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Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

22 Feb 2010

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated a Phase IIb trial in adult lung transplant patients with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. RSV infection in lung transplant patients represents an important unmet medical need; the condition is associated with significant morbidity, including the development of acute lung transplant rejection in 10% to 20% of infected patients.

22 Feb 2010

Cappella promotes serial IVUS analysis & Sideguard 3.25 device at Rome JIM

Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, promoted their serial IVUS analysis & Sideguard® 3.25 device during the Joint Interventional Meeting (JIM) in Rome. Gary S. Mintz, MD, Cardiovascular Research Foundation, New York, USA presented "Positive Vessel Remodeling Using Sideguard in Coronary Bifurcations" during the New Technologies 1 Symposium.

20 Feb 2010

Nuvo Research reports net income in fourth-quarter, driven by FDA approval of Pennsaid

Nuvo Research Inc., a Canadian drug development company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced its financial and operational results for the year and the fourth quarter ended December 31, 2009.

19 Feb 2010

United Therapeutics announces withdrawal of Tyvaso European MAA for treatment of PAH

United Therapeutics Corporation announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the European Union.

19 Feb 2010

SRI International establishes new Neurodegenerative Diseases Research Program

SRI International, an independent nonprofit research and development institute, announced today that a new Neurodegenerative Diseases Research Program has been established within its Center for Health Sciences. This new SRI group of neuroscientists and researchers working at the cutting edge of science brings $6.2 million of funding from the National Institutes of Health (NIH), including the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Environmental Health Sciences (NIEHS), and National Institute of General Medical Sciences (NIGMS).

19 Feb 2010

Echo Therapeutics makes significant advance in designing Symphony tCGM device

Echo Therapeutics, Inc., a company developing the needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, announced today that the Company has made a significant advance in the product design of its Symphony tCGM device and that it has developed its next generation electronic component package.

19 Feb 2010

UCSF, Genentech partner to discover and develop drug candidates for neurodegenerative diseases

The University of California, San Francisco has signed a partnership agreement with Genentech, Inc., a wholly owned member of the Roche Group, to discover and develop drug candidates for neurodegenerative diseases.

19 Feb 2010

The Hamner Institutes signs formal Memorandum of Understanding with Oslo Cancer Cluster

The Hamner Institutes at Research Triangle Park has signed a formal Memorandum of Understanding with the Oslo Cancer Cluster in Oslo, Norway, one of the leading cancer clusters in Europe. The goal of the collaboration is to strengthen The Hamner's Global BioScience Gateway for Translational Research and Business Development, which began with partnerships in China.

19 Feb 2010

Asthma: LABAs should not be used alone

The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

19 Feb 2010

ARYx Therapeutics retains Cowen's services to optimize late-stage asset value

ARYx Therapeutics Inc., a biopharmaceutical company, today announced that it has retained Cowen and Company to explore strategic options for ARYx.

19 Feb 2010

Fourth-quarter and fiscal year 2009 results announced by DJO Incorporated

DJO Incorporated, a global provider of medical device solutions for musculoskeletal health, vascular health and pain management, today announced financial results for its operating subsidiary, DJO Finance LLC (“DJOFL”), for the fourth quarter and fiscal year ended December 31, 2009. ReAble Therapeutics, Inc. (“ReAble”) acquired DJO Incorporated (“DJO Opco”) in a transaction completed on November 20, 2007 (the “DJO Merger”).

18 Feb 2010

West Pharmaceutical Services reports 19.9% growth in consolidated fourth-quarter sales

West Pharmaceutical Services, Inc. today announced its results for the fourth quarter and full year of 2009.

18 Feb 2010

PK/PD data demonstrates clear relationship between TBR-652 plasma concentrations and antiviral activity

Pharmacokinetic/pharmacodynamic (PK/PD) data for TBR-652, which is being developed by Tobira Therapeutics for the treatment of HIV infection, show a strong relationship between drug exposure and viral suppression with this next-generation CCR5 receptor antagonist. These data were presented here today at the 17th Conference on Retroviruses and Opportunistic Infections (CROI).

