for the first time ever demonstrated the mitochondrial permeability transition (mPT) or "megapore" occurs in viable adult human neuron mitochondria and the ability of cyclosporin-A to block its formation. These effects had previously been well characterized in animal neuroprotection studies and have now been validated in human brain tissue.

8,000 Pharmaceutical Scientists To Gather In Atlanta For The American Association Of Pharmaceutical Scientists' Annual Meeting And Exposition

Tue, 18 Nov 2008 09:00:00 PST

On November 16-20, 2008, 8,000 of the world's most prominent pharmaceutical scientists will put their best research on paper and present their findings at the AAPS Annual Meeting and Exposition. This year's meeting will take place in Atlanta at the Georgia World Congress Center.

ISPE And FDC-Windhover Team Up To Offer PharmAsia News

Tue, 18 Nov 2008 04:00:00 PST

ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, and FDC-Windhover announced today that the two organizations have teamed up to provide discounted subscriptions of PharmAsia News to ISPE Members, as well as complimentary access to monthly articles.

The Future Of Physician Customer Service Portals - Report Reveals Market Data And Best Practices For Biopharma Companies

Tue, 18 Nov 2008 03:00:00 PST

Over the past year, physician visitation to customer service portals decreased while interest in using them actually increased. To help biopharma companies bridge the gap between the current portal landscape and unmet physician demand, Manhattan Research just released its latest physician module report, "The Case for Customer Care: Service Portals and a Successfully Integrated CRM System" as part of its ePharma Physicianâ v8.0 market research and strategic advisory service.

EGFR-Targeting Antibody Licensed To Abbott

Tue, 18 Nov 2008 02:00:00 PST

The international Ludwig Institute for Cancer Research (LICR) has announced that one of its spin-off companies, Life Science Pharmaceuticals, has licensed its lead cancer therapy candidate, antibody 806, to pharmaceutical company Abbott. The 806 antibody targets the EGFR cell surface protein but - crucially - only when the protein is over-expressed (over-produced) in cancer. Overexpression of EGFR occurs in more than 50% of some types of cancers.

Prometheus Presents New Clinical Insights Into Diagnosis Of Crohn's Disease In Children From Analysis Of PROMETHEUS(R) IBD Serology 7 Test Results

Tue, 18 Nov 2008 00:00:00 PST

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced new findings regarding the correlation between serologic markers and the diagnostic predictions of children with Crohn's disease following an analysis of PROMETHEUS(R) IBD Serology 7 test results.

Innocoll Receives Fast Track Designation For Gentamicin Surgical Implant

Tue, 18 Nov 2008 00:00:00 PST

Innocoll, Inc., a privately-held biopharmaceutical company, announced that the FDA has designated Gentamicin SURGICAL Implant as a Fast Track development program. GENTAMICIN SURGICAL IMPLANT is currently being evaluated in two phase III clinical trials as an adjunct to systemic antibiotic administration for the prevention of surgical site infections in patients who are at higher risk of developing surgical site infections.

FREEDOM-C Trial Of Oral Treprostinil In Pulmonary Arterial Hypertension Fails To Meet Primary Endpoint

Tue, 18 Nov 2008 00:00:00 PST

United Therapeutics Corporation (Nasdaq: UTHR) announced the results of the FREEDOM-C trial of oral treprostinil, a sustained-release formulation of treprostinil, in pulmonary arterial hypertension (PAH). Preliminary analysis demonstrates that the trial did not achieve statistical significance for the primary endpoint, six minute walk (6MW) distance at Week 16.

GeneThera Releases Results From Initial Animal Tests Of E.Coli O157:h7 Vaccine Amid News Of Increase Of E.Coli Discoveries In Beef Products

Tue, 18 Nov 2008 00:00:00 PST

GeneThera, Inc. (Pink Sheets: GTHR), released information about its E.Coli O157:H7 vaccine. The vaccine consists of Live Attenuated Bacterial Vaccine to Reduce or Inhibit Carriage and Shedding of Enterohemorrihagic Escherichia Coli in Cattle. This vaccine was developed for use against Shiga toxin-producing E.Coli (STEC) in cattle. This strategy is to construct mutants that have deletion in the genes responsible for E.Coli O157:H7 toxicity.

TOSHIBA Dramatically Advances Biosensor Technology

Mon, 17 Nov 2008 09:00:00 PST

Cambridge Research Laboratory of Toshiba Research Europe Ltd has developed a novel, label-free biosensor platform, which is expected to significantly shorten the total biomolecular assay process, saving days or even weeks of research time. The platform is capable of combining multiple array experiments in one single instance on a wide variety of biomolecules such as antibodies and other proteins.

