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Inovio initiates VGX-3100 Phase II trial in patients with cervical cancer

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it is initiating a Phase II clinical trial for its VGX-3100 DNA vaccine for cervical dysplasia and cancer caused by human papillomavirus.

7 Mar 2011

iPrEx update, bone mineral density study highlighted at day three of 18th CROI

The 18th Conference on Retroviruses and Opportunistic Infections is being held at the Hynes Convention Center in Boston from February 27 through March 2. Day three of this major HIV/AIDS research conference included the following selected presentations from scientists supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

5 Mar 2011

FDA approves change to prescribing information for Gilead Sciences' Letairis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved a change to the prescribing information for Letairis (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms.

5 Mar 2011

Researchers use qMRI to confirm effect of CS treatment in patients with OA

A group of Canadian researchers led by Prof. Jean-Pierre Pelletier, Head of the Osteoarthritis Research Unit at the University of Montreal Hospital Research Centre, published a clinical trial in which they confirm, for the first time using quantitative Magnetic Resonance Imaging, the disease modifying effects of chondroitin sulphate, a symptomatic slow acting drug for osteoarthritis.

5 Mar 2011

Monthly liver enzyme tests not required for PAH patients taking Letairis tablets: FDA

The U.S. Food and Drug Administration today announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

5 Mar 2011

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Results from a Phase 2, 8-week dose-ranging study using low doses of atrasentan in patients with diabetic kidney disease were published this week in the Journal of the American Society of Nephrology. The published study results suggest that atrasentan, used in conjunction with renin-angiotensin system inhibitors, may reduce albuminuria (presence of protein in urine) for patients with type 2 diabetes.

5 Mar 2011

Pfizer's ORAL Sync Phase 3 study of tofacitinib in moderate-to-severe RA meets primary endpoints

Pfizer Inc. today announced that the ORAL Sync Phase 3 study of tofacitinib, formerly known as tasocitinib, an investigational, novel, oral JAK inhibitor, being studied in moderate-to-severe rheumatoid arthritis, met its primary endpoints by showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4 <2.6 at six months.

5 Mar 2011

Nevirapine reduces HIV transmission risk from mother to breastfeeding infants by 75%

Giving breastfeeding infants of HIV-infected mothers a daily dose of the antiretroviral drug nevirapine for six months halved the risk of HIV transmission to the infants at age 6 months compared with giving infants the drug daily for six weeks, according to preliminary clinical trial data presented today.

4 Mar 2011

European Commission approves BMY's ONGLYZA to treat type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved a label update for ONGLYZA in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. The approved dosage for the patient group is a new once-daily 2.5 mg dose.

4 Mar 2011

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Eisai Inc. today announced that the U.S. Food and Drug Administration has approved BANZEL Oral Suspension, 40 mg/mL, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

3 Mar 2011

Rockwell Medical fourth quarter net loss increases to $1.7 million

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported today fourth quarter and full-year 2010 results.

3 Mar 2011

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma. The trial is expected to enroll over 100 patients worldwide.

3 Mar 2011

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Depomed, Inc. announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada for the non-hormonal treatment of menopausal hot flashes.

3 Mar 2011

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Vertex Pharmaceuticals Incorporated announced today interim results from an ongoing, two-part, Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus and human immunodeficiency virus, also known as HCV-HIV co-infection.

3 Mar 2011

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

Osiris Therapeutics, Inc., today announced that it has successfully completed enrollment in a Phase 2 clinical trial evaluating Prochymal, an adult mesenchymal stem cell therapy, in patients experiencing their first heart attack.

3 Mar 2011

Scientists devise new on-line calculator to predict food allergies in children

An on-line calculator that predicts, within seconds, the presence of the three major food allergies in children has been developed by researchers at University College Cork.

2 Mar 2011

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).

2 Mar 2011

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Baxter International Inc. announced today the approval of a European repeat mutual recognition procedure (rMRP) by the Austrian Agency for Health and Food Safety for Baxter's PREFLUCEL seasonal influenza vaccine. The 13 participating European Union countries, including Germany, Spain, United Kingdom and Nordic countries, will formally implement the license on a national level to make PREFLUCEL available for the 2011-12 influenza season.

From Baxter International Inc. 2 Mar 2011

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.

2 Mar 2011

Vaccine-induced cellular immune responses against HIV-1 infection exert selective pressure on the virus

An AIDS vaccine tested in people, but found to be ineffective, influenced the genetic makeup of the virus that slipped past. The findings suggest new ideas for developing HIV vaccines.

2 Mar 2011

Placebo News and Research

Inovio initiates VGX-3100 Phase II trial in patients with cervical cancer

iPrEx update, bone mineral density study highlighted at day three of 18th CROI

FDA approves change to prescribing information for Gilead Sciences' Letairis

Researchers use qMRI to confirm effect of CS treatment in patients with OA

Monthly liver enzyme tests not required for PAH patients taking Letairis tablets: FDA

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Pfizer's ORAL Sync Phase 3 study of tofacitinib in moderate-to-severe RA meets primary endpoints

Nevirapine reduces HIV transmission risk from mother to breastfeeding infants by 75%

European Commission approves BMY's ONGLYZA to treat type 2 diabetes

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Rockwell Medical fourth quarter net loss increases to $1.7 million

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

Scientists devise new on-line calculator to predict food allergies in children

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

Vaccine-induced cellular immune responses against HIV-1 infection exert selective pressure on the virus

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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