18 Feb 2010

Norwegian government task force suggests formation of single company to commercialise biomaterial assets

Having studied the ethical, judicial and political arguments, the Norwegian government task force has suggested that a single nationwide company should be formed to commercialise biomaterials assets from the country’s various sources. The task force has also recommended HUNT Biosciences be a model for the national company.

18 Feb 2010

Phase 3b ODIN study of once-daily PREZISTA in HIV-1 adults presented at CROI 2010

In a new study of treatment-experienced HIV-1-infected adults with no PREZISTA® (darunavir) resistance-associated mutations (RAMs), 72 percent of patients in the PREZISTA/ritonavir (r) (800/100 mg) once-daily arm achieved undetectable viral loads (<50 copies/mL) compared with 71 percent of patients in the PREZISTA/r (600/100 mg) twice-daily arm. The study met its primary objective of non-inferiority. These data from the Phase 3b ODIN study were presented today at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco.

18 Feb 2010

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

BioMimetic Therapeutics, Inc. today announced it has submitted the third and final module of its Premarket Approval (PMA) application for marketing of Augment™ Bone Graft in the U.S. This final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA. The Company previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June of 2009.

18 Feb 2010

BrainStorm Cell Therapeutics secures funds for ALS clinical trials

BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, is pleased to announce that it has entered into agreements with three investors with each investing $500,000 for a total of investment of $1.5 million into BrainStorm.

18 Feb 2010

Roche Molecular Systems, Merck Sharp & Dohme announce cancer therapeutics collaboration

Roche Molecular Systems, Inc. announced today a research collaboration with Merck Sharp & Dohme Corp. (a subsidiary of Merck & Co., Inc.) providing Merck access to Roche's developmental microarray-based AmpliChip p53 Test, which is designed to detect mutations in the tumor suppressor gene p53. By identifying cancers that harbor a dysfunctional p53 gene, the companies aim to achieve better treatment outcomes in cancer patients by determining which patients are most likely to respond to certain investigational therapeutic candidates.

18 Feb 2010

Genzyme announces fourth-quarter and full-year 2009 financial results

Genzyme Corp., a diversified, global biotechnology company, today announced fourth-quarter and full year 2009 financial results and provided 2010 guidance that reflects growth across its businesses and a focus on strengthening core areas of the company.

18 Feb 2010

Therapeutics News and Research

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Cappella promotes serial IVUS analysis & Sideguard 3.25 device at Rome JIM

Nuvo Research reports net income in fourth-quarter, driven by FDA approval of Pennsaid

United Therapeutics announces withdrawal of Tyvaso European MAA for treatment of PAH

SRI International establishes new Neurodegenerative Diseases Research Program

Echo Therapeutics makes significant advance in designing Symphony tCGM device

UCSF, Genentech partner to discover and develop drug candidates for neurodegenerative diseases

The Hamner Institutes signs formal Memorandum of Understanding with Oslo Cancer Cluster

Asthma: LABAs should not be used alone

ARYx Therapeutics retains Cowen's services to optimize late-stage asset value

Fourth-quarter and fiscal year 2009 results announced by DJO Incorporated

West Pharmaceutical Services reports 19.9% growth in consolidated fourth-quarter sales

PK/PD data demonstrates clear relationship between TBR-652 plasma concentrations and antiviral activity

Norwegian government task force suggests formation of single company to commercialise biomaterial assets

Phase 3b ODIN study of once-daily PREZISTA in HIV-1 adults presented at CROI 2010

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

BrainStorm Cell Therapeutics secures funds for ALS clinical trials

Roche Molecular Systems, Merck Sharp & Dohme announce cancer therapeutics collaboration

Genzyme announces fourth-quarter and full-year 2009 financial results

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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