Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

... trial was to assess safety and evaluate the effect of three doses of BA058 on bone formation markers ... the critical anatomic sites with less resorptive effect and less hypercalcemia compared to PTH and its ... by stimulating bone formation with limited effect on bone resorption and less risk of ....

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with ... is that it may change your heart rhythm. This effect is potentially serious. You should talk to your ... a rare, but serious and sometimes permanent side effect reported with INVEGA((R)) SUSTENNA(TM) and ...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

... titration from monotherapy. The antihypertensive effect of Tekturna HCT were largely manifested within 1 week. The maximum antihypertensive effect was generally attained after about 4 weeks of ... In clinical studies, the most common side effect experienced by more patients taking TEKTURNA than ...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

... dose response for niacin-induced flushing, the effect of food on niacin-induced flushing, and the ... ingredients can generate a temporary, unpleasant effect if orally over-consumed, turn dissolved tablets ... would be released, mitigating the euphoric effect of the morphine. The clinical significance of the ...

Spherix Announces Positive Phase 2 Study Results

... g group. Naturlose appears to begin showing an effect on HbA1c within the range of doses selected for ... or an adjunct therapy. In addition, the effect on serum lipoproteins may lead to a role for ... dose of Naturlose capable of causing a beneficial effect on HbA1c, and the safety of such doses. Naturlose ...

Alfacell Provides Shareholder Update

... studies on immune deficient mice to see what effect Onconase would have on human tumors grafted onto ... showed Onconase has a documented synergistic effect in Cisplatin sensitive and resistant NSCLC. We ... on animals that Onconase strongly enhances effect of many types of anticancer drugs. The ...

Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation

... in an oral presentation ( Abstract 157: effect of Linaclotide on IBS-C Symptoms in the First ... McCormick Place, Room E352 Abstract 418: effect of Linaclotide on Quality of Life in Adults with ... Abstract 1273: Time to Onset of Linaclotide effect on the Bowel Habits in Patients with Chronic ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... suspension) demonstrated a significant antitumor effect in patients with metastatic neuroendocrine tumors ... at 18 sites in Germany to evaluate the antitumor effect of Sandostatin LAR in patients with midgut NET. ... approval of Sandostatin LAR did not study effect on tumor size or rate of growth. The most ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... supportive evidence of a pirfenidone treatment effect was observed on a number of measures, including ... significant and clinically meaningful effect on both the primary endpoint of change in percent ... supportive of CAPACITY 2. Further, the treatment effect observed in the CAPACITY studies was generally ...

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

... long-term study was conducted to evaluate the effect of RISPERDAL(R) CONSTA(R) as maintenance therapy ... (NMS) is a rare and potentially fatal side effect reported with RISPERDAL(R) CONSTA(R) and similar ... (TD) is a serious, sometimes permanent side effect reported with RISPERDAL(R) CONSTA(R) and similar ...

Melanoma and Pregnancy: What Every Woman Needs to Know About the Risks, Prognosis

... there has been ongoing controversy concerning the effect of hormones on melanoma," said Dr. Driscoll. ... indicating that hormones did not have a negative effect on melanoma," said Dr. Driscoll. "Having ... two large population-based studies have found no effect on prognosis when melanoma is diagnosed during ...

Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

... of the IMPACT study. "The treatment effect on overall survival was clinically meaningful, robust and consistent across subpopulations, and the effect on long-term survival was particularly ... to the results described above, the treatment effect was consistent across multiple patient subsets ...

Children's Hospital Receives $6.7 Million Grant From Gates Foundation to Study Influenza Vaccine in Pregnant Women in Asia

... field study will help us demonstrate the full effect of the flu vaccination in low-resource areas." ... study will also help researchers understand the effect that vaccinating mothers has on unvaccinated ... implications. "If the flu vaccine has as great an effect in rural settings as in urban ones, the data will ...

New PRO2000 HIV-Prevention Findings Important Milestone on Path Toward Development of Effective Vaginal Microbicide

... BufferGel unfortunately did not show a protective effect against HIV, the trial indicated that PRO2000 was ... product at this efficacy level. While the 30% effect within this trial is not statistically ... highly supportive. Additionally, the protective effect of PRO2000 is corroborated by analysis of various ...

