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Lovastatin appears to be safe, effective for children with neurofibromatosis type 1

Researchers at Children's National Medical Center have found that a cholesterol-lowering statin drug appears to be safe in children with neurofibromatosis type 1 (NF1) and may improve learning disabilities, including verbal and nonverbal memory.

28 Sep 2011

BioLineRx's BL-1020 Phase IIb EAGLE trial data on schizophrenia to be presented at ECSR

BioLineRx, a biopharmaceutical development company, today announced that data from the successfully completed Phase IIb EAGLE study of BL-1020, a first in class GABA-enhanced antipsychotic for the treatment of schizophrenia, will be presented at the 3rd European Conference on Schizophrenia Research (ECSR) held in Berlin, Germany.

28 Sep 2011

MicroDose initiates MDT-637 Phase 1 trial in respiratory syncytial virus

MicroDose Therapeutx, Inc. today announced that the first human subject has been dosed in a Phase 1 clinical trial of MDT-637, MicroDose's inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus.

28 Sep 2011

22nd Century completes enrollment in X-22 Phase II-B smoking cessation study

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, announced today that enrollment of its X-22 Phase II-B clinical trial has been successfully completed; 234 smokers have been randomized in the double-blind, active-controlled, multi-center smoking cessation study.

27 Sep 2011

The Nation examines rise in unregulated drug trials in South America

The Nation examines how a surge in the outsourcing of clinical trials to contract research organizations (CROs) and a resulting increase in the number of trials being conducted in the developing world, where "regulations aren't as onerous, patient recruitment is easier and informed consent is less clearly defined," has led to a rise in unregulated drug trials in South America.

27 Sep 2011

HCRI completes enrollment in dual antiplatelet therapy clinical trial

The Harvard Clinical Research Institute (HCRI) announced today that the enrollment phase of the DAPT Study has been successfully completed. The DAPT Study is a four-year clinical trial investigating the duration of dual antiplatelet therapy (DAPT, the combination of aspirin and a thienopyridine/antiplatelet medication to reduce the risk of blood clots) following drug-eluting stent implantations.

27 Sep 2011

Afraxis to participate in NIH's Therapeutics for Rare and Neglected Disease Program

Afraxis, a San Diego-based biotechnology company developing drugs to treat rare genetic diseases through the modulation of p21-activated kinase (PAK), announced today that it has been selected to participate in the National Institutes of Health's (NIH) Therapeutics for Rare and Neglected Disease (TRND) Program.

27 Sep 2011

Arena, Eisai announce new data from lorcaserin Phase 3 clinical trial program

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that new data analyses from the lorcaserin Phase 3 clinical trial program will be presented in poster sessions at Obesity 2011, the 29th Annual Scientific Meeting of The Obesity Society in Orlando, Florida.

27 Sep 2011

Elevation presents positive data from EP-101 Phase 2a study on COPD at ERS annual meeting

Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today that it presented positive results from a Phase 2a study of EP-101 in patients with moderate to severe chronic obstructive pulmonary disease (COPD), a large and growing disease characterized by significant unmet clinical needs, at the annual meeting of the European Respiratory Society.

27 Sep 2011

Novartis files marketing authorisation with EMA for NVA237 to treat COPD

Sosei Group Corporation, today announces that NVA237 (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA) being investigated as a once-daily treatment for chronic obstructive pulmonary disease (COPD), has been filed by Novartis for marketing authorisation with the European Medicines Agency (EMA), under the brand-name Seebri Breezhaler, triggering a $5m milestone payment to Sosei.

27 Sep 2011

Data from YM BioSciences' nimotuzumab clinical trials to be reported at ECCO-ESMO 2011

YM BioSciences Inc., a drug development company advancing a diverse portfolio of hematology and cancer-related products, today announced that data from several clinical trials of nimotuzumab are scheduled be reported at the 2011 European Multidisciplinary Cancer Congress (ECCO-ESMO), September 23-27, 2011, in Stockholm, Sweden.

27 Sep 2011

Zoledronic acid may extend survival in older breast cancer patients

A drug used to protect bone may extend survival in older breast cancer patients, according to researchers at the Universities of Sheffield and Leeds.

