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Aeterna to present two novel anticancer compounds at Bio Partnering North America conference

Aeterna Zentaris Inc. today announced that its Vice President, Alliance Management and Intellectual Property, Eckhard Guenther, Ph.D., will make a presentation on two of the Company's novel anticancer compounds, AEZS-108 and AEZS-129, at Bio Partnering North America on Monday, February 28, 2011, at 4 p.m. in the West Meeting Room 218, of the Vancouver Convention Center in Vancouver, Canada.

23 Feb 2011

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

Tranzyme Pharma and Norgine B.V., have initiated dosing of ulimorelin in the first of two, Phase 3 pivotal studies - ULISES. Ulimorelin is Tranzyme's intravenous promotility agent in development for the management of postoperative ileus in hospital and acute care settings.

23 Feb 2011

ISCTM 7th annual meeting to discuss drug development based on amyloid hypothesis of Alzheimer's disease

Continuing in their mission to promote advances in the development and use of CNS therapeutic agents, the International Society for CNS Clinical Trials and Methodology (ISCTM) met February 21, 2011 in Washington, D.C. to discuss one of the most important issues facing the field today.

23 Feb 2011

Scientists receive HHS grant to investigate DSC127 in treatment of skin injuries linked with radiation exposure

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced that researchers who invented DSC127 have been awarded a $4.5 million, 16-month grant by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority to investigate preclinically the use of DSC127 in the treatment of skin injuries associated with acute radiation exposure.

23 Feb 2011

Survey: 67% of pharma and biotech companies outsource more than half of all clinical trials

Driving clinical development and speeding time to market through effective relationship management will be two of the key themes discussed at Pharma IQ's 2nd Annual Global Clinical Outsourcing Forum this May.

23 Feb 2011

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

Amgen today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors or multiple myeloma, which compared XGEVA to Zometa in preventing skeletal-related events.

23 Feb 2011

American Journal of Clinical Oncology publishes CTI's OPAXIO phase II results against esophageal cancer

Cell Therapeutics, Inc. announced today that updated phase II study results of OPAXIO in patients with advanced esophageal cancer conducted by the Brown University Oncology Group were published in the February 3, 2011 issue of the American Journal of Clinical Oncology, Dipetrillo, et al., which demonstrate that 38% of the patients receiving OPAXIO in combination with cisplatin and concurrent radiation achieved a pathologic or endoscopic complete response.

23 Feb 2011

Positive results from Harbor BioSciences' Triolex initial preclinical study for treatment of PD

Harbor BioSciences, Inc., which is investigating the use the company's proprietary compound Triolex as a treatment for Parkinson's disease with funding from The Michael J. Fox Foundation, announced positive results in initial preclinical studies.

23 Feb 2011

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review time from submission to FDA action is ten months.

22 Feb 2011

TransPharma completes ViaDor-GLP1 agonist Phase 1b trial for treatment of type II diabetes

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today the successful completion of a Phase 1b trial of ViaDor-GLP1 agonist, which is being developed for the treatment of diabetes mellitus type II.

22 Feb 2011

Infinity commences IPI-926 Phase 2 trial in patients with pancreatic cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of the randomized Phase 2 portion of the trial of IPI-926 in combination with gemcitabine in patients with previously untreated, metastatic, pancreatic cancer.

22 Feb 2011

KemPharm commences KP201 Phase 1 trial for pain

KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers with KP201, its novel abuse deterrent prodrug of hydrocodone for pain. KP201 is a new chemical entity and is the most advanced opioid-based lead candidate in KemPharm's emerging pipeline.

22 Feb 2011

Pieris: New interim PRS-050 Phase I data against cancer to be presented at Tri-Conference in California

Pieris AG announced today the upcoming presentation of new preclinical and interim Phase I clinical trial data for its PRS-050 Anticalin(r) program, currently under evaluation for the treatment of cancer.

22 Feb 2011

Positive preliminary data from Fate Therapeutics FT1050 Phase 1b trial in patients with life-threatening conditions

Fate Therapeutics, Inc. presented encouraging preliminary data from an ongoing Phase 1b clinical trial of FT1050 at the 2011 BMT Tandem Meetings in Honolulu, Hawaii.

22 Feb 2011

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema.

22 Feb 2011

Positive results from TMC435 phase 2b PILLAR study in treatment-naive patients with HCV

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR study of TMC435 in treatment-naive patients with hepatitis C virus genotype-1.

22 Feb 2011

Advancell announces positive results from Acadra clinical study in Chronic Lymphocytic Leukemia

ADVANCELL, an emerging biopharmaceutical company, today announced positive results from a clinical study conducted with Acadra (Acadesine) in Chronic Lymphocytic Leukemia patients resistant to current therapies. The company also announced promising non-clinical results in Multiple Myeloma (MM), Mantle Cell Lymphoma (MCL) and other lymphoproliferative disorders. Synergism of Acadra in combination with current treatment in these indications has been demonstrated.

21 Feb 2011

Synexus creates specialist vaccines team to help pharma and biotech companies

Synexus has created a specialist vaccines team to help pharma and biotech companies find the thousands of patients they need for their late phase trials. The company has a well-established reputation for delivering results in the vaccine field following successes in late phase vaccine trials including most recently, studies for cancer prevention, influenza and rotavirus where it has delivered in excess of three thousand randomised patients in all three areas.

From AES - Accelerated Enrollment Solutions 21 Feb 2011

Bangladesh cholera vaccine trial

Bangladesh will conduct the world’s largest clinical trial of an affordable cholera vaccine which could save tens of thousands of lives. The study began Thursday and involves nearly 250,000 people near the capital, Dhaka.

20 Feb 2011

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

Protalix BioTherapeutics, Inc., announced today that new clinical data from the switchover trial of taliglucerase alfa in Gaucher disease patients and preclinical data on oral enzyme glucocerebrosidase (oral GCD) will be presented today at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 in Las Vegas, Nevada.

19 Feb 2011

Drug Trial News

Aeterna to present two novel anticancer compounds at Bio Partnering North America conference

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

ISCTM 7th annual meeting to discuss drug development based on amyloid hypothesis of Alzheimer's disease

Scientists receive HHS grant to investigate DSC127 in treatment of skin injuries linked with radiation exposure

Survey: 67% of pharma and biotech companies outsource more than half of all clinical trials

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

American Journal of Clinical Oncology publishes CTI's OPAXIO phase II results against esophageal cancer

Positive results from Harbor BioSciences' Triolex initial preclinical study for treatment of PD

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

TransPharma completes ViaDor-GLP1 agonist Phase 1b trial for treatment of type II diabetes

Infinity commences IPI-926 Phase 2 trial in patients with pancreatic cancer

KemPharm commences KP201 Phase 1 trial for pain

Pieris: New interim PRS-050 Phase I data against cancer to be presented at Tri-Conference in California

Positive preliminary data from Fate Therapeutics FT1050 Phase 1b trial in patients with life-threatening conditions

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Positive results from TMC435 phase 2b PILLAR study in treatment-naive patients with HCV

Advancell announces positive results from Acadra clinical study in Chronic Lymphocytic Leukemia

Synexus creates specialist vaccines team to help pharma and biotech companies

Bangladesh cholera vaccine trial

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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