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FDA issues CRL for AZ-004 NDA application

Alexza Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato loxapine), submitted as Adusuve Staccato (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

11 Oct 2010

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine.

11 Oct 2010

Weight loss pill off shelves due to heart attack risk

Final verdict on a popular weight loss drug Reductil is to be delivered today. It is being debated whether the pill should be taken off the shelves in Australia and New Zealand. The drug Sibutramine sold as Reductil is linked to increased risk of heart attacks.

10 Oct 2010

Clinical study data on Natural S-equol supplement presented at NAMS Annual Meeting

Four clinical studies that add to the evidence about the use of a new nutritional supplement containing the whole soy germ-based ingredient Natural S-equol to improve health were presented at the North American Menopause Society (NAMS) Annual Meeting.

8 Oct 2010

Abiraterone Phase III clinical data to be presented at ESMO meeting

Attendees at next week's European Society of Medical Oncology (ESMO) meeting in Milan will be presented with top-line Phase III Clinical Trials data on Abiraterone in the treatment of castration-resistant prostate cancer.

8 Oct 2010

Pfizer announces tasocitinib Phase 2 data for plaque psoriasis

Pfizer Inc. today announced that data from a Phase 2 efficacy and safety study of tasocitinib the company's investigational oral JAK inhibitor, met its primary endpoint of a statistically significant greater proportion of patients achieving at least a 75 percent reduction from baseline in PASI (Psoriasis Area and Severity Index) at week 12 in individuals with chronic moderate to severe plaque psoriasis.

8 Oct 2010

IV ibuprofen effective in reducing fever in hospitalized patients

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.

8 Oct 2010

Firm sees drugs sales rising 5 to 7 percent next year, other drug industry news

The Associated Press reports that global prescription drug sales should rise 5 percent to 7 percent next year reaching at least $880 billion, fueled by new drugs and rising sales in developing countries, according to drug data firm IMS Health.

8 Oct 2010

Innovative trial designs may improve efficiency of clinical trials

Clinical trials in which participants are randomly assigned to different treatments by design are the cornerstone of clinical research. When conducted correctly, it's widely accepted by the research community that the results are valid and can be trusted.

8 Oct 2010

VentiRx announces VTX-1463 trial results for allergic rhinitis treatment

VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 (TLR8) candidates for the treatment of cancer, respiratory and inflammatory diseases, announced today results from its randomized, placebo controlled clinical trial evaluating VTX-1463 for the treatment of allergic rhinitis.

8 Oct 2010

Phase 3 study of D-tagatose in Type 2 diabetes shows significant reduction in HbA1c levels

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its Phase 3 study of D-tagatose as a monotherapy in Type 2 diabetes showed a statistically significant (p<0.05) reduction in HbA1c levels of 0.4% at 10 months in relatively healthy people with diabetes

8 Oct 2010

Targacept announces top-line results from AZD1446 Phase 2 clinical trial for ADHD

Targacept, Inc. today announced top-line results from a Phase 2 clinical trial of AZD1446 conducted by AstraZeneca in adults with attention deficit/hyperactivity disorder (ADHD).

8 Oct 2010

Soy germ-based nutritional supplement helps to manage menopausal symptoms

A new women-s health, whole soy germ-based nutritional supplement containing Natural S-equol reduced the frequency of moderate to severe hot flashes and reduced muscle and joint pain in the first study of its kind among postmenopausal U.S. women, according to peer-reviewed data presented as a poster presentation at the North American Menopause Society (NAMS) Annual Meeting.

7 Oct 2010

Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

Ferring Pharmaceuticals Inc. today announced publication of one of its pivotal Phase 3 trials of LYSTEDA (tranexamic acid) tablets for cyclic heavy menstrual bleeding in the October issue of the peer-reviewed journal, Obstetrics & Gynecology. The six-month clinical trial demonstrated that LYSTEDA significantly reduced menstrual blood loss from baseline, and improved health-related quality-of-life parameters in women with cyclic HMB while maintaining safety and tolerability.

7 Oct 2010

Raloxifene drug may be useful in treating kidney disease in women: Study

The osteoporosis drug raloxifene may be useful in treating kidney disease in women, suggests a new study led by Michal Melamed, M.D., M.H.S., assistant professor of medicine and epidemiology & population health at the Albert Einstein College of Medicine of Yeshiva University.

7 Oct 2010

Patients with muscular dystrophy mount immune response to dystophin protein prior to gene therapy: Study

A clinical trial designed to replace the genetic defect causing the most common form of muscular dystrophy has uncovered an unexpected aspect of the disease. The trial, based on therapy designed by scientists at the University of North Carolina at Chapel Hill School of Medicine, showed that some patients mount an immune response to the dystrophin protein even before they have received the gene therapy.

7 Oct 2010

Vitamin D supplementation in healthy kids pointless: Study

According to a Cochrane Systematic Review released on October 6th, yesterday vitamin D supplements when given to healthy children with normal vitamin D levels does not improve bone density at the hip, lumbar spine, forearm or in the body as a whole.

6 Oct 2010

Michael J. Fox Foundation for Parkinson's Research announces awards totaling $10.1M

The Michael J. Fox Foundation for Parkinson's Research announced awards totaling approximately $10.1 million for five new clinical studies and 14 pre-clinical therapeutic development projects. The funding includes $2.5 million to drive four new clinical trials under the Clinical Intervention Awards, one of the Foundation's Edmond J. Safra Core Programs for PD Research.

6 Oct 2010

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today positive results in a Phase IIa clinical trial of plecanatide (SP-304) in patients with chronic constipation. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1.0, 3.0 and 9.0 mg gave improved bowel function in patients with chronic constipation.

6 Oct 2010

Placebo News and Research

FDA issues CRL for AZ-004 NDA application

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

Weight loss pill off shelves due to heart attack risk

Clinical study data on Natural S-equol supplement presented at NAMS Annual Meeting

Abiraterone Phase III clinical data to be presented at ESMO meeting

Pfizer announces tasocitinib Phase 2 data for plaque psoriasis

IV ibuprofen effective in reducing fever in hospitalized patients

Firm sees drugs sales rising 5 to 7 percent next year, other drug industry news

Innovative trial designs may improve efficiency of clinical trials

VentiRx announces VTX-1463 trial results for allergic rhinitis treatment

Phase 3 study of D-tagatose in Type 2 diabetes shows significant reduction in HbA1c levels

Targacept announces top-line results from AZD1446 Phase 2 clinical trial for ADHD

Soy germ-based nutritional supplement helps to manage menopausal symptoms

Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

Raloxifene drug may be useful in treating kidney disease in women: Study

Patients with muscular dystrophy mount immune response to dystophin protein prior to gene therapy: Study

Vitamin D supplementation in healthy kids pointless: Study

Michael J. Fox Foundation for Parkinson's Research announces awards totaling $10.1M

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

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