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 mesenchymal stromal cell therapy
By Clara Rodriguez Fernandez
nChroma Bio formed by merging genetic medicine companies
By Helen Albert
Cell and gene therapy access model launches in US
By Helen Albert
Clinical development
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SpliceBio gets FDA green light to start Phase 1/2 trial for inherited eye disease gene therapy
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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Teva and Sanofi’s IBD drug hits Phase 2 targets
By Helen Albert
Orexo and Abera collaborate to develop nasal powder vaccines
By Larissa Warneck-Silvestrin
GSK and Muna Therapeutics partner to develop new treatments for Alzheimer’s
By Clara Rodriguez Fernandez
Weight loss drugs
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Antag Therapeutics raises $84 million to advance its weight loss drug into the clinic
By Larissa Warneck-Silvestrin
Amgen announces positive Phase 2 results for its GLP-1-GIP weight loss drug
By Larissa Warneck-Silvestrin
