Efficacy News and Research

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Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent "refuse to file" (RTF) letter issued by the Food and Drug Administration (FDA) regarding Merck Serono's oral cladribine has heightened the competition between oral cladribine and its primary competitor, Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), to be the first oral disease-modifying multiple sclerosis therapy to reach the market in the United States.

6 Jan 2010

More research needed to assess psychological debriefing in schools

There is no evidence to support psychological debriefing in schools after traumatic events such as violence, suicides and accidental death, which runs counter to current practice in some Canadian school jurisdictions, according to a commentary http://www.cmaj.ca/embargo/cmaj091621.pdf in CMAJ (Canadian Medical Association Journal) www.cmaj.ca .

6 Jan 2010

Innexus Biotechnology designs new psoriasis product

InNexus Biotechnology Inc. (TSX.V: IXS) (www.ixsbio.com), a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL™) technology, today announced the development of a new psoriasis product based on its proprietary dermal permeating Transmab™ technology.

6 Jan 2010

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD).

6 Jan 2010

OncoMed Pharmaceuticals and Fluidigm announce new initiative to analyze tumor cell heterogeneity

OncoMed Pharmaceuticals, Inc. and Fluidigm Corporation today announced a new initiative to apply Fluidigm's unique microfluidic tools to the analysis of tumor cell heterogeneity, including cancer stem cells.

6 Jan 2010

Phase I clinical trial for Intellikine's INK128 inhibitor initiated

Intellikine, Inc. has initiated a Phase I clinical trial for its targeted anticancer drug INK128, a novel orally-available small molecule inhibitor of both the TORC1 and TORC2 complexes, key components of the PI3K/mTOR signaling pathway.

6 Jan 2010

Scott & White's CRI launches two clinical trials targeting cancers

Scott & White's Cancer Research Institute (CRI) has launched two clinical trials targeting cancers that affect both adults and children.

6 Jan 2010

Excaliard Pharmaceuticals initiates Phase 2 trials of EXC 001

Excaliard Pharmaceuticals, Inc. announced today the initiation of three proof of concept Phase 2 trials of EXC 001, an antisense medicine that reduces fibrosis, for the amelioration of skin scarring and other fibrotic disorders.

6 Jan 2010

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

EnVivo Pharmaceuticals today announced the initiation and dosing of patients in a Phase 2b study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with schizophrenia. EnVivo is conducting the multi-center, dose ranging, placebo controlled, three-month study in the U.S. and Europe.

6 Jan 2010

Study indicates efficacy of antidepressants varies significantly depending on symptom severity

An analysis of randomized trials indicates that compared with placebo, the magnitude of benefit of antidepressant medications varies with the severity of depressive symptoms, and may provide little benefit for patients with mild or moderate depression, but appear to provide substantial benefit for patients with very severe depression, according to an article in the January 6 issue of JAMA.

6 Jan 2010

IBI initiates Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090

Icon Bioscience, Inc., (IBI), a privately held biopharmaceutical company that specializes in the development and commercialization of novel ophthalmic pharmaceuticals announced today that it has initiated its Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090 in patients undergoing cataract surgery.

6 Jan 2010

Quercetin may prevent hepatitis C infection; findings may lead to less toxic treatments

Researchers have identified two cellular proteins that are important factors in hepatitis C virus infection, a finding that may result in the approval of new and less toxic treatments for the disease, which can lead to liver cancer and cirrhosis.

6 Jan 2010

IME introduces new drug-free pain relief alternative for headache

Innovative Medical Equipment, LLC. (IME) today announced the full U.S. market release of SOOTHEAWAY - a new, thermo-electrically heated and cooled therapy device that helps relieve migraine, tension or stress headache pain in the forehead, temples, occipital and ocular / sinus regions.

6 Jan 2010

Enrollment for sham-controlled study of radiation therapy for treatment of wet AMD announced

Oraya Therapeutics, Inc., announced today that enrollment is now underway for the first ever masked and sham-controlled study to demonstrate the efficacy and safety of radiation therapy for the treatment of wet age-related macular degeneration (AMD).

6 Jan 2010

ARYx Therapeutics receives guidance in writing from FDA on tecarfarin

ARYx Therapeutics, Inc., a biopharmaceutical company, today announced that is has received guidance in writing from the U.S. Food and Drug Administration (FDA) confirming that the existing development pathway remains acceptable to seek regulatory approval of ARYx’s novel anticoagulant agent, tecarfarin (ATI-5923).

5 Jan 2010

Phase 2 study evaluating VBL Therapeutics' lead compound VB-201 initiated

VBL Therapeutics today announced the initiation of a Phase 2 efficacy and safety study evaluating lead compound VB-201 for the treatment of patients with psoriasis. VB-201 is poised to be a first-in-class, orally-administered immune response modifier expected to reduce inflammation in a broad range of conditions such as psoriasis.

5 Jan 2010

Author evaluates potential benefits of IAD for treating prostate cancer

'Potential Benefits of Intermittent Androgen Suppression Therapy in the Treatment of Prostate Cancer: A Systematic Review of the Literature' is the title of an article by P-A. Abrahamsson in the January issue of European Urology, the official journal of the European Association of Urology. The author evaluates available evidence regarding the efficacy and tolerability of intermittent androgen deprivation (IAD) and assess its value in the treatment of prostate cancer (PCa).

5 Jan 2010

Study shows increasing number of U.S. adults are taking antidepressants and antipsychotic medications

An increasing number of U.S. adults are being prescribed combinations of antidepressants and antipsychotic medications, according to a report in the January issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

5 Jan 2010

Coformulation of rilpivirine and Truvada HIV drugs will achieve sales of more than $2 billion in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in 2018, the fixed dose coformulation of Tibotec's rilpivirine and Gilead's Truvada will achieve blockbuster sales of more than $2 billion in the HIV drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

5 Jan 2010

Significant opportunity for alternative ulcerative colitis biological therapy

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a biological therapy with a mechanism of action other than tumor necrosis factor alpha (TNF-alpha) inhibition for the treatment of moderate to severe ulcerative colitis, would earn a 25 percent patient share according to surveyed U.S. gastroenterologists. Similarly, in Europe, such an agent would also earn 25 percent patient share according to surveyed European gastroenterologists.

5 Jan 2010

Efficacy News and Research

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

More research needed to assess psychological debriefing in schools

Innexus Biotechnology designs new psoriasis product

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

OncoMed Pharmaceuticals and Fluidigm announce new initiative to analyze tumor cell heterogeneity

Phase I clinical trial for Intellikine's INK128 inhibitor initiated

Scott & White's CRI launches two clinical trials targeting cancers

Excaliard Pharmaceuticals initiates Phase 2 trials of EXC 001

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

Study indicates efficacy of antidepressants varies significantly depending on symptom severity

IBI initiates Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090

Quercetin may prevent hepatitis C infection; findings may lead to less toxic treatments

IME introduces new drug-free pain relief alternative for headache

Enrollment for sham-controlled study of radiation therapy for treatment of wet AMD announced

ARYx Therapeutics receives guidance in writing from FDA on tecarfarin

Phase 2 study evaluating VBL Therapeutics' lead compound VB-201 initiated

Author evaluates potential benefits of IAD for treating prostate cancer

Study shows increasing number of U.S. adults are taking antidepressants and antipsychotic medications

Coformulation of rilpivirine and Truvada HIV drugs will achieve sales of more than $2 billion in 2018

Significant opportunity for alternative ulcerative colitis biological therapy

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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