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NW Bio receives MHRA approval to initiate DCVax-L Phase III GBM brain cancer trial in the U.K.

Northwest Biotherapeutics announced today that it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, for the Company's 300-patient Phase III clinical trial of DCVax-L immune therapy for Glioblastoma multiforme brain cancer (GBM) to proceed in the U.K.

24 Aug 2012

AcelRx commences third ARX-01 Phase 3 study in post-operative pain

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced dosing of the first patient in the third of three planned Phase 3 studies for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia (PCA) system.

24 Aug 2012

Aeras, IDRI announce start of first ID93 + GLA-SE Phase I trial for tuberculosis

Aeras and the Infectious Disease Research Institute (IDRI) announce today the start of the first clinical trial of IDRI's novel tuberculosis vaccine candidate, ID93 + GLA-SE.

23 Aug 2012

Final data from Symphogen's rozrolimupab Phase 2 trial on primary immune thrombocytopenia

The hematology journal BLOOD published today a full-length article describing final Phase 2 data for Symphogen's rozrolimupab, a novel human recombinant mixture of 25 antibodies which all are manufactured simultaneously from a single batch.

22 Aug 2012

CIRT to determine whether methotrexate can reduce heart attacks, strokes and CVD deaths

An international multi-site trial has launched to determine whether a common anti-inflammatory drug can reduce heart attacks, strokes, and deaths due to cardiovascular disease in people at high risk for them. This study is being supported by the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health.

22 Aug 2012

PhaseBio commences Glymera Phase 2b study in type 2 diabetes

PhaseBio Pharmaceuticals, Inc., a privately held, clinical-stage biotechnology company developing drugs to treat diabetes, metabolic disease and cardiovascular disease, announced today that it has initiated dosing in a multicenter (USA), randomized, placebo and active comparator controlled Phase 2b study that will enroll approximately 600 patients with type 2 diabetes (hemoglobin A1c 7% - 11%) inadequately controlled with diet and exercise, metformin, a sulfonylurea or a combination of metformin/sulfonylurea.

22 Aug 2012

Kineta receives regulatory clearance to commence ShK-186 Phase I trial in autoimmune disease

Seattle-based biotech company Kineta, Inc. announced today it has received regulatory clearance in the Netherlands to initiate a first-in-human trial of ShK-186, an autoimmune drug candidate that specifically inhibits the Kv1.3 potassium ion channel.

21 Aug 2012

DPT Labs, Imprimis sign agreement to commence work on Impracor clinical supplies

Imprimis Pharmaceuticals, Inc., a specialty pharmaceutical company developing non-invasive, topically delivered products, announced that it has signed an agreement with DPT Labs to commence work on supplying Imprimis with quantities of its active topical anti-inflammatory drug, Impracor, for currently planned Phase 3 clinical trials.

21 Aug 2012

MitoTarget Project and neurodegenerative diseases: an interview with Rebecca Pruss, Ph.D., CSO of Trophos

The MitoTarget Project was a project funded by the European Commission, under their FP7 programme. It was funding for a call published in 2007.

21 Aug 2012

Medivir initiates MIV-711 phase Ib trial in healthy volunteers

Medivir AB, the research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases, is reporting today that a clinical phase Ib trial of the company's candidate drug (CD) MIV-711 has commenced.

21 Aug 2012

Daily vitamin D intake protects against respiratory infections in children

A study conducted in Mongolian schoolchildren supports the possibility that daily vitamin D supplementation can reduce the risk of respiratory infections in winter. In a report that will appear in the journal Pediatrics and has received early online release, an international research team found that vitamin D supplementation decreased the risk of respiratory infections among children who had low blood levels of vitamin D at the start of the study.

21 Aug 2012

Encouraging results from Ocular Therapeutix's travoprost Phase II trial on glaucoma

Following encouraging results from Ocular Therapeutix's travoprost punctum plug feasibility study, the company is now entering a pilot Phase II clinical trial to examine a two-month sustained release drug (OTX-TP2) for the treatment of ocular hypertension and glaucoma.

