All Data Analysis articles – Page 3
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ArticleA four-step way out of pharma manufacturing's asset management struggles
Here, Hexagon outlines a four-step plan to address silos and scale-up challenges, drawing on the experience of leading pharma firms like Pfizer.
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NewsImpurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
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NewsGamida Cell wins cell therapy first in severe aplastic anaemia from FDA
The US approval for the Ayrmid company’s novel transplant option Omisirge adds to its existing licence in haematological malignancy.
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NewsBristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi
The FDA’s latest authorisation makes it the most widely approved of any CD19-directed CAR T therapy in cancer.
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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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Regeneron and Tessera partner to develop gene therapy for AATD
The in vivo, one-time gene editing therapy has potential to transform outcomes for alpha-1 antitrypsin deficiency (AATD).
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ArticleEuropean Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
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NewsAbbVie’s atogepant illustrates migraine therapy label expansion potential
If approved in Europe, atogepant would provide patients with a new acute treatment option for migraine attacks.
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Innovative antibiotic-free method could limit biofilm formation
The proposed mechanical antibacterial approach offers a new way to use metal-organic frameworks, a Nobel Prize-winning material.
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Chiesi gains pace on climate target with new carbon minimal inhaler data
Findings presented at the British Thoracic Society (BTS) Winter Meeting back biopharma’s Net Zero commitment.
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NewsDupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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NewsInsmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
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Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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NewsThermally driven chemical reaction shows drug manufacturing promise
The “simple” approach for initiating electron transfer reactions could enable synthesis of small molecule drugs, researchers say.
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NewsRaman-based PAT tool could advance continuous vaccine manufacturing
Study demonstrates the non-invasive tool’s potential for real-time monitoring of cytomegalovirus (CMV) viral particles.
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NewsAlexion wins EU label expansion for kinase inhibitor Koselugo
Approval provides continuity of care into adulthood for patients with neurofibromatosis type 1 (NF1) using Koselugo (selumetinib) to manage symptoms.
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NewsPhase III data for next-gen green inhaler push GSK closer to Net Zero targets
New findings support use of salbutamol MDI formulation in the next-generation low carbon propellant as a more sustainable option for patients with respiratory disease.
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NewsIpsen strikes €1bn deal to acquire French biotech ImCheck Therapeutics
The move will boost its oncology pipeline, adding a potential first-in-class anti-BTN3A monoclonal antibody for acute myeloid leukaemia.
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NewsUV contamination control robot shows pharma cleanroom promise
Efficacy research supports the widespread use of autonomous UVC disinfection for microbial surface decontamination, say AstraZeneca microbiology experts.
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NewsKeytruda post-surgery could halt return of distant tumours in rare skin cancer
Merck & Co’s anti-PD-1 immunotherapy showed evidence at ESMO of its ability to prevent cancer recurrence in Merkel cell carcinoma.