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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

Preliminary results from Lexicon’s Phase 1 studies of LX2931 and LX7101 for RA

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, today reported preliminary results from Phase 1 studies of LX2931 and LX7101.

17 Aug 2012

Tofacitinib drug shows promise against moderate-to-severe ulcerative colitis

An investigational drug currently under FDA review for the treatment of rheumatoid arthritis has now shown positive results in patients with moderate-to-severe ulcerative colitis, according to researchers at the University of California San Diego, School of Medicine.

16 Aug 2012

Enzalutamide drug can extend life and improve QOL in men with advanced prostate cancer

The head of one of the UK's leading cancer research organisations has hailed a golden age in prostate cancer drug discovery as for the fourth time in two years results are published finding a new drug can significantly extend life.

16 Aug 2012

Medicago, IDRI receive FDA approval to commence Phase 1 H5N1 vaccine trial

The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc., a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announce that they have been cleared by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for an H5N1 Avian Influenza VLP vaccine candidate.

16 Aug 2012

Cedars-Sinai's ICT-107 doubles median survival of patients with malignant brain tumor

An experimental immune-based therapy more than doubled median survival of patients diagnosed with the most aggressive malignant brain tumor, Cedars-Sinai Medical Center researchers reported in Cancer Immunology, Immunotherapy, published online Aug. 3.

16 Aug 2012

Genocea commences GEN-003 Phase 1/2a study in moderate-to-severe HSV-2 infection

Genocea Biosciences announced today that it has initiated a Phase 1/2a clinical study with its lead candidate, GEN-003. GEN-003 is an investigational vaccine designed to stimulate T cell and B cell immune responses to potentially reduce the frequency and severity of clinical outbreaks associated with moderate-to-severe Herpes Simplex Virus type 2 (HSV-2) infection.

16 Aug 2012

3SBio files APX001 IND application with SFDA in China

Apexigen, Inc., an emerging biopharmaceutical company focused on the discovery and development of monoclonal antibody therapeutics, announced today that its partner, 3SBio [SSRX] of Shenyang, China, filed an Investigational New Drug (IND) application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China.

16 Aug 2012

Recognizing the role of international partnerships in global health

"When you're dealing with a global public health crisis, having an international presence isn't just advisable -- it is imperative," Margaret McGlynn, president and CEO of the International AIDS Vaccine Initiative (IAVI), writes in this post in USAID's "Impact" blog, adding, "That's why the [IAVI], in partnership with USAID, has worked diligently over the past several years to establish itself as a truly global non-profit partner."

15 Aug 2012

Proteonomix receives FDA approval to commence UMK-121 Phase 1 trial in end-stage liver disease

Proteonomix, Inc., a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to initiate a Phase 1 clinical trial with its mobilization technology UMK-121.

15 Aug 2012

FDA requests Biovest to conduct second Phase III trial of BV301 for NHL

Biovest International, Inc., a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., today announced that it conducted a formal clinical guidance meeting with the U.S. FDA to determine the most expeditious U.S. registration pathway for BiovaxID, its personalized cancer vaccine for the consolidation treatment of follicular non-Hodgkin's lymphoma.

15 Aug 2012

Spectrum Pharmaceuticals initiates enrollment in Phase 2b ozarelix study for prostate cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced initiation of patient enrollment in the second part of the Company's randomized Phase 2 clinical program of ozarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, in men with prostate cancer for whom hormonal treatment is indicated.

15 Aug 2012

Compounds in cocoa may help decrease blood pressure

Compounds in cocoa may help to reduce blood pressure, according to a new systematic review in The Cochrane Library. The researchers reviewed evidence from short-term trials in which participants were given dark chocolate or cocoa powder daily and found that their blood pressure dropped slightly compared to a control group.

15 Aug 2012

Latrepiridine reduces level of at least two neurodegeneration-related proteins in mice

The second of two studies on latrepirdine, recently published in Molecular Psychiatry, demonstrates new potential for the compound in the treatment of Alzheimer's disease, Parkinson's disease, sleep disorders, and other neurodegenerative conditions.

14 Aug 2012

Drug Trial News

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

Preliminary results from Lexicon’s Phase 1 studies of LX2931 and LX7101 for RA

Tofacitinib drug shows promise against moderate-to-severe ulcerative colitis

Enzalutamide drug can extend life and improve QOL in men with advanced prostate cancer

Medicago, IDRI receive FDA approval to commence Phase 1 H5N1 vaccine trial

Cedars-Sinai's ICT-107 doubles median survival of patients with malignant brain tumor

Genocea commences GEN-003 Phase 1/2a study in moderate-to-severe HSV-2 infection

3SBio files APX001 IND application with SFDA in China

Recognizing the role of international partnerships in global health

Proteonomix receives FDA approval to commence UMK-121 Phase 1 trial in end-stage liver disease

FDA requests Biovest to conduct second Phase III trial of BV301 for NHL

Spectrum Pharmaceuticals initiates enrollment in Phase 2b ozarelix study for prostate cancer

Compounds in cocoa may help decrease blood pressure

Latrepiridine reduces level of at least two neurodegeneration-related proteins in mice

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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