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Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Acorda Therapeutics, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).

22 Jan 2010

hESC "reporter" line to measure endothelial cell production and activity

New York Stem Cell Foundation (NYSCF)-Druckenmiller Fellow, Daylon James, PhD, of Weill Cornell Medial College, is lead author on a study defining conditions for generating a plentiful supply of endothelial (vessel lining) cells that are suitable for therapeutic use. Dr. James and his colleagues created a human embryonic stem cell (hESC) "reporter" line that can be used to measure endothelial cell production and activity.

22 Jan 2010

Norepinephrine responses to bucindolol influenced by alpha-2C adrenergic receptor genotype

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular disease, today announced that the paper “An alpha-2C-Adrenergic Receptor Polymorphism Alters the Norepinephrine Lowering Effects and Therapeutic Response of the Beta Blocker Bucindolol in Chronic Heart Failure” was published in the January 2010 edition of the peer-reviewed journal Circulation: Heart Failure (http://circheartfailure.ahajournals.org).

22 Jan 2010

CytRx announces its plans to advance multiple oncology development programs in 2010

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

22 Jan 2010

NicOx receives EMEA approval for naproxcinod MAA

NicOx S.A. today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009. NicOx is seeking approval for an indication for the relief of the signs and symptoms of primary osteoarthritis. This follows the acceptance for filing of a New Drug Application (NDA) by the US Food and Drug Administration (FDA) in November 2009.

22 Jan 2010

Study shows usefulness of handheld devices for teleconsultation and emergency procedures

Handheld devices such as personal digital assistants (PDAs) and the iPod Touch are prevalent among doctors. However a recent study shows that these devices may be particularly useful for emergency radiologists, who in the near future, may be able to use them for teleconsultation and emergency procedures, according to a study published in the February issue of the American Journal of Roentgenology.

22 Jan 2010

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

22 Jan 2010

Depomed receives second $500,000 milestone payment from Covidien

Depomed, Inc. announced today that it has received a second $500,000 milestone payment under its worldwide license agreement with Covidien focusing on the exclusive development of four acetaminophen/opioid analgesic combination products utilizing Depomed’s Acuform® gastric retentive drug delivery technology. The most recent payment from Covidien, which was received in December 2009, relates to the development of a formulation for the second product candidate under the collaboration.

21 Jan 2010

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Pharmasset, Inc. today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

21 Jan 2010

Efficacy of neurofeedback in treating ADD/ADHD

On January 22, the Potomac Institute for Policy Studies will present a guest lecture by Don DuRousseau, founder and CEO of Human Bionics LLC, a neurotechnology company specializing in brain-computer interface (BCI) systems. Mr. DuRousseau will explore the use of neurotechnology techniques, including the increasingly popular neurofeedback, as a treatment for ADD/ADHD.

21 Jan 2010

Results of two pivotal Phase III clinical trials with oral FTY720 published

Results of the TRANSFORMS and FREEDOMS studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety profile of this first-in-class therapy for multiple sclerosis (MS).

21 Jan 2010

COTI's novel small molecule effective against pancreatic cancer in animal model

Critical Outcome Technologies Inc. announced more positive results today from animal experiments carried out at a prominent Canadian cancer research facility. This new series of experiments adds to the impressive data package for COTI-2, demonstrating efficacy both as a single agent and in combination with current first line therapies, as well as low toxicity in several different animal models of human cancers.

21 Jan 2010

ABC publishes Pycnogenol monograph

The nonprofit American Botanical Council (ABC) has just published a monograph summarizing selected scientific and clinical studies of Pycnogenol®, a patented dietary ingredient from French maritime pine bark.

21 Jan 2010

FDA approves Thoratec's HeartMate II LVAS for DT

Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has received FDA approval of its PMA (Pre-Market Approval) supplement, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT).

21 Jan 2010

Acyclovir does not reduce risk of HIV transmission for people infected with both HIV and HSV-2

A five-year international multi-center clinical trial has found that acyclovir, a drug widely used as a safe and effective treatment taken twice daily to suppress herpes simplex virus-2 (HSV-2), which is the most common cause of genital herpes, does not reduce the risk of HIV transmission when taken by people infected with both HIV and HSV-2.

21 Jan 2010

Australia issues patent covering Kane Biotech's DispersinB anti-biofilm technology

Kane Biotech Inc., a biotechnology company engaged in the development of products that prevent and disperse microbial biofilms, is pleased to announce the issuance of Patent No. 2003284385 entitled "Compositions and methods for enzymatic detachment of bacterial and fungal biofilms" by IP Australia (Australian Patent and Trademark Office).

21 Jan 2010

Lexicon Pharmaceuticals reports positive results from its LX4211 Phase 2 trial in type 2 diabetic patients

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained positive results from a recently completed Phase 2 study of LX4211 in patients with type 2 diabetes mellitus. LX4211 is a once-per-day, orally-delivered, small molecule drug candidate that inhibits the sodium-dependent glucose transporter 2 (SGLT2), lowering the accumulation of glucose in the body and reducing caloric load.

20 Jan 2010

New LNP compositions that improve systemic delivery of RNAi therapeutics discovered

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today announced the publication of new data in the journal Nature Biotechnology by Alnylam scientists and collaborators from Tekmira Pharmaceuticals Corporation, AlCana Technologies, Inc., and The University of British Columbia (UBC). The new study employed a rational design approach for the discovery of novel lipids that can be incorporated into lipid nanoparticles (LNPs) for systemic delivery of RNAi therapeutics.

20 Jan 2010

Arts-based program identifies safety needs of children from low-income communities

Identifying the public health and safety needs of children from low-income communities may be best accomplished through art, report University of Pittsburgh researchers in the current online issue of Progress in Community Health Partnerships: Research, Education and Action. In their paper, researchers describe the success of Visual Voices, an arts-based program that engages community members as partners in research.

20 Jan 2010

Weight Watchers International files complaint against Jenny Craig

Weight Watchers International, Inc., the global leader in weight-management services, today announced it has filed a complaint in the U.S. District Court for the Southern District of New York for injunctive relief and damages against Jenny Craig, Inc. ("Jenny Craig").

20 Jan 2010

Efficacy News and Research

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

hESC "reporter" line to measure endothelial cell production and activity

Norepinephrine responses to bucindolol influenced by alpha-2C adrenergic receptor genotype

CytRx announces its plans to advance multiple oncology development programs in 2010

NicOx receives EMEA approval for naproxcinod MAA

Study shows usefulness of handheld devices for teleconsultation and emergency procedures

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Depomed receives second $500,000 milestone payment from Covidien

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Efficacy of neurofeedback in treating ADD/ADHD

Results of two pivotal Phase III clinical trials with oral FTY720 published

COTI's novel small molecule effective against pancreatic cancer in animal model

ABC publishes Pycnogenol monograph

FDA approves Thoratec's HeartMate II LVAS for DT

Acyclovir does not reduce risk of HIV transmission for people infected with both HIV and HSV-2

Australia issues patent covering Kane Biotech's DispersinB anti-biofilm technology

Lexicon Pharmaceuticals reports positive results from its LX4211 Phase 2 trial in type 2 diabetic patients

New LNP compositions that improve systemic delivery of RNAi therapeutics discovered

Arts-based program identifies safety needs of children from low-income communities

Weight Watchers International files complaint against Jenny Craig

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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