Itonis seeks FDA labeler status
Itonis Pharmaceuticals head and the Zicam cold remedy inventor Dr Charles Hensley said that a labeler status is granted to the company that manufactures, repacks or distributes a
Itonis Pharmaceuticals head and the Zicam cold remedy inventor Dr Charles Hensley said that a labeler status is granted to the company that manufactures, repacks or distributes a
The open-label Phase I study is designed to assess the safety, tolerability and pharmacokinetics of MORAb-066 administered with weekly intravenous infusions. Morphotek president and CEO Nicholas Nicolaides said,
Expected to be available in Canada in the third quarter of 2013, Fibristal becomes the first approved medication to reduce fibroid size in addition to controlling symptoms. Actavis
Bayer HealthCare executive committee member and global drug discovery head Prof. Andreas Busch said, "Antibody-drug conjugates are promising approaches in oncology which can attack tumor cells in a
Under the terms of the agreement, Cytokinetics has given rights to Astellas to co-develop and commercialize CK-2127107, a fast skeletal troponin activator drug candidate, for potential application in
BAL30072 is developed to treat severe infections, including nosocomial pneumonia due to multidrug-resistant Gram-negative bacteria. According to the terms of the contract, BARDA will provide nearly $17m of
The collaboration aims to identify preclinical assets against novel targets representing first-in-class opportunities, while Alacrita will support Debiopharm in search for small molecules, antibody or peptide-based product candidates.
The initial three-year term contract has been extended to five years, which will cover sites in the US, Canada, Mexico, Brazil, China, and Singapore, and comes after the
With the continuation of commercial availability until the end of 2013, the temporary suspension was based on the German Federal Joint Committee’s (G-BA) decision on drug’s additional benefits
Commenting on the expansion, Cromos managing director Dr Andrey Tarakanov said, "The staff of our Smolensk office has considerable experience in all stages of clinical trial conduct in