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E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

Soy protein reduces progression of atherosclerosis in women within 5 years of menopause

A new study published in the November 2011 issue of Stroke reveals some promising data on the positive effects of soy protein reducing the progression of clogged arteries in women who were within five years of menopause. This study was the largest and longest randomized controlled human study conducted to-date that directly investigated the efficacy of isolated soy protein consumption on the progression of atherosclerosis.

23 Sep 2011

Researchers to expand malaria vaccine study after initial trial yields encouraging results

Encouraged by early results of a study of an experimental malaria vaccine involving 45 children in Burkina Faso, researchers led by Pierre Druilhe at the Pasteur Institute in Paris are set to expand the clinical trial, resulting in a larger study involving 800 children in Mali, BBC News reports.

23 Sep 2011

Researchers compare safety and effectiveness of cryotherapy, salicylic acid for verrucae

Research has shown no evidence of a difference in clearance rates between patient self-treatment and treatment given by healthcare professional for verrucae.

23 Sep 2011

Levosimendan may effectively improve muscle function in patients with respiratory failure

Treatment with the calcium-sensitizing drug levosimendan may be effective in improving muscle function in patients with respiratory muscle weakness, which often accompanies chronic diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure, according to researchers in the Netherlands, who studied the effects of the drug on healthy volunteers.

23 Sep 2011

Preclinical data from two Pulmatrix's PUR118 study to be presented at ERS 2011

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the prevention, treatment and control of respiratory diseases, today announced that data from two preclinical studies of its inhaled clinical drug candidate, PUR118, will be presented at The European Respiratory Society Annual Congress (ERS 2011), being held September 24-28, 2011, in Amsterdam, Netherlands.

23 Sep 2011

Acetylon initiates ACY-1215 Phase 1-2a clinical trial for multiple myeloma

Acetylon Pharmaceuticals today announced the initiation of patient treatments in a three-part Phase 1-2a clinical trial of ACY-1215, an oral Class II histone deacetylase (HDAC) inhibitor, in adults with relapsed and relapsed/refractory multiple myeloma.

22 Sep 2011

Virginia G. Piper, TGen and Scottsdale Healthcare begin AP26113 Phase 1 study in NSCLC

Patients at Virginia G. Piper Cancer Center Clinical Trials are the first in the nation to participate in a clinical trial to determine the safety, tolerability and preliminary activity of an investigational drug that targets cell-signaling proteins associated with the most common form of lung cancer, as well as other forms of cancer such as lymphomas and neuroblastoma.

22 Sep 2011

Aradigm announces two ciprofloxacin Phase 2b study data on non-CF bronchiectasis

Aradigm Corporation today announced it is presenting data on September 26, 2011, from its Phase 2b studies at the ERS Annual Congress in Amsterdam, Netherlands. The two podium presentations review the results from the Company's two clinical trials of inhaled ciprofloxacin in non-cystic fibrosis bronchiectasis (BE) patients.

22 Sep 2011

Theraclone initiates TCN-032 Phase 1 trial in influenza A

Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, announced today first dosing of subjects in a Phase 1 clinical trial of TCN-032, a broadly protective, fully human monoclonal antibody for the treatment of influenza A virus.

22 Sep 2011

NEJM publishes Boehringer Ingelheim's BIBF 1120 phase II trial on IPF

Boehringer Ingelheim's investigational tyrosine kinase inhibitor (TKI) BIBF 1120 demonstrated a positive trend in reducing lung function decline in patients with idiopathic pulmonary fibrosis (IPF), according to phase II clinical trial results published today online in the New England Journal of Medicine.

22 Sep 2011

S-equol improve appearance of crow's feet skin wrinkles in Japanese menopausal women

A soy germ-based nutritional supplement containing Natural S-equol significantly improved the appearance of crow's feet skin wrinkles of the outer corner of the eyes in Japanese menopausal women, suggesting that supplements containing Natural S-equol have potential to slow skin aging, according to data from a controlled pilot study simultaneously published online in the peer-review journal Menopause and presented in a poster session at the North American Menopause Society annual meeting.

22 Sep 2011

HRPR before PCI procedures linked to increased risk of ischemic event in ACS patients

Among patients with acute coronary syndromes undergoing a procedure such as angioplasty, those who received platelet function tests before receiving antithrombotic therapy to determine appropriate clopidogrel dosing and who had high residual platelet reactivity were at an increased risk of an ischemic event at short- and long-term follow-up of up to 2 years, according to a study in the September 21 issue of JAMA.

