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Developing terminal sterilisation processes for oligonucleotide drugs
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
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Biogen
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Eisai submits MAA for lecanemab in Europe
A Marketing Authorisation Application for lecanemab to treat Alzheimer's has been submitted to the European Medicines Agency.
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Potential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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Converging knowledge and technology to transform neuromuscular disease treatment
With the emergence of innovative therapeutic technologies and progress in the genetic understanding of diseases, Biogen’s Toby Ferguson explains why it is a promising time for the development of therapies for neuromuscular conditions such as amyotrophic lateral sclerosis (ALS).
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Oligonucleotide synthesis market to reach $16.7 billion by 2027
Ongoing clinical trials for oligonucleotide-based therapies will propel the oligonucleotide synthesis market to reach $16.7 billion by 2027, states a new report.
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EMA accepts marketing application for ALS treatment
The EMA has accepted the marketing authorisation application for tofersen, which could be the first treatment for a rare genetic cause of ALS.
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Full data set for new buffer stock blending system freely available
NIIMBL and BioPhorum reveal open-access design models for a new buffer stock blending system that could help reduce bottlenecks in biomanufacturing plants.
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Zuranolone shows promise as episodic treatment for depression
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
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Formulation development outsourcing market to be worth over $60bn by 2030
Market research suggests the global formulation development outsourcing market will significantly expand in coming years, owing to disease burden and R&D expenditure.
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Litifilimab reduces skin disease activity in CLE trial
Phase II results suggest litifilimab safely and effectively reduces skin disease activity in cutaneous lupus erythematosus (CLE) patients.
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Samsung Bioepis fully acquired by Samsung Biologics
After first payment of $1bn to Biogen, Samsung Biologics has now fully acquired Samsung Bioepis.
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Is Aduhelm® of benefit to Alzheimer’s patients long-term?
New data shows that patients taking Aduhelm® (aducanumab-avwa) had significant reductions in tau and amyloid beta after nearly 2.5 years.
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Pistoia Alliance launches Women in STEM leadership pilot
A new collaborative initiative involving 15 large pharma companies will support diversity in executive roles and cross-company leadership skills development.
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Many hands make light work: why the new Bespoke Gene Therapy Consortium is a godsend for ambitious biopharma teams
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
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European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
