The Pharma Data

MAY 15, 2023

Development of the biosimilars will ramp-up over the coming 12-18 months.” Just – Evotec Biologics has developed an optimized proprietary ecosystem for cost-efficient, state-of-the-art drug development and manufacturing. Work is set to begin this year, with full operations provisionally planned for late 2026.

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Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. There are several high-level takeaways from these updates for drug developers.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The study is planned to begin in 2026 and conclude in 2028.

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Perficient: Drug Development

SEPTEMBER 27, 2023

Much of this record-breaking adoption is a result of the unnatural demand caused by regulations. While these regulations and increased supply have improved adoption in some states, this approach also means that consumers in other states have less inventory to choose from and longer wait times.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S.,

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Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. Under this ruling, banks, credit unions, credit card issuers, and other financial service providers must enhance consumer access to personal financial data. The ruling demands action from all non-depository firms (e.g.,

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