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May 02, 2023
In this episode, Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.
March 17, 2023
Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.
March 03, 2023
Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.
February 21, 2023
In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.
January 16, 2023
The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.
December 12, 2022
The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.
November 03, 2022
Opportunities and developments in particle engineering are providing developers with the tools to advance drug candidates successfully.
October 18, 2022
In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.
October 14, 2022
One company reaches beyond traditionally-conceived male contraceptives with Vasalgel, a reversible hydrogel injectable.
October 04, 2022
An expert from Aptamer Group reveals the potential of Optimers (a type of aptamer) in the realm of drug delivery, including its targeting capabilities, scalability, and key differences between Optimers and antibody-drug conjugates.