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RXi’s RXI-109 IND receives FDA clearance to proceed into clinical trials

RXi Pharmaceuticals Corporation today announced that it has received clearance for its investigational new drug application (IND) from the U.S. Food and Drug Administration (FDA) to initiate clinical trials with RXI-109, a self-delivering RNAi compound that selectively targets Connective Tissue Growth Factor.

1 Jun 2012

FDA approves RBI’s AppliGel-G for human testing

Royer Biomedical, Inc. (RBI) received FDA approval to proceed with Human Testing of AppliGel-G (Gentamicin) in management of Diabetic Foot Ulcers.

1 Jun 2012

Taiho to initiate TAS-102 Phase III trial in colorectal cancer

Taiho Pharmaceutical Co., Ltd. announced on May 31 that a global Phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 will start in June this year.

31 May 2012

Nouveau Life Pharmaceuticals launches new supplement for women with FSD

Nouveau Life Pharmaceuticals, Inc. announced today the release of the first product in the Company's New Life Naturals line of quality, all-natural dietary supplements.

31 May 2012

Nepstar first quarter revenue increases 1.3% to RMB625.8M

China Nepstar Chain Drugstore Ltd., the largest retail drugstore chain in China based on the number of directly operated stores, today announced its unaudited financial results for the first quarter ended March 31, 2012.

31 May 2012

Pharmspective releases ‘Molecular Diagnostics Insights in Oncology’

Pharmspective, LLC today announced the release of its second syndicated report – Molecular Diagnostics Insights in Oncology. This new extensive survey of over 400 oncologists characterizes the emerging molecular diagnostics landscape and the role and influence of specific assays in clinical management and therapy selection.

31 May 2012

AAPS honors Morphotek with 2012 Excellence in Ligand Binding Assays Award

Morphotek, Inc., a subsidiary of Eisai Inc., announced today that The American Association of Pharmaceutical Scientists (AAPS) has awarded its 2012 Excellence in Ligand Binding Assays Award to the Bioanalytical Development group from Morphotek for their abstract, "Development and Validation of a Pharmacokinetic Assay on the Gyrolab Platform for Use in Phase II/III Clinical Studies."

31 May 2012

State roundup: Minn. defends Medicaid billing; Cigna, N.H. Group form joint venture; Health coupons in Mass.

Top Minnesota health officials pushed back Tuesday against a congressional committee probing allegations that the state overbilled federal taxpayers for Medicaid services to cover losses from in other state-run public health programs. In a letter to the House Oversight and Government Reform Committee, Minnesota Human Services Commissioner Lucinda Jesson defended reforms implemented under DFL Gov. Mark Dayton, saying "our focus has been on changing course rather than investigating the past."

31 May 2012

Top-line results from Alnylam’s ALN-RSV01 Phase IIb trial on RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today top-line results from a Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.

31 May 2012

Study shows how tafamidis drug works against amyloid disease

Scientists from The Scripps Research Institute and Pfizer Inc. have published a new study showing how a new drug called tafamidis (Vyndaqel) works.

31 May 2012

China Shenghuo first quarter total revenue increases 20.5% to $11.4M

China Shenghuo Pharmaceutical Holdings, Inc., today reported financial results for the first quarter ended March 31, 2012.

31 May 2012

Corrected interim data from Vertex VX-809, KALYDECO combination Phase 2 study for CF

Vertex Pharmaceuticals Incorporated announced today a correction to the previously reported responder analysis, as well as additional data from, the recent interim analysis of an ongoing Phase 2 study of VX-809 and KALYDECO that showed significant improvements in lung function among adults with cystic fibrosis who have two copies of the most common mutation in the cystic fibrosis transmembrane conductance regulator gene, F508del.

30 May 2012

Law aims to illuminate financial links between doctors and pharmaceutical companies

A Colorado School of Public Health researcher has found that laws designed to illuminate financial links between doctors and pharmaceutical companies have little or no effect on what drugs physicians prescribe.

30 May 2012

CytRx INNO-206 doxorubicin conjugate shows anti-multiple myeloma effects

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that in animal and in vitro studies, its tumor-targeting doxorubicin conjugate INNO-206 showed anti-multiple myeloma effects and enhanced the anti-tumor effects of bortezomib, which is approved for the treatment of relapsed multiple myeloma.

30 May 2012

New treatment for sickle cell disease developed by Emmaus Medical receives positive opinion from EMA

Emmaus Medical, Inc., a pharmaceutical company developing a new treatment for sickle cell disease, and subsidiary of Emmaus Life Sciences, Inc., announced today that its investigational L-glutamine treatment for sickle cell disease has received a positive opinion recommending orphan medicinal product designation by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). The designation allows Emmaus ten years of marketing exclusivity in EU member countries after the product obtains marketing authorization, as well as streamlined regulatory review processes and registration and other fee reductions.

30 May 2012

Biogen Idec, MS community partner to celebrate Fourth Annual World MS Day

Today, Biogen Idec will join with the multiple sclerosis (MS) community around the world to celebrate the Fourth Annual World MS Day by hosting diverse educational activities across the globe.

30 May 2012

Endo, Watson reach agreement to resolve two LIDODERM patent infringement lawsuits

Endo announced today that it has reached an agreement with Watson Pharmaceuticals (Watson) resolving two patent infringement lawsuits related to LIDODERM.

30 May 2012

PRS launches Global Regulatory Intelligence Database

Pharmaceutical Regulatory Services, Inc., a global provider of regulatory and pharmacovigilance support to the pharmaceutical, biotechnology and medical device industries, is pleased to announce the launch of GRID - Global Regulatory Intelligence Database.

30 May 2012

Positive results from RedHill’s RHB-103 bioequivalence trial on acute migraine

RedHill Biopharma Ltd., an emerging Israeli biopharmaceutical company focusing primarily on development of late clinical-stage (Phase II/III), patent protected, new formulations and combinations of existing drugs, announces positive results in a pivotal bioequivalence clinical trial with RHB-103, an oral thin-film formulation of Rizatriptan for the treatment of acute migraine.

30 May 2012

NAC may be an effective therapy for some features of autism

A specific antioxidant supplement may be an effective therapy for some features of autism, according to a pilot trial from the Stanford University School of Medicine and Lucile Packard Children's Hospital that involved 31 children with the disorder.

30 May 2012