Efficacy News and Research

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Telaprevir effective in HCV patients

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that data from recent clinical trials suggest that Vertex/Johnson & Johnson/Mitsubishi Tanabe's telaprevir is efficacious in hepatitis C virus patients who have not responded to previous treatment with peg-IFN/ribavirin. In contrast, the efficacy of Merck's (formerly Schering-Plough) boceprevir in treatment nonresponders has yet to be proven.

20 Jan 2010

New pre-clinical data on RXi Pharmaceuticals' proprietary rxRNA compounds presented

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that new pre-clinical data using proprietary rxRNA™ compounds was presented at the Keystone Symposia’s RNA Silencing: Mechanism, Biology and Application held January 14-19 in Keystone, Colorado.

20 Jan 2010

Cardiac RSR test can quickly and accurately detect the presence of S-CAD

Testing a patient's cardiac respiratory stress response (RSR) can quickly and accurately detect the presence of significant coronary artery disease (S-CAD), according to new research published in the current issue of Cardiovascular Revascularization Medicine.

20 Jan 2010

Fc engineering enhances antibody half-life

A Nature Biotechnology article published online January 17 reveals that Xencor Inc.’s proprietary Fc engineering extends the half-life of antibodies while maintaining their potency and extending duration of action. These results, published in an article entitled, “Enhanced antibody half-life improves in vivo activity” demonstrate the potential of Fc engineering to impact the flexibility of route, schedule and dose for nearly any antibody.

20 Jan 2010

Access Pharmaceuticals provides update on its Cobalamin insulin development program

ACCESS PHARMACEUTICALS, INC. provided an update today on its Cobalamin™ oral drug delivery product development programs. The proprietary Cobalamin™ technology utilizes the body's natural vitamin B12 oral uptake mechanism to facilitate oral absorption of pharmaceuticals by a "Trojan horse" mechanism.

20 Jan 2010

U.S. gastroenterologists to treat hepatitis C patients with telaprevir

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that U.S. gastroenterologists will treat a larger proportion of treatment nonresponder hepatitis C patients with Vertex/Tibotec/Mitsubishi Tanabe's telaprevir than Merck's boceprevir.

20 Jan 2010

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Depomed, Inc. announced today it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes.

20 Jan 2010

Alnylam Pharmaceuticals presents data on multiple therapeutic programs at RNAi Symposium

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today announced that it presented data from multiple pre-clinical and clinical programs at the “RNA Silencing: Mechanism, Biology, and Application” Keystone Symposium held January 14-19, 2010 in Keystone, Colorado. Alnylam and its collaborators presented data from Alnylam’s therapeutic programs including transthyretin (TTR)-mediated amyloidosis and Huntington’s disease, as well as new data on delivery approaches for the systemic delivery of RNAi therapeutics.

20 Jan 2010

Patient enrollment for Phase 2B clinical study of Oramed Pharmaceuticals' ORMD-0801 completed

Oramed Pharmaceuticals Inc. announced today the completion of patient enrollment in the Phase 2B clinical study of its oral insulin capsule, ORMD-0801.

20 Jan 2010

Novartis obtains exclusive worldwide rights to develop and commercialize Chiasma's TPE technology

Chiasma, Inc., a privately held biopharma company, announced today that it has granted Novartis an option to obtain exclusive worldwide rights to develop and commercialize the Company's Transient Permeability Enhancer (TPE) technology for use with certain related small molecule products either in development or currently marketed by Novartis.

19 Jan 2010

DURECT commences dosing in its POSIDUR Phase III clinical trial

DURECT Corporation announced today that it has begun dosing patients in its U.S. pivotal Phase III clinical trial to evaluate POSIDUR™ (SABER™-Bupivacaine), an investigational drug, for the treatment of post-surgical pain. The pivotal trial, referred to as BESST (Bupivacaine Effectiveness and Safety in SABER Trial), is an international, multi-center, randomized, double-blind, controlled trial evaluating the safety, efficacy, effectiveness, and pharmacokinetics of POSIDUR in patients undergoing general surgical procedures.

19 Jan 2010

Gastric bypass surgery may increase life expectancy of morbidly obese individuals

A computerized model suggests that most morbidly obese individuals would likely live longer if they had gastric bypass surgery, according to a report in the January issue of Archives of Surgery, one of the JAMA/Archives journals. However, the best decision for individual patients varies based on factors such as age, increasing body mass index and the effectiveness of surgery.

