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Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.
June 28, 2016
The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.
June 24, 2016
The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.
June 23, 2016
Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.
June 21, 2016
A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.
June 16, 2016
A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.
Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.
The agency provides quality, development, manufacturing, and labeling recommendations.
Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.
June 15, 2016
A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.
June 13, 2016
FDA approved Vaxchora intended for travelers who are at risk for the disease.