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UK enacts law to decentralise manufacture of personalised treatments

Pharmaceutical Technology

The MHRA has recognised that some practices are better with more flexibility, and that in a technology-enabled world which allows better training, information and communication, flexibility can be enabled without compromising safety. We may still continue to send you service-related and other non-promotional communications.

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

Pharmaceutical Technology

BioOrbit aims to kick off pre-clinical trials to study protein crystals for monoclonal antibodies (mAbs) produced in a pharmaceutical factory in space in 2026. Then, we will need to run pre-clinical trials of these crystals, which will be in 2026 or 2027. Image credit: Rini. com/ Shutterstock.

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BiomX phage therapy shows potent effect in cystic fibrosis trial

Pharma Times

BiomX has already initiated a phase 2b trial of BX004, with topline results expected in the first quarter of 2026. aeruginosa cystic fibrosis infections.”

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

Even well-intentioned policies can create access disparities if communication and operational support are lacking. It is unclear how CMS will communicate this determination or whether stakeholders will be notified and invited to contribute evidence before a new price is set.

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How ICH E6 (R3) is changing clinical trials

Pharmaceutical Technology

Integrated CDMS solutions also facilitate smoother communication and coordination between stakeholders, enabling faster, data-driven decision-making – all increasingly crucial for maintaining oversight and regulatory compliance. The updated ICH E6 (R3) guidelines introduce a range of critical changes aimed at modernizing clinical trials.

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Acumen and JCR partner on brain delivery therapy for Alzheimer’s

Pharmaceutical Technology

Anticipated next steps involve generating preclinical candidate data packages, which will include non-human primate studies expected in early 2026. Their efforts include exploring other oligomer-specific antibodies from Acumen’s library to identify potential lifecycle opportunities beyond sabirnetug alone.

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MHRA approves needle-free adrenaline nasal spray for anaphylaxis

Pharmaceutical Technology

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