19 Jan 2010

HolGenTech PGA for Genome Based Economy to be presented at the Personalized Medicine World Conference

HolGenTech, a leader in Genome Computing Architecture, will demonstrate the world's first Personal Genome Assistant (PGA) for the Genome Based Economy at the inaugural event of the Personalized Medicine World Conference at the Mountain View Computer History Museum, January 19-20. Designed to automate best choices for consumers as they shop for food, nutrients, cosmetics and more, the HolGenTech PGA leverages data from genomic tests, health database services, and user preferences to equip consumers with a practical tool to optimize health and maximize prevention.

19 Jan 2010

Scientists launch NEWMEDS project to develop drugs for schizophrenia and depression

An international consortium of scientists, led by H. Lundbeck A/S and King's College London, has launched one of the largest ever research academic-industry collaboration projects to find new methods for the development of drugs for schizophrenia and depression.

19 Jan 2010

Enrollment of Phase 2 portion of Cempra Pharmaceuticals' Phase 2/3 clinical trial of TAKSTA completed

Cempra Pharmaceuticals today announced completion of enrollment of the Phase 2 portion of its Phase 2/3 clinical trial of TAKSTA (sodium fusidate; CEM-102) for the treatment of acute bacterial skin and skin structure infections.

19 Jan 2010

Calsed earns proprietary clinical gold standard status from Decision Resources

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Celgene/Nippon Kayaku's Calsed earns Decision Resources' proprietary clinical gold standard status in 2013 for the treatment of extensive-disease small-cell lung cancer, following its approval for the indication in 2012.

19 Jan 2010

Psoriasis therapy costs outpace inflation

Findings from a cost model suggest that expenses for systemic psoriasis therapy appear to be increasing at a faster rate than inflation, and newer biologically derived treatments are more expensive than traditional systemic therapies, according to a report in the January issue of Archives of Dermatology, one of the JAMA/Archives journals.

19 Jan 2010

Testing for high-risk types of HPV DNA can be effective in preventing invasive cervical cancer

Results from a study of more than 90,000 Italian women published by the Lancet Oncology found that testing for high-risk types of the human papillomavirus (HPV) DNA is significantly more effective in preventing invasive cervical cancer than cytology (Pap testing) alone.

19 Jan 2010

Sodium oxybate to garner over 15% of the fibromyalgia drug market despite safety concerns

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite potential safety concerns, Jazz Pharmaceuticals/UCB's sodium oxybate (JZP-6) will account for more than 15 percent of the fibromyalgia drug market in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Sodium oxybate has demonstrated robust efficacy in Phase III clinical trials for fibromyalgia and interviewed thought leaders are impressed with its effect on several key symptom domains of fibromyalgia, which include pain, sleep and fatigue.

18 Jan 2010

ERT Knowledge Series of educational papers discusses patient safety in clinical trials

ERT, a leading provider of centralized services to the biopharmaceutical, medical device and related industries, today announced its new ERT Knowledge Series of educational papers, written by ERT experts. Each paper discusses issues relevant to patient safety in clinical trials today and further establishes ERT as an experienced and reliable partner in products and services for the clinical trials industry.

18 Jan 2010

Efficacy News and Research

Telaprevir effective in HCV patients

New pre-clinical data on RXi Pharmaceuticals' proprietary rxRNA compounds presented

Cardiac RSR test can quickly and accurately detect the presence of S-CAD

Fc engineering enhances antibody half-life

Access Pharmaceuticals provides update on its Cobalamin insulin development program

U.S. gastroenterologists to treat hepatitis C patients with telaprevir

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Alnylam Pharmaceuticals presents data on multiple therapeutic programs at RNAi Symposium

Patient enrollment for Phase 2B clinical study of Oramed Pharmaceuticals' ORMD-0801 completed

Novartis obtains exclusive worldwide rights to develop and commercialize Chiasma's TPE technology

DURECT commences dosing in its POSIDUR Phase III clinical trial

Gastric bypass surgery may increase life expectancy of morbidly obese individuals

HolGenTech PGA for Genome Based Economy to be presented at the Personalized Medicine World Conference

Scientists launch NEWMEDS project to develop drugs for schizophrenia and depression

Enrollment of Phase 2 portion of Cempra Pharmaceuticals' Phase 2/3 clinical trial of TAKSTA completed

Calsed earns proprietary clinical gold standard status from Decision Resources

Psoriasis therapy costs outpace inflation

Testing for high-risk types of HPV DNA can be effective in preventing invasive cervical cancer

Sodium oxybate to garner over 15% of the fibromyalgia drug market despite safety concerns

ERT Knowledge Series of educational papers discusses patient safety in clinical trials

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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