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BYETTA-basal insulin combination therapy receives EMA CHMP positive opinion

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion in the European Union for the expanded use of BYETTA (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

17 Feb 2012

Midazolam autoinjector pen more effective in treating status epilepticus

Results have just been released from an NIH study conducted at multiple sites, including the University of Kentucky, indicating that an autoinjector pen is a faster and possibly more effective way for emergency medical personnel to treat serious seizures.

17 Feb 2012

Intramuscular midazolam effective in treating status epilepticus

Drug delivery directly into muscle using an autoinjector is faster and may be more effective in stopping prolonged seizures, according to a study sponsored by the National Institutes of Health and conducted by a Wayne State University School of Medicine researcher.

17 Feb 2012

Rapid intramuscular injection of midazolam drug is safe, effective for status epilepticus

When a person is experiencing a prolonged convulsive seizure, quick medical intervention is critical. With every passing minute, the seizure becomes harder to stop, and can place the patient at risk of brain damage and death. This is why paramedics are trained to administer anticonvulsive medications as soon as possible -- traditionally giving them intravenously before arriving at the hospital.

16 Feb 2012

Thrombocytosis linked to severity of ovarian cancer

Highly elevated platelet levels fuel tumor growth and reduce the survival of ovarian cancer patients, an international team of researchers led by scientists at The University of Texas MD Anderson Cancer center reports in the New England Journal of Medicine.

16 Feb 2012

Midazolam autoinjector may effectively treat status epilepticus

Drug delivery into muscle using an autoinjector, akin to the EpiPen used to treat serious allergic reactions, is faster and may be a more effective way to stop status epilepticus, a prolonged seizure lasting longer than five minutes, according to a study sponsored by the National Institutes of Health. Status epilepticus is a potentially life-threatening emergency that causes 55,000 deaths each year.

16 Feb 2012

UC Cancer Institute to enroll up to 60 patients for AMG 595 phase-1 trial

The UC Cancer Institute is one of three centers internationally approved to test an experimental drug's safety and pharmacokinetics and also assess the clinical benefit against recurrent malignant glioma, an aggressive form of brain cancer.

16 Feb 2012

RUMC conducts early phase trial of MSDC-0160 for dementia

Researchers at Rush University Medical Center are conducting an early phase clinical trial of a novel drug therapy for patients with dementia due to Alzheimer's disease. The drug is a new compound called MSDC-0160, which is an insulin sensitizer that modulates mitochondrial metabolism.

16 Feb 2012

Combination of therapeutic cancer vaccines and chemotherapy shows promise

Therapeutic cancer vaccines, which stimulate the body's immune system to target and destroy cancer cells, are being used in combination with conventional chemotherapy with growing success, as described in several illuminating articles in Cancer Biotherapy and Radiopharmaceuticals, a peer-reviewed journal from Mary Ann Liebert, Inc.

16 Feb 2012

UCSD opens lidocaine and amiodarone clinical trial to prevent SCA

Sudden Cardiac Arrest (SCA) is the leading cause of death in the United States. This form of heart attack kills 325,000 people every year, representing one death every two minutes. Almost all SCA victims die before they even reach a hospital. To identify a drug that paramedics can use in the field, UC San Diego Health System has opened a clinical trial to evaluate two medications to help restore the heart beat.

15 Feb 2012

Amoxicillin not effective for patients with acute rhinosinusitis

Treatment with the antibiotic amoxicillin for patients with acute uncomplicated rhinosinusitis (inflammation of the nasal cavity and sinuses) did not result in a significant difference in symptoms compared to patients who received placebo, according to a study in the February 15 issue of JAMA. Antibiotics are commonly used to treat this condition even though there is limited evidence supporting their effectiveness.

15 Feb 2012

Paricalcitol does not improve clinical outcomes for patients with CKD

Patients with chronic kidney disease who received the vitamin D compound paricalcitol for up to 48 weeks did not show improvement on measures of cardiac structure, function, or left ventricular mass, compared to patients who received placebo, according to a study in the February 15 issue of JAMA.

15 Feb 2012

Aganirsen demonstrates significant activity in two models of wet AMD, ischemic retinopathy

Gene Signal, a company focused on developing innovative drugs to manage angiogenesis based conditions, today announced the publication of data demonstrating the significant activity of aganirsen (GS-101, eye drops) in two important models of retinal neovascular disease, wet age-related macular degeneration (AMD) and ischemic retinopathy.

15 Feb 2012

Nilvadipine phase III trial for Alzheimer's launches in Europe

A research team today announced the launch of a European large-scale clinical trial of Nilvadipine, an Alzheimer's disease drug developed at the Roskamp Institute in Sarasota.

14 Feb 2012

Two studies demonstrate preliminary success of CyBorD in AL amyloidosis

Two studies published today in Blood, the Journal of the American Society of Hematology (ASH), demonstrate preliminary success of an effective multiple myeloma (MM) regimen in patients with AL amyloidosis, a rare and devastating blood disease that results in deposition of damaging abnormal protein in critical organs of the body, including the kidneys, heart, liver, and intestines, and shares some characteristics with MM.

14 Feb 2012

CyBorD regimen shows promise against AL amyloidosis

A Mayo Clinic-led study, published in the American Society of Hematology (ASH) journal Blood found that CyBorD, a triple chemotherapy drug combination that has been successful in helping patients with the blood cancer multiple myeloma, also showed promise in improving the care for patients with the rare blood disease AL amyloidosis.

14 Feb 2012

Diffusion opens enrollment for TSC clinical trial for newly diagnosed primary brain cancer

Diffusion Pharmaceuticals LLC announced today that it has opened for enrollment a clinical trial testing the company's lead drug candidate trans sodium crocetinate (TSC) as a first-line treatment for newly diagnosed primary brain cancer, also known as glioblastoma or GBM.

13 Feb 2012

Third patient dosed in Phase 1/2 SMD trial using RPE cells derived from hESCs

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt's macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

13 Feb 2012

Progesterone vaginal gel 8% NDA transferred to Watson

Columbia Laboratories, Inc., and Watson Pharmaceuticals, Inc., today announced that Columbia has transferred the new drug application for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy (NDA 22-139) to Watson.

13 Feb 2012

Trevena commences TRV130 Phase I clinical trial for severe post-operative pain

Trevena, Inc., the leader in discovery and development of G-protein coupled receptor (GPCR) biased ligands, announced today the initiation of a Phase I clinical trial of TRV130, a novel candidate designed for the intravenous treatment of moderate-to-severe post-operative pain.

13 Feb 2012