GLP-1RA Alzheimer’s hopes dashed after Novo Nordisk’s semaglutide miss
Novo Nordisk’s Rybelsus (oral semaglutide) has failed to demonstrate efficacy in a late-stage trial in Alzheimer’s disease, denting hopes of …
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Aseptic filling of unstable drug products: How to protect sensitive drugs during the fill finish process
This article explores the typical fill-finish process, the potential impact on unstable drug products, and best practices to protect these …
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Eli Lilly flies the pharma flag in tech-heavy $1tn market cap club
Eli Lilly’s market capitalisation hit the $1tn mark in the past week, becoming the first healthcare company in the world …
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Navigating the FDA’s import operations for pharmaceuticals and biologics
In August 2025, the US Food and Drug Administration’s (FDA) launched the nationalised entry review (NER) programme focused on centralising …
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Investors bet on newer technology and indications for CGTs
As confidence grows for innovative in vivo strategies, some investors are saying they could be the future of the cell …
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FDA awards record number of review designations to ADCs in 2024
Antibody drug conjugates (ADCs) have gained significant momentum in recent years, due to their clinical successes in cancer treatment. Since …
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AstraZeneca to expand biomanufacturing in Maryland, US
AstraZeneca has announced a $2bn investment plan to expand its biomanufacturing presence in the US state of Maryland, aiming to …
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The rise of large-volume injectors: Patient-centric innovation in biologics delivery
For decades, intravenous (IV) infusions in clinical settings were the standard for therapies such as monoclonal antibodies. Today, advances in …
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Vaximm and BCME link on oral cancer immunotherapy platform
OSR Company Vaximm has signed a non-binding term sheet with Swiss-based life sciences investor BCM Europe (BCME) for a potential …
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Galapagos CEO tightens strategic focus in pursuit of key assets
For many observers, Galapagos is in an enviable position. The biotech has a balance sheet of €3bn to call upon …
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“Reckless and harmful”: experts weigh in on CDC’s autism-vaccine link stance
The Centers for Disease Control and Prevention (CDC) has updated its website to state that there could be a link …
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Early planning, outsourcing and digitalisation to break down CGT CMC barriers
Since their inception, cell and gene therapies (CGTs) have shown great promise in treating a plethora of challenging diseases. Despite their …
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Aspen closes $115m in Series C to advance Parkinson’s cell therapy
US-based Aspen Neuroscience has closed a Series C funding round, raising $115m to further the clinical development of its lead …
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Alvotech and Advanz announce EC approval for Gobivaz biosimilar
Alvotech and Advanz Pharma have announced the European Commission’s (EC) marketing authorisations for Gobivaz, a biosimilar to Simponi (golimumab), across …
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CPHI 2025: linker innovation paves the way for a wave of new ADCs
Antibody-drug conjugate (ADC) developers say innovations to linkers, the proteins bridging antibodies to their therapeutic payloads, are opening the door …
