All Biologics formulation and stability articles
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WebinarOptimising efficiency and yield through bioprocessing automation
Join this webinar to explore how process Raman spectroscopy can support bioprocessing automation across upstream and downstream workflows.
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NewsDaiichi Sankyo picks Dr John Tsai to head up R&D
The ex-Novartis drug development head will lead the pharmaceutical company’s global R&D operations.
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NewsAmgen wins new European approval for Uplizna in generalised myasthenia gravis
The EC decision clears a new first-in-class approach to manage the rare autoimmune condition.
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NewsFujifilm Biotechnologies inaugurates expanded £400m UK biomanufacturing site
The CDMO’s investment in the North-East based site expansion supports UK production of medicines and vaccines.
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NewsGSK’s Nucala green lit for COPD in expanded EU approval
The EC's decision opens up the monthly biologic for use by COPD patients with an eosinophils phenotype.
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NewsGSK acquires food allergy firm Rapt Therapeutics for $2.2bn
Will gain access to ozureprubart, a potential best-in-class antibody for food allergies, and expand its respiratory, immunology and inflammation pipeline.
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NewsTeva’s migraine biologic Ajovy marks phase III progress for paediatric patients
The monoclonal antibody could provide a new preventative treatment option for episodic migraines, new late-stage data suggests.
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AbbVie licenses novel bispecific antibody from RemeGen for $5bn
New deal strengthens AbbVie's oncology portfolio, adding a new class of cancer therapeutics to its inventory.
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ArticleLiterature as data – using large language models to prioritise protein binding pockets
Here, Alan Nafiiev, CEO and founder of Receptor.AI, discusses the benefits of using large language models to integrate literature evidence and structural prediction to accelerate binding site identification.
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NewsNovartis chromatography study shows downstream purification benefits
The impurities research illustrates an approach that could offer a simpler and more flexible downstream purification process.
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NewsOff-the-shelf dual-antibody immunotherapy shows myeloma potential
The combination of two J&J biologics demonstrates a significantly improved treatment response for the most aggressive form of multiple myeloma in new phase II data.
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ArticleA careful calibration: balancing small molecule needs and biologic innovation
CDMOs weigh up how to meet manufacturing demands across oral solid doses, monoclonal antibodies, ADCs and beyond.
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NewsEuropean Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
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NewsTakeda expands its ADC and immuno-oncology pipeline as Innovent deal closes
The $11bn collaboration with the Chinese biopharma company gives Takeda the rights to several next-generation candidates.
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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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AstraZeneca furthers US manufacturing commitment with $2bn Maryland investment
The move is part of biopharma's $50 billion pledge to US medicines manufacturing and R&D.
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First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
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MHRA approves Leqembi IV maintenance as additional Alzheimer’s option
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.