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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time.

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MHRA issues first UK guidance on phage therapies

European Pharmaceutical Review

The document was developed in collaboration with the Phage Innovation Network, industry, clinicians and academic researchers. It also supports the UK 2024-2029 National Action Plan in addressing antimicrobial resistance (AMR) and the organisation’s wider role in ensuring safe, high-quality medicines.