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UCB reports success in phase 3 study of fenfluramine for CDD

Pharma Times

The company is also running an open-label, long-term extension to evaluate safety and tolerability over 52 weeks. UCB noted that fenfluramine was generally well-tolerated in this study, aligning with its established safety profile in previous trials focused on Dravet and Lennox-Gastaut syndromes. This field is required.

Diabetes 128
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Seaport Therapeutics begins phase 2b trial of GlyphAllo for major depression

Pharma Times

Eligible participants may enter an open-label extension phase, receiving GlyphAllo for an additional six weeks. The BUOY-1 study builds on successful phase 1 and phase 2a data and will assess the efficacy, safety and tolerability of GlyphAllo in up to 360 adults over six weeks.

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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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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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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 KalVista’s Ekterly for hereditary angioedema

Pharmaceutical Technology

The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. Ekterly has the potential to become the foundational treatment for HAE and our focus now is on delivering it to the people who need it.”

Packaging 122
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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.