Early Phase Development

FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.

EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.

Therapeutics targeting epigenetic mechanisms of disease will change the pharmaceutical marketplace.

AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott's tumor necrosis factor inhibitor monoclonal antibody adalimumab.

How does working in a virtual biotech environment affect biosimilar development? Anjan Selz outlines target and partner selection in this first of a two part article.

MorphoSys AG (Munich, Germany) and Galapagos NV (Mechelen, Bengium) have launched a long-term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis, and osteoarthritis.