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Forest Laboratories' ceftaroline fosamil receives FDA Advisory Committee approval for CABP and cSSSI

Forest Laboratories, Inc. announced that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted 21 - 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 - 0 in favor of approval for complicated skin and skin structure infections (cSSSI).

8 Sep 2010

Bristol-Myers Squibb signs definitive agreement to acquire ZymoGenetics

Bristol-Myers Squibb Company and ZymoGenetics, Inc. announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash.

8 Sep 2010

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 2a clinical study of PRM-151 to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery. There currently are no approved drugs for preventing post-surgical scarring in glaucoma, and there are no approved anti-fibrotic drug therapies in the U.S. or Europe for any fibrotic disease.

7 Sep 2010

Bruker launches Icon desktop MRI systems at 2010 World Molecular Imaging Congress

At the 2010 World Molecular Imaging Congress in Kyoto, Bruker Corporation today announces the introduction of the Icon™, a new easy-to-use 1 Tesla desktop MRI scanner that combines simplicity with compact dimensions, in order to bring preclinical magnetic resonance imaging (MRI) within reach for a broader range of molecular imaging laboratories.

7 Sep 2010

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold.

7 Sep 2010

DSM, PolyTherics enter agreement for HiPEG IFN alpha-2a product development

DSM BioSolutions, DSM's microbial fermentation CMO business unit and PolyTherics Limited an innovator in precision engineering of proteins, today announced that they have entered into an agreement for the process development and manufacture of PolyTherics' lead biobetter product, HiPEG IFN alpha-2a.

7 Sep 2010

Challenges Chief Medical Officers face in clinical trial operations

“One of the major issues that Chief Medical Officers (CMO) encounter in their day to day practice is the variety of countries that they deal with and the different regulatory issues that they need to solve.”

4 Sep 2010

Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

There is yet no straightforward way to determine the optimal dose level and treatment schedules for high-dose radiation therapies such as stereotactic radiation therapy, used to treat brain and lung cancer, or for high-dose brachytherapy for prostate and other cancers.Radiation oncologists at the Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute may have solved the problem by developing a new mathematical model that encompasses all dose levels.

3 Sep 2010

Millennium publishes article on MLN4924 pathway mechanism in lymphoma

Millennium, The Takeda Oncology Company today announced the publication of an article in the journal Blood describing the novel mechanism of action of MLN4924 through targeted pathway modulation in diffuse large B-cell lymphoma (DLBCL).

3 Sep 2010

Study shows molecular imaging benefits treatment planning for wide spectrum of cancers

A series of studies published in the September Journal of Nuclear Medicine (JNM) show that molecular imaging plays a critical role in the evaluation and treatment planning for a broad spectrum of cancers, including thyroid cancer and lymphoma.

3 Sep 2010

Celsion receives SBIR grant to develop heat sensitive liposomal technology for cancer treatment

Celsion Corporation, a biotechnology drug development company, announced today that it has been awarded a competitive Phase I Small Business Innovation and Research (SBIR) grant from the National Institutes of Health (NIH), to support the proposal, "New Thermal Sensitive Carboplatin Liposomes for Cancer".

3 Sep 2010

CaPre drug candidate shows promising result on CRP level reduction

Acasti Pharma Inc., a subsidiary of Neptune Technologies & Bioressources Inc. reports significant results on the effects of its anti-dyslipidemic investigational drug candidate CaPre on C-reactive protein (CRP) levels, a biomarker of CardioVascular Disease risk (CVD) and associated with diabetes and obesity.

3 Sep 2010

Lytix Biopharma granted Hungarian approval for Lytixar Phase IIa clinical trial in Gram positive skin infections

The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval in Hungary to commence a Phase IIa clinical trial with Lytixar (LTX-109) treatment of skin infections caused by Gram positive bacteria.

2 Sep 2010

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has signed a contract valued at up to $153 million over five years with the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, to develop CLT-008, a cellular therapy for the treatment of Acute Radiation Syndrome (ARS).

2 Sep 2010

Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

Nabi Biopharmaceuticals announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.

2 Sep 2010

Pfizer enters agreement to acquire FoldRx Pharmaceuticals

Pfizer Inc. and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical development company, today announced that they have entered into an agreement under which Pfizer will acquire FoldRx.

2 Sep 2010

Martek Biosciences 2010 third quarter revenue increases 51% to $117.2 million

Martek Biosciences Corporation today announced its financial results for the third quarter of fiscal 2010.

2 Sep 2010

Naurex announces GLYX-13 molecule recognized in “Top 10 to Watch" list for depression treatment

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, today reported that its clinical stage candidate for the treatment of depression, GLYX-13, and its second-generation NRX-1050 series have been selected for inclusion on Windhover's list of the "Top 10 Most Interesting Neuroscience Projects to Watch."

31 Aug 2010

NewYork-Presbyterian /Columbia sets up new Myelodysplastic Syndromes Center

NewYork-Presbyterian Hospital/Columbia University Medical Center has established a new center devoted to research and treatment of pre-leukemia blood disorders. Known as the Myelodysplastic Syndromes Center, it is one of the largest programs of its kind in the nation.

31 Aug 2010

TPP and University of Edinburgh collaborate on development of novel pre-clinical intellectual property

TPP Global Development Ltd (TPP) announced an agreement with the University of Edinburgh to collaborate on the development of novel pre-clinical intellectual property originated within the University.

31 Aug 2010

Preclinical News and Research

Forest Laboratories' ceftaroline fosamil receives FDA Advisory Committee approval for CABP and cSSSI

Bristol-Myers Squibb signs definitive agreement to acquire ZymoGenetics

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

Bruker launches Icon desktop MRI systems at 2010 World Molecular Imaging Congress

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

DSM, PolyTherics enter agreement for HiPEG IFN alpha-2a product development

Challenges Chief Medical Officers face in clinical trial operations

Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

Millennium publishes article on MLN4924 pathway mechanism in lymphoma

Study shows molecular imaging benefits treatment planning for wide spectrum of cancers

Celsion receives SBIR grant to develop heat sensitive liposomal technology for cancer treatment

CaPre drug candidate shows promising result on CRP level reduction

Lytix Biopharma granted Hungarian approval for Lytixar Phase IIa clinical trial in Gram positive skin infections

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

Pfizer enters agreement to acquire FoldRx Pharmaceuticals

Martek Biosciences 2010 third quarter revenue increases 51% to $117.2 million

Naurex announces GLYX-13 molecule recognized in “Top 10 to Watch" list for depression treatment

NewYork-Presbyterian /Columbia sets up new Myelodysplastic Syndromes Center

TPP and University of Edinburgh collaborate on development of novel pre-clinical intellectual property

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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