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United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen launched by Medicure Inc, a specialty pharmaceutical company. Aggrastat is Antiplatelet drug. It is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Firecrest eConsent is a next-generation electronic informed consent solution introduced by ICON plc, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, that incorporates key recommendations from the FDA’s recent draft guidance on informed consent. It is designed to enhance the engagement of patient populations in the development process. One of the critical parts to improving this engagement is improving the informed consent process.
The European Medicines Agency (EMA) has recommended approval for Opdivo (nivolumab). Opdivo is indicated for treatment of adult patients with advanced (unresectable or metastatic) melanoma.
Fecal matter transplants are more successful in treating Clostridium difficile infections than previously thought, new research has found. The research shows that healthy changes to a patient's microbiome are sustained for up to 21 weeks after transplant, and has implications for the regulation of the treatment.
An important bacterial protein called UmuD may help prevent antibiotic resistance, scientists say. Penny Beuning from Northeastern University's college of science and colleagues are studying UmuD that regulates mutagenesis and may provide important clues about how to sto the process that eventually results in antimicrobial resistance.
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