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June 27, 2017
Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.
June 12, 2017
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
June 02, 2017
As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.
May 30, 2017
The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.
May 23, 2017
CBER is moving forward with the development and approval of regenerative medicine advanced therapies.
May 22, 2017
Ablynx will receive EUR15 million in milestone payment following Merck’s decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties.
May 15, 2017
Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.