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Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

New endoscopic ablation technique safe and effective for treating Barrett's esophagus

Early tumor formation in Barrett's esophagus (BE) can be effectively and safely treated with radiofrequency ablation (RFA), in combination with prior endoscopic removal of visible lesions, according to a new study in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute.

19 Feb 2010

Standard checklist for home palliative sedation

Can patients near death safely receive sedation at home, fully respecting their own and their families' wishes? This practice, which is on the rise, is coming under increasing scrutiny and debate by palliative care researchers and practitioners.

19 Feb 2010

ARYx Therapeutics retains Cowen's services to optimize late-stage asset value

ARYx Therapeutics Inc., a biopharmaceutical company, today announced that it has retained Cowen and Company to explore strategic options for ARYx.

19 Feb 2010

Gladstone MD receives Potamkin Prize for identifying new avenues in Alzheimer's research

Lennart Mucke, MD, Director of the Gladstone Institute of Neurological Disease (GIND), has been named a recipient of the American Academy of Neurology's prestigious Potamkin Prize.

19 Feb 2010

Combination therapy that delays nursing home admission for AD earns 43% patient share in U.S. and 30% in Europe

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of moderate to severe Alzheimer's disease, a combination therapy that delays nursing home admission at 19 months would earn 43 percent patient share, according to surveyed U.S. neurologists. In comparison, in Europe, such an agent would earn a slightly lower patient share of 30 percent, according to surveyed European neurologists. This lower share estimate is possibly a result of higher price sensitivity of European markets.

18 Feb 2010

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

Efficacy News and Research

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

New endoscopic ablation technique safe and effective for treating Barrett's esophagus

Standard checklist for home palliative sedation

ARYx Therapeutics retains Cowen's services to optimize late-stage asset value

Gladstone MD receives Potamkin Prize for identifying new avenues in Alzheimer's research

Combination therapy that delays nursing home admission for AD earns 43% patient share in U.S. and 30% in Europe

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

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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