News – Page 4
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NewsFUJIFILM Biotechnologies opens new QC lab in Denmark
New facility expands CDMO’s quality control footprint and biomanufacturing operations.
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NewsFood-grade materials potential alternative for one-dose pharmaceutical packaging
Food packaging films could enhance stability of hygroscopic medications, supporting improved therapeutic outcomes, study finds.
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NewsNew FDA draft guidance to enhance safety of genome editing therapies
Recommendations support next-generation sequencing-based safety evaluation of off-target editing for personalised gene therapies.
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NewsRegeneron and Telix collaborate to advance biologics-based radiopharmaceuticals
Potential $4.3 billion partnership deal to develop next-generation radiopharmaceutical therapies for hard-to-treat cancers.
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NewsEuropean Commission expands Dupixent approval in chronic spontaneous urticaria
New EU authorisation gives monoclonal antibody potential as new standard of care for the chronic skin condition.
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NewsAnalytical framework demonstrates potential in single-use chromatographic purification
Digitally-driven technique supports development of autonomous, continuous biomanufacturing technologies.
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NewsCAR-T therapy could treat severe autoimmune diseases, shows study
Earlier intervention in severe autoimmune diseases may help prevent complications following previous ineffective treatments.
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NewsGilead strengthens ADC capabilities with $5bn Tubulis acquisition
Deal expands the companies’ existing two-year partnership and builds Gilead’s oncology pipeline.
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NewsSurface bioburden study offers insight on non-sterile manufacturing
Microbial load fell within the predefined limit, suggesting contamination was controlled during a single time point.
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NewsTrump imposes 100 percent tariff on imported pharmaceuticals
US administration proffers leeway on tariffs for some drugs, with UK exports benefitting from exemption under the recent UK-US partnership.
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NewsFDA approves Lilly’s small molecule obesity pill Foundayo
New GLP-1 therapy Foundayo is Eli Lilly’s second obesity medicine to be authorised for use in the US.
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NewsEditas Medicine’s gene-edited therapy reni-cel sees early clinical success
The CRISPR–Cas12a autologous stem cell therapy improved total haemoglobin levels in participants with sickle cell disease.
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NewsLilly advances neuroscience portfolio with $7.8bn acquisition of Centessa
Acquisition includes a potential best-in-class asset for excessive daytime sleepiness, broadening Lilly’s capabilities into sleep medicine.
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NewsUCB’s TK2d therapy Kygevvi approved by European Commission
Authorisation of the small molecule therapy in the EU represents a new option for thymidine kinase 2 deficiency, builds on earlier US FDA approval.
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NewsFramework supports microbiota assessment in cleanroom changing rooms
Case study presents a potential benchmarking model for microbial trend data and a data presentation format for pharmaceutical cleanrooms.
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NewsHolistic automation for data integrity, usability and sustainability
IMA Active explores how interconnected, human-centric systems that implement advanced automation and usability can enhance operational efficiency and sustainability in tablet manufacturing.
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NewsNovo Nordisk’s Awiqli first FDA-approved once-weekly basal insulin
The type 2 diabetes injection reduces administration frequency from daily to once per week, enhancing convenience for patients.
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NewsMerck expands haematology pipeline with $6.7bn acquisition of Terns Pharmaceuticals
Deal strengthens Merck’s oncology portfolio with addition of a potential best-in-class oral TKI for chronic myeloid leukaemia.
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NewsUCB positions new Georgia biologics facility as future US manufacturing hub
The biopharmaceutical company’s latest manufacturing venture represents one of the largest investments in Georgia’s history.
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NewsAstraZeneca’s Imfinzi wins EU-first immunotherapy approval in early GI cancers
The approval represents the pharmaceutical company’s third perioperative approval in Europe for an Imfinzi-based regimen.