News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Trends
Antibody-drug conjugates
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Alentis raises $181 million to advance ADCs to the clinic
By Larissa Warneck-Silvestrin
Synaffix and BigHat Biosciences collaborate to develop AI-designed ADC
By Larissa Warneck-Silvestrin
Promotional features
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An Experienced CDMO Can Be a Differentiator in the Rapidly Growing Biologics Market
Paid for and content provided by Scorpius BioManufacturing
Is GMP grade good enough? What mRNA manufacturers need to know when buying raw materials
Paid for and in partnership with Thermo Fisher Scientific - Biosciences
Continuous bioprocessing set to revolutionize cGMP manufacturing of biologics
Paid for and content provided by Just – Evotec Biologics
AAVs – liquid treasure handled safely
Paid for and content provided by Single Use Support
Biosimilars
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EMA accepts Alvotech and Advanz Pharma’s Marketing Authorization Application for biosimilar of J&J’s Simponi
By Larissa Warneck-Silvestrin
Innovations in mass spectrometry accelerate the shift toward precision medicine
By Clara Rodriguez Fernandez
MinervaX and Wacker Biotech partner to scale up GBS vaccine production
By Larissa Warneck-Sivestrin
EU approves Regeneron’s bispecific antibody following US rejection
By Jonathan Smith
Cell & gene therapies
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FDA approves first-ever gene therapy to be directly administered to the brain
By Clara Rodriguez Fernandez
Clinical development
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FDA removes clinical hold on Novavax’s COVID-19-influenza combo vaccine
By Larissa Warneck-Silvestrin
Emerging markets
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FDA approves targeted therapy for gastric cancer and its companion diagnostic
By Clara Rodriguez Fernandez
Pipelines
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Resolution Therapeutics scores £63.5 million Series B
By Helen Albert
Eli Lilly expands manufacturing facilities in Ireland with $1.8bn investment
By Clara Rodriguez Fernandez
Eli Lilly reports positive phase 3 results for a weekly insulin formulation
By Clara Rodriguez Ferndandez
Weight loss drugs
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Novo Nordisk signs $285 million deal for a once-monthly GLP-1 receptor agonist
By Clara Rodriguez Fernandez
Novo Nordisk’s semaglutide shows additional cardiovascular benefits in overweight patients
By Clara Rodriguez Fernandez