Roche, Merck Serono And Abbott Join Forces In Biotechnology Cluster Rhine-Neckar (BioRN)

Mon, 17 Nov 2008 08:00:00 PST

At the opening of the BIO-Europe 2008 Partnering Conference, Roche, Merck Serono and Abbott announced today to join forces in the development of the Biotechnology Cluster Rhine-Neckar (BioRN) towards a leading position in the field of medical biotechnology in Europe. The BioRN cluster was recently awarded a 40 million euro federal grant by the German Ministry for Education and Research as one of the top five high-tech clusters in Germany.

The USA Is Still The Preferred Market For Launching New Medical Products

Mon, 17 Nov 2008 04:00:00 PST

While the number of annual new drug approvals in the United States has declined during the past decade, the U.S. remains the preferred market for launching new products, according to a recently completed analysis conducted by the Tufts Center for the Study of Drug Development. The study found that new U.S. drug approvals dropped to 48 in 2005-07, from a peak of 110 in 1996-98.

TIBCO Speeds Drug Discovery For Chemists

Mon, 17 Nov 2008 03:00:00 PST

TIBCO Software Inc. (NASDAQ: TIBX), today announced the release of TIBCO Spotfire® Lead Discovery. The solution allows chemists to quickly access chemistry and biological data in a single analysis environment, then easily build best-practice applications for chemical structure analysis. The solution, built on the powerful TIBCO Spotfire® Enterprise Analytics platform,, integrates with leading cheminformatics software, including Symyx and CambridgeSoft.

New Data On Cancer Diagnostic Presented By Arbor Vita

Mon, 17 Nov 2008 01:00:00 PST

Arbor Vita Corporation (AVC), a privately held biopharmaceutical company, presented new data on its rapid, point-of-care prototype HPV test with a high positive predictive value for cervical cancer and pre-cancer. Targeted for use throughout the developing world, this diagnostic test is being developed in partnership with PATH.

Pfizer Launches Global Regenerative Medicine Research Unit

Mon, 17 Nov 2008 01:00:00 PST

Pfizer today announced the launch of a new research unit known as Pfizer Regenerative Medicine. This independent research unit will build on recent scientific progress in understanding the biology of stem cells and the opportunity that provides, to discover and develop a new generation of regenerative medicines for major medical needs.

Affordable Medicine Plan Goes Global

Mon, 17 Nov 2008 00:00:00 PST

An innovative plan to get new life-saving drugs into the hands of millions of people around the world who need medicines but can't afford the massive costs will be unveiled to key decision makers in London and Washington over the coming weeks.

Pharmaceutical Companies Need To Speed Up Transformation To Meet Changing Market Dynamics, Says Ernst & Young Report

Sun, 16 Nov 2008 00:00:00 PST

Leaders of the largest global pharmaceutical companies recognize the need for transformational change in their organizations, but will need to move swiftly to ensure sustained growth for the sector. Current global financial conditions and the threat of a broad recession have accelerated the timetable for implementing change, as the industry confronts lower corporate stock prices and an increasingly cost-averse customer.

GSK And Xenoport Announce Plans To Withdraw And Resubmit New Drug Application Requesting Approval Of Solzira™ For Restless Legs Syndrome

Sat, 15 Nov 2008 01:00:00 PST

GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced that the New Drug Application (NDA) for Solzira™ (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) has been withdrawn. The United States Food and Drug Administration (FDA) has requested that the data in a single study be reformatted.

Statement By Merck & Co., Inc., In Response To The FDA's Update Regarding A Safety Review On Bisphosphonates Including FOSAMAX®

Sat, 15 Nov 2008 01:00:00 PST

The FDA announced its update on the safety review of bisphosphonates, including FOSAMAX®, that found no clear association between overall bisphosphonate exposure and the rate of serious or non serious atrial fibrillation. Increasing dose or duration of bisphosphonate therapy was also not associated with an increased rate of atrial fibrillation. These findings are based on the Agency's review of data from clinical studies of bisphosphonates.

Rasilez®, First-in-class Direct Renin Inhibitor, Provides Greater Reduction In High Blood Pressure Than ACE Inhibitor Ramipril

Sat, 15 Nov 2008 01:00:00 PST

New clinical data presented show first-in-class direct renin inhibitor Rasilez® (aliskiren), known as Tekturna® in the US, provides significantly greater blood pressure reductions in patients with high blood pressure aged 65 and over, compared to the angiotensin-converting enzyme (ACE) inhibitor ramipril[1].

FDA Approves Low-dose Regimen Of Premarin Vaginal Cream To Treat Moderate To Severe Postmenopausal Dyspareunia Painful Sexual Intercourse

Sat, 15 Nov 2008 01:00:00 PST

PREMARIN® (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).