Boehringer said that the FDA approval was supported by clinical pharmacokinetic data, and by a single randomised, double-blind, placebo-controlled multicenter clinical trial. A second study evaluated an overnight
In Phase I development of the virus detection system, which utilizes PositiveID’s licensed Receptors’ CARA (Combinatorial Artificial Receptor Array) platform, PositiveID successfully achieved proof-of-concept. CARA support and complementary
The amendment provides Durect with final decision-making authority over clinical trials intended for the US registration of Posidur and Nycomed with decision-making authority over clinical trials for the
By employing demand flow technology throughout its manufacturing system, Segue provides a standardised process and methodology that drives consistent change management and improvement with a proven roadmap and
Hadassah’s Helsinki Committee has approved the commencement of clinical trials with BrainStorm on condition of approval by the National Helsinki Committee of Israel’s Ministry of Health. The agreement
The combination of both companies capabilities creates a comprehensive biological service offering, encompassing cell line development, analytical and process development and GMP production of recombinant proteins, DNA, viruses
Excipients have a key role in the creation of medicines, in order to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs) and ensuring that they
The results of the study have been published in PLoS One under the title: Triple Combination of Amantadine, Ribavirin, and Oseltamivir is Highly Active and Synergistic Against Drug
CEL-SCI’s rheumatoid arthritis vaccine CEL-2000 was discovered as part of work with the company’s ongoing research and development activities with its LEAPS (Ligand Epitope Antigen Presentation System) technology.
Transcept Pharmaceuticals submitted a revised proposal for the resubmission of the Intermezzo New Drug Application (NDA) to the FDA for evaluation and comment. The FDA stated in the
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