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UK £62 billion behind in R&D global investment share, report reveals

European Pharmaceutical Review

The report suggested health research is a key area for R&D investment to align activity with broader social goals, communicate a clear strategic direction and improve R&D funding by crowding novel investment. . The government would need to invest an extra £1 billion in R&D by 2027. billion over a decade.

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EHDS regulation will depend on strong patient confidence

Pharmaceutical Technology

Communication between European Union (EU) member states is ongoing to finalise the details of the legislation, but at its core, the EHDS will provide a single registry of patient data from across the continent. Trust is something that you earn, so how we communicate what’s coming out of this directive is very important.

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Vor Bio back from brink with autoimmune drug deal rising to $4bn

Pharmaceutical Technology

The study, which is expected to produce initial results in the first half of 2027, will support potential approval in the US and Europe. By GlobalData Learn more about Strategic Intelligence RemeGen is conducting a global Phase III clinical trial with telitacicept for the treatment of generalised myasthenia gravis.

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Update on CDER, CBER, and CDRH Meetings with Industry

The FDA Law Blog

The pandemic had changed the way people live, work and communicate. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. Such changes are not limited to personal circumstances. The pandemic also deeply impacted how industry and the government conduct their operations.

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BioOrbit eyes 2026 for pre-clinical trials of space manufactured protein crystals

Pharmaceutical Technology

Then, we will need to run pre-clinical trials of these crystals, which will be in 2026 or 2027. Then the next step is to produce meaningful quantities of these crystals, which will be next year.” After that, it will be about compliance and regulation, as we must ensure that all our processes adhere to pharma regulations.

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

The FDA Law Blog

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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ISPE Represented at PIC/S 50th Anniversary Event

ISPE

Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.