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MAA for naproxcinod submitted to EMEA through centralized procedure

NicOx S.A. today announced that a Marketing Authorization Application (MAA) for naproxcinod has been submitted to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA).

22 Dec 2009

Grant of $1 million awarded to develop new treatments for dyskinesia

The Michael J. Fox Foundation for Parkinson's Research has awarded $1 million for a clinical study aiming to make a critical step toward the development of new treatments for dyskinesia, the excessive and uncontrollable movements that are a complication of long-term dopamine replacement therapy in patients with Parkinson's disease.

22 Dec 2009

LEO Pharma announces positive results for two Phase III AK clinical trials

LEO Pharma today announced positive results for the company’s two Phase III actinic (solar) keratosis (AK) clinical trials using PEP005 (ingenol mebutate) Gel for the treatment of lesions on head treatment areas, which include the face and scalp.

22 Dec 2009

Effectiveness of VSEL stem cells in regenerative medicine demonstrated at the ASH meeting

NeoStem, Inc. (NYSE Amex: NBS), which is a leading provider of pre-disease adult stem cell collection, processing and long-term storage services, and holds the exclusive, worldwide license to VSEL(TM) technology that uses very small embryonic-like stem cells isolated from peripheral blood, announced today that five posters and two oral presentations at the prestigious American Society of Hematology (ASH) Annual Meeting in New Orleans in early December demonstrated the basic cellular mechanisms of very small embryonic-like stem cells.

21 Dec 2009

CSC completes a Series B financing round

California Stem Cell, Inc. (CSC), a leading stem cell company, announced that it has completed a Series B financing round with private investors. The financing will enable the company to support the advancement of its therapeutic products to human clinical trials, as well as the generation and distribution of its tools to aid in stem cell research and drug discovery.

21 Dec 2009

TessArae's RM-Flu test granted FDA EUA

TessArae, LLC, a privately held company, and Affymetrix Inc., (NASDAQ:AFFX) today announced that the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to TessArae for its TessArray® Resequencing Influenza A Microarray Detection Panel for the Detection of the 2009 H1N1 Influenza A Virus (TessArray RM-Flu test) for the duration of the declaration of emergency unless revoked earlier. The declaration of emergency will expire on April 26, 2010, unless terminated earlier or renewed.

21 Dec 2009

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

CPEX Pharmaceuticals, Inc. today announced that the ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal insulin candidate, has now completed enrollment. The study was initiated in February of this year and randomized 94 subjects. Results are expected at the end of the first quarter or beginning of the second quarter of 2010.

21 Dec 2009

Organogenesis files a PMA with the FDA for its CelTx living cell-based technology

Organogenesis, Inc. announced today that it has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its CelTx(TM), a living cellular construct for oral soft tissue regeneration. If approved, CelTx will be the first, living cell-based technology that is FDA-approved for use in the dental market.

21 Dec 2009

Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), for the prevention of acute radiation enteritis.

21 Dec 2009

Embryo biopsy does not adversely affect health of newborn singleton PGD/PGS children

The largest and longest running study of children born after preimplantation genetic diagnosis and screening has shown that embryo biopsy does not adversely affect the health of babies born as the result of a subsequent singleton pregnancy.

21 Dec 2009

Taro Pharmaceutical Industries initiates its T2007 non-sedating barbiturate compound Phase I clinical trials

Taro Pharmaceutical Industries Ltd. announced that it has begun Phase I clinical trials in Canada with T2007, the second in the Company’s class of proprietary non-sedating barbiturate compounds to be approved for studies in humans.

18 Dec 2009

Recent releases in Global Health

A Scientific American article examines recent efforts to tackle neglected tropical diseases (NTDs). The author writes "NTDs have plagued humankind for thousands of years. … What is new, however, is that donors, drugmakers, health ministries in low- and middle-income countries, the World Health Organization (WHO), and public-private partnerships are linking their efforts to combat the NTDs in a more coordinated and systematic way."

18 Dec 2009

John Theurer Cancer Center presents over 20 research updates and trial results at the 2009 ASH meeting

Doctors and researchers from the John Theurer Cancer Center at Hackensack University Medical Center recently presented research updates and clinical trial results of more than 20 innovative studies at the American Society of Hematology (ASH) annual meeting from December 5-8, 2009.

18 Dec 2009

U.S. health officials announce shift in focus of prep trial in Botswana

U.S. health officials on Thursday announced they will shift the focus of a clinical trial in Botswana aimed at testing pre-exposure prophylaxis (PrEP) - the strategy that "a daily low dose of the drugs, which interfere with the ability of the virus to replicate, could also lower the risk of infection" - after researchers discovered they would be unable to determine the efficacy of Truvada, the medicine used in the trial, Reuters reports.

18 Dec 2009

Flamel Technologies initiates IFN-alpha-2b XL Phase 2a clinical trial for HCV

Flamel Technologies today announced the initiation of a Phase 2a clinical trial of Flamel’s Interferon alpha-2b XL (IFN-alpha-2b XL), which is based on Flamel’s Medusa® platform for controlled release of biologics. IFN-alpha-2b XL is being developed as a controlled release of unmodified interferon alpha-2b for the treatment of chronic hepatitis C virus (HCV).

18 Dec 2009

Cost of Avastin a deterrent for non-small-cell lung cancer treatment

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the cost of Roche/Chugai's Avastin, followed by concerns about its efficacy and side-effect profile, are cited most frequently by surveyed oncologists as the factors preventing their use of Avastin for non-small-cell lung cancer treatment in Germany, France, Italy, Spain and the United Kingdom.

18 Dec 2009

Joe Chimera, the 25th person to receive MEP Certification from PHII

The Population Health Impact Institute (PHII) is pleased to announce that Joe Chimera, Ph.D., is the 25th person to receive the Methods Evaluation Process (MEP) Certification.

18 Dec 2009

Vion Pharmaceuticals files for bankruptcy

VION PHARMACEUTICALS, INC., a pharmaceutical company focused on the development of novel cancer therapeutics, announced that it had voluntarily filed for bankruptcy under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware.

18 Dec 2009

FDA advisory committee votes against approval of Tarceva for lung cancer treatment

Yesterday, an advisory committee to the Food and Drug Administration voted against the approval of Tarceva(R) (erlotinib) as maintenance treatment for advanced lung cancer patients.

18 Dec 2009

Treprostinil drug reduces breathlessness in PAH patients, says study

Patients with a rare, deadly disease that mostly affects young women felt a dramatic reduction in breathlessness using an approved drug, according to study results published online today in The Journal of Heart and Lung Transplantation.

18 Dec 2009