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)

... (NMS) is a rare and potentially fatal side effect reported with paliperidone and similar medicines. ... is that it may change your heart rhythm. This effect is potentially serious, and you should talk to ... (TD) is a serious, sometimes permanent side effect reported with paliperidone and similar ...

New Study First to Confirm Sandostatin LAR(R) Depot Controls Tumor Growth in Patients With Rare Gastrointestinal Tumors

... months for patients on placebo. This beneficial effect was seen in patients with either functioning ... but these are the first data to confirm this effect from a well-designed, prospective, ... at 18 sites in Germany to evaluate the antitumor effect of Sandostatin LAR in patients with NETs. The ...

Longevity Seekers Advised to Consume Modest Doses of Red Wine Molecules in Dietary Supplements (Longevinex(R)) Rather than Mega-Dose Resveratrol Alone

... Cause of shortened lifespan The negative effect upon lifespan with mega-dose resveratrol may ... per kilogram of body weight), but the longevity effect was only demonstrated among mice engorged with a ... Synergism found "A synergistic effect has been demonstrated with the array of ...

Major deCODE-led Study Underscores Role of the Brain in Obesity

... and to form collaborative relationships, the effect of a potential delisting of our common stock from ... and the completion of clinical trials, the effect of government regulation and the regulatory ... dependence on collaborative relationships, the effect of competitive products, industry trends and ...

Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial

... drug with a single breath and achieve therapeutic effect as quickly as an intravenous injection -- a ... no serious adverse events. The only common side effect reported (> 10% in any treatment group) was taste (dysgeusia). This side effect was rated as mild in all patients and occurred in ...

Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer

... the anti-Factor Xa activity, or the anticoagulant effect of the drug, which was sustained for at least ... included the reversal of the anticoagulant effect of idrabiotaparinux, as there are medically ... anticoagulant. The reversal of the anticoagulant effect was measured after a 30-minute intravenous ...

First Clinical Experience With Soliris(R) in Treating Patients With Two Rare Complement-Mediated Diseases Presented at ASH Annual Meeting

... and his colleagues investigated the potential effect of eculizumab in two patients with aHUS, a rare ... and his colleagues investigated the potential effect of eculizumab therapy in one patient with CAD, a ... not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy ...

Pharmacyclics Announces Completion of Phase 1 Clinical Trial of Factor VIIa Inhibitor PCI-27483

... to evaluate the safety and pharmacologic effect of PCI-27483. A single administration of ... "PCI-27483 is expected to have a dual effect of inhibiting tumor growth and decreasing the ... from preclinical and clinical studies, expected effect of our products under development, ...

Pharmos Announces Clinical Results from Phase 2a Trial of Topical Diclofenac NanoEmulsion Cream

... endpoint, nor in several secondary endpoints. The effect witnessed did not measure up to other topical ... related. No Serious AE's were reported and the effect of the NanoEmulsion cream on the skin was ... which it demonstrated a statistically significant effect compared to placebo on the primary efficacy ...

VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease

... placebo. In order to further evaluate VIA-2291's effect over a longer timeframe, a sub-study of ... The CEA Phase 2 study evaluated VIA-2291's effect on atherosclerotic vascular inflammation in 50 ... to provide direct evaluation of VIA- 2291's effect on inflammation by analyzing plaque removed from ...

Physicians' Health Study II Finds No Magic Bullet for Preventing Cardiovascular Disease

... of nutrients. With regard to the possible effect of vitamin E on increased risk of hemorrhagic ... trial of male smokers in Finland reported such an effect in 1994 with a dose of only 50 IU of vitamin E. Such an effect was not seen in numerous other trials using ...

Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

... itself was not designed to compare the relative effect of paliperidone ER as a monotherapy or in ... mood stabilizers, however, results showed the effect of paliperidone ER was evident in both patients ... (NMS) is a rare and potentially fatal side effect reported with paliperidone and similar medicines. ...

CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years

... trials produced a fast and clinically meaningful effect for RA patients over an extended period of time," ... data. Additional data presented focused on the effect of treatment with CIMZIA together with MTX in ... There is no evidence that CIMZIA therapy has an effect on in vivo coagulation. Cases of worsening ...

Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial

... continue to its final analysis. "The treatment effect we have observed in this interim analysis ... officer of Dendreon. "Given the delayed treatment effect we have seen in previous studies, we are pleased ... The hazard ratio is an estimate of the treatment effect in the treated versus the control group in a ...

Uroplasty Enrolls First Patients in Urgent(R) PC Clinical Trial

... studies and written extensively on the effect of neuromodulation in treating voiding ... We discuss in detail the factors that may effect the achievement of our forward-looking statements ... from infringing our rights; -- the effect of government regulation, including when and if ...

Access Pharmaceuticals Presents New Data on the Company's Angiolix(R) Therapeutic Monoclonal Antibody

... lactadherin, Angiolix has both an anti-angiogenic effect as well as a direct anti-proliferative effect on tumors themselves. In preclinical models of ... (MX-1), Angiolix had a significant anti-cancer effect in vivo; ...

Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval

... Inc. "The anti-inflammatory effect and safety profile seen in the varespladib trials ... of Cardiologists by GlaxoSmithKline on the effect of their selective ... on a secondary biological outcome while having no effect on inflammation or LDL-C, provides encouraging ...

Five-Year Data Confirm That Early Treatment with Betaseron(R) at First Sign of Disease Can Delay Progression to MS

... early treatment with Betaseron had a beneficial effect on cognition that became even more pronounced ... (EDSS), with early versus delayed treatment. This effect first appeared at year three, with a significant ... or after two years (p=0.014; Poisson model). This effect was mainly due to the differences between the ...

Newly Released Data on Onset of Effect and Patient Perception With SYMBICORT in Adults With Asthma

... and patient perception of onset of effect was assessed in two 12-week randomized, ... Effect In these studies, perception of onset of effect was assessed in two ways.(1) Patients completed the Onset of effect Questionnaire(c)(OEQ), a validated ...

Diffusion Pharmaceuticals Announces Initiation of a Phase I/II Clinical Trial in Patients with Peripheral Arterial Disease (PAD)

... TSC; establish a dose-response relationship and effect of TSC on peak walking time and claudication ... intermittent claudication patients; determine the effect of TSC on potential hypoxia biomarkers; and ... a proof-of-concept Phase I study evaluating the effect of TSC on the oxygen levels of brain tumors in ...

Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber

... month - A highly statistically significant effect of Oralair(R) Grasses versus placebo (p=0.0003) ... - A Cohen score of 0.79 corresponding to a large effect size Safety results, with only well-known local ... Moreover, it confirms the therapeutic effect of Oralair(R) Grasses and the very fast onset of ...

Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates

... meet its two primary endpoints, which were the effect of AZ-002 on the incidence of a doxapram-induced panic attack and the effect of AZ-002 on the duration of a doxapram-induced ... and the clear IV-like pharmacological effect demonstrated to date, Alexza and Symphony Allegro ...

Phase II Data on Lilly's Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimer's Disease

... as an indirect measure of the effect of the antibody on amyloid beta present in the ... and cerebrospinal fluid. We hypothesize that this effect may lead to reduced formation of amyloid plaques ... To date, the most frequently occurring side effect experienced in clinical studies with LY2062430 ...

Four Alzheimer's Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation

... (p=0.009 and p=0.041, respectively). PBT2 had no effect on the ADAS-cog in this trial. The researchers ... both mild and moderate Alzheimer's. The overall effect size was -6.8 ADAS-cog units vs. decline of 7.8 ... at the 60mg dose produced a significantly larger effect size at 50 weeks than at 24 weeks implying ...

Soyfoods Do Not Impact Sperm Count

... the higher intake individuals. This watering-down effect of sperm concentration should not be ... amounts of isoflavones from soy were fed and no effect on quantity, quality or motility of sperm were ... hormones but rather has suggested a preventive effect in prostate cancer." Learn the facts about ...

Independent Analyses of the SEAS, SHARP and IMPROVE-IT Studies of Ezetimibe

... do not provide credible evidence of any adverse effect on cancer. Allocation to 5 years of substantial ... has been shown previously to have no apparent effect on cancer. The Cholesterol Treatment Trialists' ... vs 72 fatal cases. If there were a real adverse effect on cancer incidence or cancer mortality then ...