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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

JDRF, iCo Therapeutics collaborate for iCo-007 Phase 2 trial in DME

iCo Therapeutics Inc. today announced that the company has entered into a research collaboration agreement with JDRF, the worldwide leader for research to cure, treat, and prevent type 1 diabetes (T1D), to support the previously announced Phase 2 investigator sponsored clinical trial investigating iCo-007 in Diabetic Macular Edema.

26 Sep 2011

Positive results from Clermont's non-preserved latanoprost phase III trial on glaucoma

Clermont Pharmaceuticals, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today positive results from a phase III trial of non-preserved latanoprost. In the study, non-preserved latanoprost was compared to Xalatan (latanoprost ophthalmic solution) 0.005%, in subjects diagnosed with open-angle glaucoma.

26 Sep 2011

Enrollment complete in Spectrum Pharmaceuticals' belinostat pivotal trial for PTCL

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that it has achieved the target enrollment of the minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the BELIEF registration trial.

26 Sep 2011

Ibandronate controls pain in prostate cancer patients with bone metastases

Many prostate cancer patients develop bone metastases, and controlling the pain these cause can be difficult. Now the first large randomised Phase III trial of a bisphosphonate drug in these patients has shown that a single dose of the drug is as good for pain relief as single dose radiotherapy, the standard treatment for bone metastases. Results of the trial were presented at the 2011 European Multidisciplinary Cancer Congress.

26 Sep 2011

InterMune reports new data from Esbriet clinical trial on IPF

InterMune, Inc. today reported that new data was presented at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet(pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease.

26 Sep 2011

Drug Trial News

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

JDRF, iCo Therapeutics collaborate for iCo-007 Phase 2 trial in DME

Positive results from Clermont's non-preserved latanoprost phase III trial on glaucoma

Enrollment complete in Spectrum Pharmaceuticals' belinostat pivotal trial for PTCL

Ibandronate controls pain in prostate cancer patients with bone metastases

InterMune reports new data from Esbriet clinical trial on IPF

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Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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