Efficacy News and Research

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Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

Nanotechnology plays a key role in detection and treatment of cancer

A world-renowned medical researcher discusses the key role that nanotechnology has begun to play in the detection and treatment of cancer in an article that will appear in the March 2010 edition of Mechanical Engineering magazine.

18 Feb 2010

Catalyst Pharmaceutical Partners to present overview of CPP-115 compound at epilepsy conference

Catalyst Pharmaceutical Partners, Inc. announced today that it was selected by both the Scientific and Business Advisory Boards of the Epilepsy Therapy Project to present at the 2010 Epilepsy Pipeline Update Conference, an in-depth, two day forum to be held February 25-26, 2010, at the Hyatt Embarcadero Hotel in San Francisco.

18 Feb 2010

NCI's NCL to conduct characterization studies of Celator Pharmaceuticals' HDPN formulation

Celator Pharmaceuticals today announced that the National Cancer Institute's (NCI) Nanotechnology Characterization Laboratory (NCL), operated by SAIC-Frederick (Frederick, Maryland), has agreed to conduct characterization studies to advance the development of the company's nanoparticle drug formulation technology.

18 Feb 2010

Study demonstrates once-a-week TB drug is as effective as daily dose

Researchers at the Council for Scientific and Industrial Research (CSIR) are one step closer to providing Tuberculosis (TB) sufferers with a once-a-week medicinal regime rather than their current daily doses.

18 Feb 2010

Multiple, independent European blood centers to report on INTERCEPT Blood System for platelets and plasma

Cerus Corporation announced today that investigators from blood centers in Sweden, Belgium, France and Slovenia will present their experience with the INTERCEPT Blood System for platelets and plasma during a leading international transfusion safety meeting, the XIIth International Haemovigilance Seminar taking place in Dubrovnik, Croatia from February 17 to 19.

18 Feb 2010

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults.

18 Feb 2010

Roche completes enrollment in RG7128 Phase 2b PROPEL study

Pharmasset, Inc. announced today the complete enrollment by Roche of the 12 week RG7128 Phase 2b study (PROPEL) of approximately 400 treatment-naive patients with hepatitis C virus (HCV) genotypes 1 and 4. The study remains blinded to Roche and Pharmasset.

17 Feb 2010

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Marcadia Biotech Inc. today announced that it has initiated a Phase 1 clinical trial of MAR701, a novel dual agonist of the incretin hormone receptors for glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Marcadia plans to initially develop this compound as a treatment for type 2 diabetes with once-weekly dosing. The Phase 1 trial will evaluate MAR701 in healthy volunteers at escalating dose levels.

17 Feb 2010

AHF to protest Merck’s Isentress pricing and policies at CROI

AIDS Healthcare Foundation (AHF) will host a protest Wednesday morning, February 17 at 8:00am targeting Merck and Co. Pharmaceuticals over the pricing and policies for its key HIV/AIDS drug, Isentress, the most expensive first-line AIDS treatment in the US, during the 17th Conference of Retroviruses and Opportunistic Infections (CROI) in San Francisco.

17 Feb 2010

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

In a new phase III study, GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16 and 18) Recombinant Vaccine) prevented 77.5 per cent of anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men.

17 Feb 2010

AMAG's Feraheme use on the rise

BioTrends Research Group, Inc. released Wave 3 of its LaunchTrends®: Feraheme report, the third in a multi-phase syndicated market research project tracking the launch of AMAG's new IV iron product, Feraheme, through the first six months of product availability. Each wave of the report provides quantitative information from 50 unique Nephrologists and qualitative information from a subset of 15. The reports assess trial and use of Feraheme, obstacles to use, reasons to use, typical patient types, product perceptions, promotional efforts/messages, and product satisfaction.

17 Feb 2010

Belatacept costimulation blocker can prevent rejection of new organs by the immune system

Initial results of a study conducted at 100 centers worldwide indicate that belatacept, a first-in-class costimulation blocker can prevent the immune system rejecting new organs. The results also suggest that it may provide similar patient and graft survival to cyclosporine but with fewer side effects and superior kidney function after 12 months. The study, published today in the American Journal of Transplantation, provides the first findings to come from BENEFIT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial).

17 Feb 2010

Research suggests scorpion venom could be an alternative to morphine painkiller

Scorpion venom is notoriously poisonous ― but it might be used as an alternative to dangerous and addictive painkillers like morphine, a Tel Aviv University researcher claims.

17 Feb 2010

Effectiveness of influenza vaccines in older people: No clear conclusions

Evidence for the safety and efficacy of influenza vaccines in the over 65s is poor, despite the fact that vaccination has been recommended for the prevention of influenza in older people for the past 40 years. These are the conclusions of a new Cochrane Systematic Review.

17 Feb 2010

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Obecure Ltd (http://www.obecure.com)., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., announced today the execution of a licensing and clinical supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group.

17 Feb 2010

CalciMedica granted U.S. composition patent concerning key component of CRAC channel

CalciMedica today announced that the US Patent and Trademark Office has issued to CalciMedica US Patent No. 7,645,588, a composition patent involving STIM1, a key component of the calcium release-activated calcium (CRAC) channel. The patent, entitled "Composition comprising a cell comprising a STIM1 protein and an agent that modulates intracellular calcium and methods of use," has a priority date of March 4, 2003 and was issued on January 12, 2010.

17 Feb 2010

ITS secures £8.65M Series-A equity funding round extension to fund synthetic flu vaccine study

Immune Targeting Systems (ITS) Limited (“ITS”), one of the leading developers of synthetic vaccines for mutating viruses, today announced it had secured a Series-A equity funding round extension for £8.65m which brings the total Series A financing to £13.15m. The company’s key investors HealthCap (Sweden), London Technology Fund (UK), Novartis Venture Fund (US & Basel) and Truffle Capital (France) are all participating. The round will be kept open until mid-2010 for new potential investors to invest.

17 Feb 2010

Research assesses the overall efficacy of palliative chest RT in patients with advanced NSCLC

Research published in the February edition of the Journal of Thoracic Oncology sought to assess the overall efficacy of split-course palliative chest radiotherapy (RT) for symptom relief in patients with advanced non-small cell lung cancer. Additionally, researchers investigated the impact the regimen's two-week break has on survival outcomes.

17 Feb 2010

Efficacy News and Research

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Nanotechnology plays a key role in detection and treatment of cancer

Catalyst Pharmaceutical Partners to present overview of CPP-115 compound at epilepsy conference

NCI's NCL to conduct characterization studies of Celator Pharmaceuticals' HDPN formulation

Study demonstrates once-a-week TB drug is as effective as daily dose

Multiple, independent European blood centers to report on INTERCEPT Blood System for platelets and plasma

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Roche completes enrollment in RG7128 Phase 2b PROPEL study

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

AHF to protest Merck’s Isentress pricing and policies at CROI

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

AMAG's Feraheme use on the rise

Belatacept costimulation blocker can prevent rejection of new organs by the immune system

Research suggests scorpion venom could be an alternative to morphine painkiller

Effectiveness of influenza vaccines in older people: No clear conclusions

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

CalciMedica granted U.S. composition patent concerning key component of CRAC channel

ITS secures £8.65M Series-A equity funding round extension to fund synthetic flu vaccine study

Research assesses the overall efficacy of palliative chest RT in patients with advanced NSCLC

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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