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Survey reports on falsification of medical devices
1 December 2023 | By
Falsification of medical devices exists in Council of Europe member states, but there are few investigations and prosecutions, a new survey finds.
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Regulation & Legislation
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Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
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Whitepaper: The value and benefits of rapid mold detection in the pharmaceutical industry
Address the importance of accurate microbial identifications and proper contamination control for effective mold remediation.
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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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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.
