All Biologics formulation and stability articles – Page 3
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NewsSandoz breaks ground on new European biosimilar plant
The new investment will help Sandoz to expand its European biosimilar manufacturing capacity and ensure reliable and sustainable supply in the region.
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ReportBioprocessing / Bioproduction In-Depth Focus 2025
This in-depth focus features articles on biosimilars and biomanufacturing in Europe, the potential of plant tissue-based bioproduction and utilising digital twins for optimisation of bioprocesses.
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PublicationEuropean Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
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NewsNICE concludes decision for two Alzheimer’s treatments
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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ArticleNew biosimilar pathways – key takeaways from the EMA’s draft reflection paper
Gain insight on the European Medicines Agency (EMA)’s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU.
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NewsEnhancing chromatographic protein purification with light
The method offers an alternative approach for efficient control in affinity chromatography as a separation technique, researchers propose.
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NewsUCB commits to major US biologics manufacturing investment
The investment will support the company’s long-term vision for its future manufacturing capacity and medicine pipeline.
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NewsR&D and tech innovation boosting biopharmaceutical market to 2030
Advanced technology innovation is driving lower R&D costs and progress of targeted treatments such as cell and gene therapies, the research reports.
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NewsNew technology could enhance CAR T therapy manufacture
The innovative device could improve CAR T cell cancer immunotherapy and facilitate its use as a first-line therapy, research suggests.
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NewsCHMP meeting highlights - May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
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NewsNew J&J data signals progress in ulcerative colitis treatment landscape
The biologic delivered sustained remission in adults with the inflammatory bowel disease (IBD) over the two-year study, results show.
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NewsCHMP meeting highlights – April 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a variety of new medicines, including several treatments for hereditary and rare conditions.
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NewsGSK to advance antibody medicines for neurodegenerative diseases
The licensing agreement will support development of medicines for delivery across the blood-brain barrier to treat neurological disorders like Alzheimer’s and Parkinson’s.
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NewsEMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
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NewsTariffs could threaten medicine innovation, industry bodies warn
Biotechnology Innovation Organization (BIO) and the International Generic and Biosimilar medicines Association (IGBA) highlight the need for industry cooperation to support the potential impact of tarrifs.
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NewsInvestigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
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NewsAlzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
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NewsNovartis nets potential first-in-class medicine in new cardiovascular acquisition
The potentially multi-billion-dollar deal strengths Novartis’ late-stage pipeline for cardiovascular therapies, signalling advancement of novel treatments for heart disease.
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NewsBiologic could reduce treatment burden for children with haemophilia A
New data suggests that once-weekly prophylaxis bispecific antibody treatment could provide an efficient and convenient option for young patients with haemophilia A.
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NewsCHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.