27 Sep 2011

Synta announces results of ganetespib, docetaxel Phase 1 combination study on solid tumors

Synta Pharmaceuticals Corp. announced that results of a Phase 1 study of ganetespib in combination with docetaxel in solid tumors were presented at the Annual Meeting of the European Society of Medical Oncology in Stockholm, Sweden.

27 Sep 2011

Alnylam commences ALN-PCS Phase I trial in severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated dosing in its Phase I clinical trial with ALN-PCS, an RNAi therapeutic targeting proprotein convertase subtilisin/kexin type 9, or PCSK9, for the treatment of severe hypercholesterolemia.

27 Sep 2011

Collegium completes Type A meeting with FDA for COL-003 Phase III chronic low back pain study

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, announced today that it has successfully completed a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed Phase III clinical study for COL-003, the Company's tamper-resistant, extended release oxycodone product utilizing its proprietary DETERx technology.

27 Sep 2011

Smaller and faster clinical drug trials could improve gains in cancer survival

With the advent of personalised medicine, gains in cancer survival over the long term could be improved by running smaller, faster trials with less stringent evidence criteria, a researcher told the 2011 European Multidisciplinary Cancer Congress.

26 Sep 2011

Pacira announces data from EXPAREL clinical study presented at ASPS 2011 meeting

Pacira Pharmaceuticals, Inc. today announced that the company's lead investigational product for postsurgical pain management, EXPAREL, was highlighted in the "Hot Topics in Plastic Surgery" panel at the annual scientific assembly of the American Society of Plastic Surgeons (ASPS) in Denver, Colo.

26 Sep 2011

Zoledronic acid may benefit post-menopausal women with breast cancer

A trial investigating the use of zoledronic acid to aid chemotherapy for breast cancer has found a significant benefit for post-menopausal women, according to results presented at the 2011 European Multidisciplinary Cancer Congress.

26 Sep 2011

Long-term results from ARIAD's ponatinib Phase 1 study on CML and Ph+ ALL

ARIAD Pharmaceuticals, Inc. today announced long-term results of the Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia.

26 Sep 2011

Positive interim data from Aeterna Zentaris' AEZS-108 Phase 1/2 study on prostate cancer

Aeterna Zentaris Inc., today announced positive interim data for the Phase 1 portion of its ongoing Phase 1/2 study in castration and taxane-resistant prostate cancer with its targeted cytotoxic luteinizing hormone releasing hormone (LHRH) analog, AEZS-108.

26 Sep 2011

Drug Trial News

Lovastatin appears to be safe, effective for children with neurofibromatosis type 1

BioLineRx's BL-1020 Phase IIb EAGLE trial data on schizophrenia to be presented at ECSR

MicroDose initiates MDT-637 Phase 1 trial in respiratory syncytial virus

22nd Century completes enrollment in X-22 Phase II-B smoking cessation study

The Nation examines rise in unregulated drug trials in South America

HCRI completes enrollment in dual antiplatelet therapy clinical trial

Afraxis to participate in NIH's Therapeutics for Rare and Neglected Disease Program

Arena, Eisai announce new data from lorcaserin Phase 3 clinical trial program

Elevation presents positive data from EP-101 Phase 2a study on COPD at ERS annual meeting

Novartis files marketing authorisation with EMA for NVA237 to treat COPD

Data from YM BioSciences' nimotuzumab clinical trials to be reported at ECCO-ESMO 2011

Zoledronic acid may extend survival in older breast cancer patients

Synta announces results of ganetespib, docetaxel Phase 1 combination study on solid tumors

Alnylam commences ALN-PCS Phase I trial in severe hypercholesterolemia

Collegium completes Type A meeting with FDA for COL-003 Phase III chronic low back pain study

Smaller and faster clinical drug trials could improve gains in cancer survival

Pacira announces data from EXPAREL clinical study presented at ASPS 2011 meeting

Zoledronic acid may benefit post-menopausal women with breast cancer

Long-term results from ARIAD's ponatinib Phase 1 study on CML and Ph+ ALL

Positive interim data from Aeterna Zentaris' AEZS-108 Phase 1/2 study on prostate cancer

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

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