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Final results from Novavax' Phase II clinical trial of trivalent seasonal influenza VLP vaccine announced

Novavax, Inc. a clinical-stage vaccine company, released the final results from a Phase II clinical trial evaluating Novavax's trivalent seasonal influenza Virus-like particle (VLP) vaccine candidate in healthy adults. The study enrolled healthy volunteers 18 to 49 years in age who were immunized with a single injection of Novavax's trivalent seasonal influenza VLP vaccine matched to the influenza strains recommended for the 2008-2009 influenza vaccine.

29 Mar 2010

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Ligand Pharmaceuticals Incorporated today announced that data from a Phase I study with its selective androgen receptor modulator (SARM) LGD-4033 was featured today in a poster presentation at the 14th International Congress of Endocrinology in Kyoto, Japan. This Phase I clinical trial was the first study in humans of LGD-4033, and evaluated the safety, tolerability and pharmacokinetic profiles of the molecule in a single escalating dose, double blind, placebo-controlled study in 48 healthy volunteers.

29 Mar 2010

Glue ear: Bacterial nasal spray may help children

Many children have long-term problems with fluid in the middle ear, and sometimes surgery is the only way to shift it. However, a bacterial nasal spray can have the same effect in some children, reveals a thesis from the Sahlgrenska Academy at the University of Gothenburg, Sweden.

29 Mar 2010

Early stopping of clinical trials result in misleading estimates of treatment effects: Study

An international study of nearly 100 clinical trials that were stopped early due to positive treatment effects has found that many of those effects were exaggerated. The authors of the study — published in the current issue of the Journal of the American Medical Association — recommend that researchers resist pressures to end clinical trials early and continue trials for longer periods before even considering premature termination.

27 Mar 2010

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

Graceway® Pharmaceuticals announced today that the Food and Drug Administration has approved the New Drug Application for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses.

27 Mar 2010

Anxiety may rise again, says Rutgers University dean

Poet W.H Auden dubbed the post-World War II nuclear era the "age of anxiety" and indeed, at the time, anxiety disorders were the most commonly diagnosed mental illnesses. Yet, by the 1990s, American psychiatry was "Listening to Prozac" and instead of obsessing about angst, it focused its attention on depression.

26 Mar 2010

Pravastatin benefits elderly carriers of KIF6 gene variant with prior vascular disease

Celera Corporation today announced the publication of data reporting that elderly (over age 70) carriers of the KIF6 gene variant with prior vascular disease received significant benefit from pravastatin (Pravachol®) therapy. Previous research has shown that a variant of the KIF6 gene, a member of the molecular motor protein kinesin family, is associated with up to a 55% increased risk of primary and recurrent coronary heart disease (CHD) events in the placebo arms of the clinical trials, and that this increased risk is virtually eliminated with statin therapy.

26 Mar 2010

$UCSF study: Unusual femur fractures low in patients with osteoporosis$

UCSF study: Unusual femur fractures low in patients with osteoporosis

The occurrence of an unusual type of fracture of the femur, or the thigh bone, is very low in patients with osteoporosis, including those treated with the drug family known as bisphosphonates, according to a new study led by a team of UCSF epidemiologists.

26 Mar 2010

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

Oramed Pharmaceuticals Inc. announced today the completion of its' pivotal Phase 2b clinical study of its oral insulin capsule, ORMD-0801. The Company expects to report results from this study within the coming weeks.

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Novavax, Inc. announced today positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine.

26 Mar 2010

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Santarus, Inc., a specialty biopharmaceutical company, today announced the completion of enrollment of 510 patients in a U.S. Phase III clinical study to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the second Phase III clinical study being conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA, as part of the budesonide MMX Phase III clinical program for U.S. registration.

26 Mar 2010

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

Eisai Inc. announced today that the Phase III ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial of the investigational compound eritoran (E5564) will continue enrolling to the preset goal of 2,000 patients. As part of a planned interim analysis, an independent Data Monitoring Committee (DMC) has evaluated efficacy and safety data on the first 1,500 subjects to complete the 28-day follow-up in the Phase III ACCESS trial.

26 Mar 2010

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Aastrom Biosciences, Inc., a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported that the final patient has been treated in the company's ongoing multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. This patient received intramuscular injections of either Aastrom's tissue repair cells (TRCs) or electrolyte solution (placebo) for the treatment of critical limb ischemia (CLI), the end-stage of peripheral arterial disease.

26 Mar 2010

DARA BioSciences announces the initiation of Phase I clinical study for DB959

DARA BioSciences, Inc. announced that it has initiated a Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. The study will enroll approximately 75 volunteers and will be conducted at Quintiles' Overland Park facility.

26 Mar 2010

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Arena Pharmaceuticals, Inc. announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

25 Mar 2010

Isotechnika Pharma releases fourth quarter financial results; reviews operational and scientific highlights for 2009

Isotechnika Pharma Inc. has released its financial results for the fourth quarter and year ended December 31, 2009 and provided a review of the Company's operational and scientific highlights for 2009

25 Mar 2010

MediciNova reports net loss of $5.9 million for 2009 fourth quarter

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced financial results for the fourth quarter and full year ended December 31, 2009.

25 Mar 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Xifaxan drug receives FDA approval

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease.

25 Mar 2010

Placebo News and Research

Final results from Novavax' Phase II clinical trial of trivalent seasonal influenza VLP vaccine announced

Ligand Pharmaceuticals' LGD-4033 SARM Phase I study data featured at 14th endocrinology congress

Glue ear: Bacterial nasal spray may help children

Early stopping of clinical trials result in misleading estimates of treatment effects: Study

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

Anxiety may rise again, says Rutgers University dean

Pravastatin benefits elderly carriers of KIF6 gene variant with prior vascular disease

UCSF study: Unusual femur fractures low in patients with osteoporosis

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

DARA BioSciences announces the initiation of Phase I clinical study for DB959

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Isotechnika Pharma releases fourth quarter financial results; reviews operational and scientific highlights for 2009

MediciNova reports net loss of $5.9 million for 2009 fourth quarter

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Xifaxan drug receives FDA approval

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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