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Keytruda® promising in adjuvant treatment of lung cancer
MSD/Merck reveals Keytruda® (pembrolizumab) significantly improved disease-free survival in adjuvant treatment of non-small cell lung cancer (NSCLC) patients.
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Antibodies
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The weakest link – biopharma workforce development
Killian O’Driscoll, Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT), highlights the plight of a future skills shortage in the global biopharma industry as state-of-the-art therapy production evolves at a rapid pace.
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EMA recommends GSK’s Xevudy for the treatment of COVID-19
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
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FDA authorises Evusheld for COVID-19 prevention
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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MHRA approves Xevudy (sotrovimab) to treat COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) approve sotrovimab for people with mild to moderate COVID-19 infection and at least one risk factor for developing severe illness.
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Technologies and tactics for accelerating end-to-end biologic drug development
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
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AZD7442 reduces COVID-19 risks by 83 percent in Phase III trial
A separate treatment trial showed 88 percent reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
whitepaper
Future of QA/QC for Complex Biologics Whitepaper
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
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Protein catenation to advance development of therapeutic proteins
Higher order protein catenation enables the development of artificial antibodies with improved binding affinity and prolonged serum half-life, shows study.
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
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Tremfya® shows promise in Phase III psoriatic arthritis study
Tremfya inhibited radiographic progression and provided durable improvements in symptoms of axial involvement in psoriatic arthritis patients.
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Stelara® shows promise to treat gut diseases in new analyses
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
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SEC-MS: a “powerful tool” for ADC analysis, find researchers
Research shows size exclusion chromatography (SEC) with mass spectrometry (MS) enables the simple, quick and reliable analysis of antibody-drug conjugates (ADCs).
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Imfinzi™ improves overall survival in biliary tract cancer (BTC) patients
Imfinzi plus chemotherapy is the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care for BTC.
