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Lilly's ixekizumab Phase II trial on plaque psoriasis meets primary endpoint

New Phase II data, published today in the New England Journal of Medicine, showed that Eli Lilly and Company's ixekizumab, an anti-IL-17 monoclonal antibody, met its primary endpoint in patients with moderate-to-severe plaque psoriasis, with significantly more patients achieving at least a 75 percent improvement in Psoriasis Area and Severity Index (PASI) scores from baseline (PASI 75) compared with placebo at week 12.

29 Mar 2012

FDA extends review period for Almirall and Forest Labs' aclidinium bromide NDA

Forest Laboratories, Inc. and Almirall, S.A. announced today that the U.S. Food and Drug Administration (FDA) will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease.

29 Mar 2012

DSMB recommends Bionovo to continue Menerba Phase 3 trial for hot flashes

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced today that the Company's independent Data Safety Monitoring Board (DSMB) recommended that the Phase 3 trial of Menerba (MF101) could continue as designed after an initial review of its clinical safety and tolerability data.

29 Mar 2012

NEJM publishes results from Amgen's brodalumab Phase 2 trial on plaque psoriasis

Amgen announced today that results from a Phase 2 trial evaluating the safety and efficacy of brodalumab in 198 patients with moderate to severe plaque psoriasis were published in the New England Journal of Medicine.

29 Mar 2012

AHF calls on FDA Commissioner Hamburg to step down

AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS organization, today called on Food and Drug Administration (FDA) Commissioner Margaret Hamburg to step down in response to the agency's gross mismanagement of new product reviews and a lack of transparency.

29 Mar 2012

Positive results from Allergan's BOTOX Phase III trials on idiopathic overactive bladder

Allergan, Inc. today announced that two Phase III clinical trials of BOTOX (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints.

29 Mar 2012

Heart attack could be treated best with cheap mix of three injections: Study

When the shot was given early to patients with signs of a heart attack, the mixture of glucose, insulin and potassium (GIK), showed remarkable success in preventing full cardiac arrest - when the heart stops beating - and even death. And each shot cocktail costs only about $US50, according to the research presented at the American College of Cardiology's 61st annual scientific meeting in Chicago. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.

28 Mar 2012

Out-of-hospital use of GIK as therapy for ACS patients needs to be assessed

Patients experiencing symptoms such as chest pain who received from paramedics an intravenous solution consisting of glucose-insulin-potassium (GIK) had no reduction in the rate of progression to heart attack and no improvement in 30-day survival, although GIK was associated with a lower rate of the composite outcome of cardiac arrest or in-hospital death, according to a study appearing in JAMA.

28 Mar 2012

Olaparib improves survival rates in platinum-sensitive relapsed serous ovarian cancer

Today at the Society of Gynecologic Oncology (SGO) 43rd Annual Meeting on Women's Cancer®, Dr. Jonathan Ledermann, Director of Cancer Services and Professor of Medical Oncology at University College London, presented new data updating the overall survival of women enrolled in a "Phase II randomized placebo-controlled study of olaparib (AZD2281) maintenance in patients with platinum-sensitive relapsed serous ovarian cancer."

28 Mar 2012

Placentophagia may offer benefits to human mothers

A paper by neuroscientists at the University at Buffalo and Buffalo State College suggests that ingestion of components of afterbirth or placenta -- placentophagia -- may offer benefits to human mothers and perhaps to non-mothers and males.

28 Mar 2012

GIK can reduce cardiac arrest or death in patients with acute coronary syndrome

Paramedics can reduce someone's chances of having a cardiac arrest or dying by 50 percent by immediately administering a mixture of glucose, insulin and potassium ("GIK") to people having a heart attack, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session.

28 Mar 2012

Top-line results from two Targacept TC-6987 Phase 2 studies on asthma, type 2 diabetes

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced top-line results from two separate exploratory Phase 2 studies of its product candidate TC-6987 conducted in the United States, one in asthma and one in type 2 diabetes.

28 Mar 2012

Experimental drugs from Sanofi and Regenron cut cholesterol in a new way

An experimental drug that acts in a novel way to lower cholesterol proved even more effective than statins and had few undesirable side effects, newly released data shows. The drug acts by modifying the way cholesterol levels are naturally controlled. A protein produced in the liver helps limit the amount of LDL, or “bad” cholesterol, that liver cells can remove from the bloodstream. The new drug, called REGN727, is a monoclonal antibody, made in a laboratory, that blocks the action of that protein.

27 Mar 2012

Simple placebo pill can track footprints of prior antidepressant use

Individuals with major depressive disorder (MDD) often undergo multiple courses of antidepressant treatment during their lives. This is because the disorder can recur despite treatment and because finding the right medication for a specific individual can take time.

27 Mar 2012

SAR236553/REGN727 antibody reduces LDL by up to 72% in patients

A novel monoclonal antibody identified in a new study dramatically lowered circulating LDL cholesterol by 40 percent to 72 percent, a development with potential to provide a new option for patients who are resistant to cholesterol-lowering drugs such as statins or to the current standard of care, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session.

27 Mar 2012

Researchers launch major aspirin trial to eradicate H. pylori

Researchers have launched a major clinical trial to investigate whether eliminating a common stomach bug could help to make taking aspirin safer in some patients.

27 Mar 2012

CSL Behring commences enrollment in SCIg PATH trial for CIDP

CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of subcutaneous immunoglobulin (SCIg), compared with placebo, in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

26 Mar 2012

FDA approves Teva's QNASL nasal aerosol corticosteroid

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has approved QNASL Nasal Aerosol, a new, "dry" nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older.

26 Mar 2012

Stem cells from own bone marrow improve heart function

A research network led by a Mayo Clinic physician found that stem cells derived from heart failure patients' own bone marrow and injected into their hearts improved the function of the left ventricle, the heart's pumping chamber. Researchers also found that certain types of the stem cells were associated with the largest improvement and warrant further study.

26 Mar 2012

Promising results from Esperion ETC-1002 Phase 2 clinical trial for dyslipidemia

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced positive results from a Phase 2 clinical trial for ETC-1002.

26 Mar 2012