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Drug Patent

4 Drugs Facing Key Patent Expirations and Potential Generic Entry From September 2021–November 2021

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Yali Friedman at DrugPatentWatch presents a set of an …

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cell and gene therapies

Regulatory Challenges Associated with the Development of Cell and Gene Therapies

The development of safe and effective cell and gene therapies (CGTs) relies on regulatory compliance and critical selection and qualification of raw materials. Regulatory classifications …

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