Pharmacovigilance – News and Features
News
pSivida Corp: BrachySil™ Phase IIb Pancreatic Cancer Trials Commence
Study to determine the safety of escalating radiation doses of the BrachySil™ device, with tumor response as a secondary end point.
News
Evotec’s EVT 101 Well Tolerated in Four Week Higher Repeat Dose Safety Study
The study showed in both young and elderly subjects that EVT 101 was well tolerated up to the highest dose tested.
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RegeneRx Completes Enrollment and Dosing of Phase IA Safety Trial for Potential Heart Drug
Phase IA clinical trial involves testing of RGN-352, an injectable formulation of Tß4 for potential use in treating acute myocardial infarction patients.
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Movetis’ M0002 Product Progresses to Phase IIb Trial Following Positive Results in Cirrhotic Ascites
Company’s second most advanced product is progressing to Phase IIb following positive results of a phase IIa multiple-dosing trial for the treatment of ascites.
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Bayer HealthCare and Maxygen Announce Hematology Agreement
The $120 million transaction includes license to Maxygen’s novel biotechnology research platform.
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pSivida Announces Interim Results from the Three-Month Readout of the Human PK Medidur™ FA Study
The three-month human pharmacokinetic study is designed to support the ongoing pivotal Phase III clinical trial of Medidur in DME.
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Same Drug, Different Results: MUHC Researcher on the Path to Personalized Medicine
Minor genetic differences between individuals change the effect of a common medication, study shows.
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Hybrigenics Receives Authorization to Accelerate Inecalcitol Dose Escalation in Phase II Trial
France's regulatory agency has authorized the company to increase inecalcitol dosage in its Phase II clinical trial for hormone-refractory prostate cancer.
News
New Data Demonstrates 5-FU Personalized Chemotherapy Management Assay Provides Similar Performance to More Complicated LC-MS/MS
A new blood test may make it easier to measure and personalize 5-FU dosing for patients undergoing infusion chemotherapy regimens.
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OSI Pharmaceuticals Initiates Clinical Development Program for Anti-Obesity Candidate, PSN602
PSN602 is an oral dual serotonin and norepinephrine reuptake inhibitor and 5-HT1A agonist, being developed for the treatment of obesity.
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