Efficacy News and Research

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DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

The Gamida Cell-Teva Joint Venture (JV) announced today that the Data Monitoring Committee (DMC) has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study.

10 Feb 2010

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc.

10 Feb 2010

People living with IBD are at high risk of blood clots

People living with Inflammatory Bowel Disease (IBD) are known to be at high risk of blood clots when admitted to hospital during a flare-up of their disease but now new research by scientists at The University of Nottingham has shown that those who are not admitted to hospital during flare-ups are also at risk.

10 Feb 2010

Patients treated with Biodesign Inguinal Hernia Graft experience less postoperative pain

Results from a clinical study led by Luca Ansaloni, M.D., showed that Cook Medical’s Biodesign Inguinal Hernia Graft causes less postoperative pain and discomfort while creating a repair as durable as synthetic mesh when used in Lichtenstein’s hernioplasty procedures.

10 Feb 2010

New research suggests closantel drug may be useful in combating river blindness

Scientists at The Scripps Research Institute have discovered a potential new use for the drug closantel, currently the standard treatment for sheep and cattle infected with liver fluke. The new research suggests that the drug may be useful in combating river blindness, a tropical disease that is the world's second leading infectious cause of blindness for humans.

10 Feb 2010

Cerus enters into collaborative agreement with EFS for development of INTERCEPT Blood System

Cerus Corporation announced today that it has entered into a collaborative agreement with France's national transfusion service, the Etablissement Français du Sang (EFS), for the development of the company's INTERCEPT Blood System for red blood cells.

10 Feb 2010

PolyMedix provides overview of its 2010 clinical milestones

PolyMedix, Inc. (www.polymedix.com), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, provided an overview of its 2010 clinical milestones in a presentation by President & C.E.O., Nicholas Landekic at the 2010 BIO CEO & Investor Conference.

10 Feb 2010

Elan announces fourth-quarter and full-year financial results ended December 31, 2009

Elan Corporation, plc today reported its fourth quarter and full-year 2009 financial results and provides financial guidance for 2010.

10 Feb 2010

Study shows lactobacillus is effective in improving H. pylori-infected diseases

Helicobacter pylori (H. pylori) are considered to be the most important etiological agents of chronic gastritis. The eradication of H. pyloridepends on the combination of antibiotics and acid suppression drugs.

10 Feb 2010

GA²LEN and EAACI warn: Older antihistamines in OTC allergy medications may be hazardous

A joint GA²LEN /EAACI report to be published in "Allergy" and available online on 8 February reviews new data on the treatment of allergies with older antihistamines compared with newer, second-generation H1-antihistamines. The research was funded by GA²LEN, an EU-funded Network of Excellence.

10 Feb 2010

Chamomile extract therapy effective for generalized anxiety disorder

Feeling stressed? Try chamomile! This 'traditional' remedy has been around for years, but how much truth is there behind this old wives' tale?

10 Feb 2010

TI commences Phase IIa clinical trial for its lead molecule in CDH

Trigemina, Inc. (TI), a Mountain View based startup, has begun a Phase IIa clinical trial for its lead molecule in Chronic Daily Headache (CDH) in collaboration with Dr. Egilius Spierings at MedVadis Research Corporation located outside of Boston.

10 Feb 2010

Advaxi to receive fund from CRUK for clinical trial of ADXS11-001

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is pleased to announce that Cancer Research UK (CRUK), the UK philanthropy dedicated to cancer research, has agreed to fund the cost of a clinical trial to investigate the use of ADXS11-001, Advaxis’ lead human papilloma virus (HPV)-directed vaccine candidate, for the treatment of head and neck cancer.

10 Feb 2010

Biogen Idec reports 2009 fourth quarter and full year earnings

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its full year and fourth quarter 2009 results.

9 Feb 2010

Third-quarter fiscal 2010 results announced by Clinical Data

Clinical Data, Inc. (NASDAQ: CLDA) today announced the Company’s operational and financial results for its third fiscal quarter ended December 31, 2009, confirming its plans to submit a new drug application (NDA) for vilazodone for the treatment of depression this quarter.

9 Feb 2010

Study validates Transgenomic's COLD-PCR technology for colorectal tumor-associated KRAS mutation detection

Transgenomic, Inc. announced today that it has completed a preliminary study with a leading pharmaceutical company that validates the use of its licensed COLD-PCR technology to detect colorectal tumor-associated KRAS mutations that determine efficacy of recently developed therapies. These were detected in plasma samples in which the mutation levels were too low for detection by standard DNA analysis methodologies such as Sanger sequencing.

9 Feb 2010

Thrombogenics announces publication of positive microplasmin Phase II trial results

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that the positive microplasmin Phase II trial results, evaluating the product's efficacy and safety in patients who require vitrectomy, have been published in the prestigious American Academy of Ophthalmology's Journal, Ophthalmology, the leading journal for the vitreoretinal community.

9 Feb 2010

U.S. PSA screening efficacy lower than in ERSPC-Rotterdam due to lower testing sensitivity

Fewer prostate cancers were detected by prostate-specific antigen (PSA) screening in the U.S. than in a European randomized trial because of lower screening sensitivity, according to a new brief communication published online February 8 in the Journal of the National Cancer Institute.

9 Feb 2010

Cell Therapeutics' pixantrone NDA: FDA postpones ODAC meeting due to severe weather conditions

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). The FDA indicated that it intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel.

9 Feb 2010

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

Amgen today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints.

9 Feb 2010

Efficacy News and Research

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

Biovail and Alexza Pharmaceuticals sign collaboration and license agreement for anti-agitation drug

People living with IBD are at high risk of blood clots

Patients treated with Biodesign Inguinal Hernia Graft experience less postoperative pain

New research suggests closantel drug may be useful in combating river blindness

Cerus enters into collaborative agreement with EFS for development of INTERCEPT Blood System

PolyMedix provides overview of its 2010 clinical milestones

Elan announces fourth-quarter and full-year financial results ended December 31, 2009

Study shows lactobacillus is effective in improving H. pylori-infected diseases

GA²LEN and EAACI warn: Older antihistamines in OTC allergy medications may be hazardous

Chamomile extract therapy effective for generalized anxiety disorder

TI commences Phase IIa clinical trial for its lead molecule in CDH

Advaxi to receive fund from CRUK for clinical trial of ADXS11-001

Biogen Idec reports 2009 fourth quarter and full year earnings

Third-quarter fiscal 2010 results announced by Clinical Data

Study validates Transgenomic's COLD-PCR technology for colorectal tumor-associated KRAS mutation detection

Thrombogenics announces publication of positive microplasmin Phase II trial results

U.S. PSA screening efficacy lower than in ERSPC-Rotterdam due to lower testing sensitivity

Cell Therapeutics' pixantrone NDA: FDA postpones ODAC meeting due to severe weather conditions

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

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