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EDAP announces placement of first Sonolith i-sys electroconductive lithotripter in South Africa

EDAP TMS SA, the global leader in therapeutic ultrasound, reported today placement of the first Sonolith i-sys electroconductive lithotripter in South Africa.

21 Jan 2011

Major breakthrough: Genome-based medicine for treatment of alcoholism

For the first time in alcohol addiction research, UVA investigators have successfully treated alcohol-dependent individuals with medication that is tailored specifically to match their genetic profile.

21 Jan 2011

Health Canada approves Labopharm's OLEPTRO for treatment of Major Depressive Disorder

Labopharm Inc. today announced that Health Canada's Therapeutic Products Directorate (TPD) has approved OLEPTRO, a novel once-daily formulation of the antidepressant trazodone, for the symptomatic relief of Major Depressive Disorder in adults.

21 Jan 2011

Positive results from nimotuzumab Phase II study for gastric cancer

YM BioSciences, a life sciences product development company advancing a diverse portfolio of promising hematology and cancer-related products at various stages of development, today announced that results were reported from a randomized Phase II gastric cancer study of nimotuzumab being conducted by its licensees, Daiichi Sankyo Co., Ltd. in Japan and Kuhnil Pharma Co. Ltd., in Korea.

21 Jan 2011

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine and Zidovudine Tablets, 30 mg/60 mg.

20 Jan 2011

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. RiVax™ is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.

20 Jan 2011

Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

Chelsea Therapeutics International, Ltd. reported new 12-month data from Study 303, a safety extension study from its Phase III NORTHERA™ (droxidopa) registration program in symptomatic neurogenic orthostatic hypotension (NOH). Preliminary, top-line results demonstrate Northera provides clinically meaningful and durable symptomatic improvements in patients with NOH throughout a one-year observation period.

20 Jan 2011

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

Merck reported today that investigators in the TRA-2P study of vorapaxar have been provided with additional information about the recommendations of the Data and Safety Monitoring Board (DSMB) regarding the TRA-2P study. The additional information was sent yesterday in a communication to investigators from the Operations Committee of the TRA-2P study of vorapaxar. Vorapaxar is one of Merck's investigational cardiovascular medicines.

20 Jan 2011

ISCT launches commercial development focus group addressing Cell Therapies for Peripheral Vascular Disease

In keeping with its commitment to connect industry, regulatory experts, therapeutic societies and translational centers to advance emerging cellular therapies, ISCT announces its first commercial development focus group addressing Cell Therapies for Peripheral Vascular Disease (PVD).

20 Jan 2011

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

Pervasis Therapeutics, Inc. today announced that the company is pursuing a matrix-embedded endothelial cell-based therapy (PVS-30200) to target and regulate cell stroma (the tumor environment or "ecosystem" that is comprised of various supporting cell types distinct from cancer cells) in order to prevent key processes that play a role in advancing solid tumor growth and metastasis.

20 Jan 2011

UMB enters license agreement with Bali BioSciences for new strategy to combat sepsis, HIV/AIDS

The University of Maryland, Baltimore's (UMB) Office of Technology Transfer has completed a license agreement with Bali BioSciences LLC, an early-stage company pursuing an unusual, yet clever, strategy to combat disease.

20 Jan 2011

Precision Therapeutics to present pancreatic cancer data at 2011 ASCO GI Symposium

Precision Therapeutics, will present pancreatic cancer data based on Precision's ChemoFx in-vitro chemosensitivity test at the 2011 American Society of Clinical Oncology GI Symposium, January 20-22 in San Francisco, California.

20 Jan 2011

4SC initiates dosing in resminostat Phase I/II SHORE study for KRAS-mutant colorectal cancer

4SC AG, a drug discovery and development company, today announced that the first patient has been dosed in the Phase I/II SHORE study with the oral pan-histone deacetylase (HDAC) inhibitor resminostat as a second-line treatment for patients with advanced and metastatic colorectal KRAS-mutant cancer.

20 Jan 2011

Exciton, ULURU sign agreement to develop and market Altrazeal exSALT product

ULURU Inc. announced today that it has signed a Binding Letter of Intent with Exciton Technologies Inc. to develop and market a product that will combine Altrazeal® with Exciton's proprietary exSALT™ Antimicrobial Technology.

20 Jan 2011

Apricus Bio's MycoVa demonstrates 'non-inferiority' for treatment of onychomycosis compared to Loceryl

Apricus Biosciences, Inc. today announced that an additional analysis conducted on behalf of the Company has shown that MycoVa™ has successfully demonstrated 'non-inferiority' for the treatment of onychomycosis (commonly referred to as nail fungus), compared to the current standard of care in Europe for topical therapy, Loceryl®.

20 Jan 2011

GSK and Prosensa commence GSK2402968 Phase III study in DMD

GlaxoSmithKline and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968, in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.

20 Jan 2011

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Targacept, Inc. today announced positive top-line results from a Phase 2 clinical proof of concept trial to assess TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia.

20 Jan 2011

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Pluristem Therapeutics, Inc. today announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company's planned clinical development program for PLX-PAD.

19 Jan 2011

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today highlighted a further analysis of the large randomized Phase II OPUS study demonstrating an association between early tumor shrinkage and long-term median overall survival (OS) of more than 2 years for patients with KRAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux® (cetuximab) plus FOLFOX standard chemotherapy.

19 Jan 2011

Convalescent plasma therapy may reduce mortality rate in patients with H1N1 infection: Study

A study published in the February 15 issue of Clinical Infectious Diseases suggests that convalescent plasma may reduce the death rate in patients severely ill with this type of influenza.

19 Jan 2011

Efficacy News and Research

EDAP announces placement of first Sonolith i-sys electroconductive lithotripter in South Africa

Major breakthrough: Genome-based medicine for treatment of alcoholism

Health Canada approves Labopharm's OLEPTRO for treatment of Major Depressive Disorder

Positive results from nimotuzumab Phase II study for gastric cancer

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

ISCT launches commercial development focus group addressing Cell Therapies for Peripheral Vascular Disease

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

UMB enters license agreement with Bali BioSciences for new strategy to combat sepsis, HIV/AIDS

Precision Therapeutics to present pancreatic cancer data at 2011 ASCO GI Symposium

4SC initiates dosing in resminostat Phase I/II SHORE study for KRAS-mutant colorectal cancer

Exciton, ULURU sign agreement to develop and market Altrazeal exSALT product

Apricus Bio's MycoVa demonstrates 'non-inferiority' for treatment of onychomycosis compared to Loceryl

GSK and Prosensa commence GSK2402968 Phase III study in DMD

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Convalescent plasma therapy may reduce mortality rate in patients with H1N1 infection: Study

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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