21 Aug 2012

BioDiem and French partner VIVALIS a step forward in developing vaccines for diseases and related cancers

Australian infectious disease therapy and vaccine development company BioDiem Ltd (ASX: BDM) announced today successful results from two programs of work carried out by French partner VIVALIS (NYSE Euronext: VLS), confirming the ability of BioDiem’s Live Attenuated Influenza Virus (LAIV) to grow in VIVALIS’ proprietary EB66® cell line.

20 Aug 2012

ARIAD initiates multi-center ponatinib Phase 1/2 clinical trial for CML in Japan

ARIAD Pharmaceuticals, Inc. today announced the initiation of a multi-center Phase 1/2 clinical trial in Japan of ponatinib, the Company's investigational BCR-ABL inhibitor.

20 Aug 2012

Enrollment complete in BDSI's pivotal pharmacokinetic study of BNX for opioid dependence

BioDelivery Sciences International, Inc. announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence has been completed.

20 Aug 2012

Juventas commences treatment in JVS-100 Phase II STOP-HF trial for late stage heart failure

Juventas Therapeutics, a privately-held clinical-stage company developing novel regenerative therapies for treatment of cardiovascular disease, reports treating the first patient in its STOP-HF trial.

20 Aug 2012

FibeBiotics aims to prove benefits of polysaccharides in clinical trials

Staying healthy requires constantly stimulating the immune system. Ingesting non-digestible fibres such as polysaccharides is thought to help. Yet companies including such ingredients in their food products cannot claim that they boost the immune system. At least, not until they have been scientifically tested and proven in clinical trials. Only then, would the European Food Safety Agency (EFSA) allow such health claims.

18 Aug 2012

Promising new treatment for bronchiectasis

Researchers have identified a promising new treatment for non-cystic fibrosis bronchiectasis, a long-term lung disorder which causes persistent coughing and breathlessness. The results, published in The Lancet, could represent an important advance in the treatment of this debilitating disease, for which very few evidence-based treatments are currently available.

17 Aug 2012

Montelukast improves respiratory disturbance and adenoid size in children with OSA

Ben-Gurion University of the Negev (BGU) researchers revealed that a majority of children suffering from Obstructive Sleep Apnea (OSA) treated with montelukast, a drug approved for asthma or hay fever, showed significant improvement in respiratory disturbance and adenoid size, according to a new study published in Pediatrics Journal.

17 Aug 2012

Enzalutamide drug extends survival in people with advanced prostate cancer

Results of a phase III clinical trial of the drug Enzalutamide, published yesterday in the New England Journal of Medicine, show the drug extends life by an average five months in the most advanced stages of prostate cancer.

17 Aug 2012

Drug Trial News

NW Bio receives MHRA approval to initiate DCVax-L Phase III GBM brain cancer trial in the U.K.

AcelRx commences third ARX-01 Phase 3 study in post-operative pain

Aeras, IDRI announce start of first ID93 + GLA-SE Phase I trial for tuberculosis

Final data from Symphogen's rozrolimupab Phase 2 trial on primary immune thrombocytopenia

CIRT to determine whether methotrexate can reduce heart attacks, strokes and CVD deaths

PhaseBio commences Glymera Phase 2b study in type 2 diabetes

Kineta receives regulatory clearance to commence ShK-186 Phase I trial in autoimmune disease

DPT Labs, Imprimis sign agreement to commence work on Impracor clinical supplies

MitoTarget Project and neurodegenerative diseases: an interview with Rebecca Pruss, Ph.D., CSO of Trophos

Medivir initiates MIV-711 phase Ib trial in healthy volunteers

Daily vitamin D intake protects against respiratory infections in children

Encouraging results from Ocular Therapeutix's travoprost Phase II trial on glaucoma

BioDiem and French partner VIVALIS a step forward in developing vaccines for diseases and related cancers

ARIAD initiates multi-center ponatinib Phase 1/2 clinical trial for CML in Japan

Enrollment complete in BDSI's pivotal pharmacokinetic study of BNX for opioid dependence

Juventas commences treatment in JVS-100 Phase II STOP-HF trial for late stage heart failure

FibeBiotics aims to prove benefits of polysaccharides in clinical trials

Promising new treatment for bronchiectasis

Montelukast improves respiratory disturbance and adenoid size in children with OSA

Enzalutamide drug extends survival in people with advanced prostate cancer

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

How electrical engineering ensures accurate calibration and patient safety

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