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First pill for desmoid tumours approved
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
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Regulation & Legislation
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Application note: Role of in-house isolates in pharmaceutical quality control
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
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First treatment recommended for infants with Wolman Disease
Alexion’s intravenous enzyme replacement therapy has been recommended for the ultra-rare disease by the National Institute for Health and Care Excellence (NICE).
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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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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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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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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.