21 Sep 2011

Enrollment commences in Boehringer Ingelheim's TOviTO Phase III combination trial for COPD

Boehringer Ingelheim today announced enrolment has commenced in its TOviTO Phase III clinical trial program. It will investigate tiotropium plus olodaterol in a once-daily fixed-dose combination for the treatment of chronic obstructive pulmonary disease.

21 Sep 2011

Ono, Bristol-Myers Squibb partner to develop BMS-936558/ONO-4538 and ORENCIA

Bristol-Myers Squibb Company and Ono Pharmaceutical Co., Ltd., today announced an agreement to expand Bristol-Myers Squibb's territorial rights to develop and commercialize the anti-PD-1 antibody known as BMS-936558/ONO-4538, and to create a strategic alliance for the co-development and co-commercialization of ORENCIA in Japan.

21 Sep 2011

Positive results from Orexo's OX219 clinical study on opioid dependence

Orexo AB (STO:ORX) today announced that it has obtained positive results in a clinical study with OX219, which is being developed for the treatment of opioid dependence.

21 Sep 2011

Niiki Pharma announces positive data from ongoing trial of novel anti-cancer agent NKP-1339

Niiki Pharma Inc. announced interim results from the ongoing Phase I clinical trial of its lead product, NKP-1339. NKP-1339 is a first-in-class transferrin targeted small molecule that down-regulates GRP78, a key regulator of mis-folded protein processing and a tumor survival factor.

20 Sep 2011

Gilead’s new 4 in 1 combo HIV pill works

Gilead Sciences Inc's four-drug experimental HIV pill worked as well as a regimen containing protease inhibitor Reyataz in the second pivotal trial of the drug, the company announced this Monday. Although the trial succeeded, it did not show the experimental pill, called the Quad, was superior to the Reyataz regimen and Gilead shares fell less than a percentage point.

20 Sep 2011

U-M Professor to review data from three prominent studies on heart failure

Roughly 5 million people in the United States live with heart failure, a condition in which the heart is unable to pump blood around the body effectively. The causes and types of heart failure vary greatly, and treatment must be tailored to each patient. In some cases, doctors will prescribe a class of diuretic drugs called aldosterone antagonists.

20 Sep 2011

Gilead’s Quad Phase 3 clinical study in treatment-naïve HIV-1 patients meets 48-week primary objective

Gilead Sciences, Inc. today announced that the second pivotal Phase 3 clinical trial of its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada.

20 Sep 2011

Drug Trial News

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Soy protein reduces progression of atherosclerosis in women within 5 years of menopause

Researchers to expand malaria vaccine study after initial trial yields encouraging results

Researchers compare safety and effectiveness of cryotherapy, salicylic acid for verrucae

Levosimendan may effectively improve muscle function in patients with respiratory failure

Preclinical data from two Pulmatrix's PUR118 study to be presented at ERS 2011

Acetylon initiates ACY-1215 Phase 1-2a clinical trial for multiple myeloma

Virginia G. Piper, TGen and Scottsdale Healthcare begin AP26113 Phase 1 study in NSCLC

Aradigm announces two ciprofloxacin Phase 2b study data on non-CF bronchiectasis

Theraclone initiates TCN-032 Phase 1 trial in influenza A

NEJM publishes Boehringer Ingelheim's BIBF 1120 phase II trial on IPF

S-equol improve appearance of crow's feet skin wrinkles in Japanese menopausal women

HRPR before PCI procedures linked to increased risk of ischemic event in ACS patients

Enrollment commences in Boehringer Ingelheim's TOviTO Phase III combination trial for COPD

Ono, Bristol-Myers Squibb partner to develop BMS-936558/ONO-4538 and ORENCIA

Positive results from Orexo's OX219 clinical study on opioid dependence

Niiki Pharma announces positive data from ongoing trial of novel anti-cancer agent NKP-1339

Gilead’s new 4 in 1 combo HIV pill works

U-M Professor to review data from three prominent studies on heart failure

Gilead’s Quad Phase 3 clinical study in treatment-naïve HIV-1 patients meets 48-week primary objective

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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