The agency's Committee for Medicinal Products for Human Use recommended AstraZeneca's brodalumab for the treatment of moderate-to-severe plaque psoriasis. / read more /
CBER is moving forward with the development and approval of regenerative medicine advanced therapies. / read more /
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Podcast
Finn Bauer talks about Parteck SRP 80, an excipient for direct compression of matrix-based, sustained-release tablets. Parteck SRP 80 won the Excellence in Excipients Award at the 2016 CPhI Pharma Awards.
Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company's new biosimilar infringed on its Remicade patents. / read more /
The compendium provides a resource to identify and locate targeted suitable patient-derived xenografts based on specific histology and molecular properties. / read more /
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates. / read more /
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products. / Click here /
Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.
