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Long COVID study expanded across Europe
If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.
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Regs & Legs
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Vertex scores European cystic fibrosis medicine approval
Following a milestone approval by the European Commission in July 2023, Vertex Pharmaceuticals has been granted a label expansion for its cystic fibrosis medicine KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) with ivacaftor.
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EC approves first-line ovarian cancer treatment
A Phase III trial evaluating rucaparib demonstrated that it significantly improved progression-free survival in women with advanced ovarian cancer, regardless of their BRCA mutation status.
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BRUKINSA® granted significant EU approval in follicular lymphoma
The first and only Bruton’s tyrosine kinase (BTK) inhibitor approved for follicular lymphoma in the EU, now has the broadest label of any medicine in its class globally.
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EU pharma legislation key in tackling AMR
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the EU general pharmaceutical legislation has potential to shape the future of EU actions against antimicrobial resistance (AMR).
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Product hub: Rapid mold detection in as little as one day
Quick to spread and difficult to detect, molds can compromise a facility in the time it takes to confirm their presence. The RMBNucleusTM Mold Alarm signals at the first sign of mold detection.
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EC approves lebrikizumab for atopic dermatitis
Monoclonal antibody, lebrikizumab, is approved in Europe for treatment of adults and adolescents with moderate-to-severe atopic dermatitis.
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Regional inequalities threatening Europe’s biosimilars market
A new report reveals that low biosimilar adoption in certain European regions is impacting biologic medicine access for patients.
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First CRISPR-based gene-editing therapy authorised
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a world-first regulatory authorisation to a medicine based on Nobel Prize-winning technology.
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CHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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Guide to Outsourcing 2023
In this Guide to Outsourcing, EPR explores trends in outsourcing of regulatory activities, Quotient Sciences discusses how to accelerate drug development and Associates of Cape Cod International looks at sustainable bacterial endotoxin testing.
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First chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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Formulation In-Depth Focus 2023
This in-depth focus features articles on paediatric formulations as well as the role of definitive screening design in improving biopharmaceutical development.
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QA/QC & Microbiology In-Depth Focus 2023
This microbiology in-depth focus, explores sterility and bioburden testing considerations for cell and gene therapies.
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Scientific journal: Complete your clinical research 6 to 9 weeks faster
Discover how completing your trials in Canada can accelerate your early phase clinical research by six to nine weeks compared to an IND submission.
