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July 19, 2016
The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
July 11, 2016
FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.
July 08, 2016
A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.
July 07, 2016
The assay will provide information on biosimilar comparability.
July 06, 2016
Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.
July 02, 2016
Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
Early planning for the integration of clean-in-place systems for equipment cleaning is key.
July 01, 2016
A study by MilliporeSigma and the Economist Intelligence Unit reviews growth drivers and approaches to mitigate risk.
June 28, 2016
The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.