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GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

Pharmaceutical Technology

The updated label for GE HealthCare’s positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug’s effectiveness. Can pharma tariffs “Make America Manufacture Again”?

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Tisento’s MELAS treatment receives fast track status from FDA

Pharmaceutical Technology

Subjects who conclude the trial will be qualified for an open-label extension trial. Can pharma tariffs “Make America Manufacture Again”? All subjects will be given zagociguat in one of the 12-week durations and a placebo during the other. Give your business an edge with our leading industry insights.

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Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

Pharmaceutical Technology

Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Can pharma tariffs “Make America Manufacture Again”? Vabysmo generated $4.3bn in sales in 2024, becoming one of Roche’s top-selling drugs, and had high year-over-year growth than Eylea.

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How AI and machine learning are transforming drug discovery

Pharmaceutical Technology

It also identifies off-label usage patterns and relevant comorbidities that may influence therapeutic decisions. Can pharma tariffs “Make America Manufacture Again”?

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How to conduct GMP training for employee

GMPSOP

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. </p>

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FDA approves label updates for BMS’ CAR T cell therapies

Pharmaceutical Technology

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.

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FDA approves label expansion of AbbVie hepatitis C therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. Can pharma tariffs “Make America Manufacture Again”? Credit: © AbbVie Inc. All rights reserved.