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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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Clinical Development
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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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New Amgen immunotherapy could treat common solid tumour
With demonstrated benefit in anti-tumour activity and overall survival in patients with small cell lung cancer, Tarlatamab could provide a new third-line option, a Phase II study suggests.
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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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GSK propels its progress to Net Zero
The lower carbon propellant has the potential to reduce greenhouse gas emissions from Ventolin (salbutamol) inhaler by approximately 90 percent, GSK reports.
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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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Trial for novel CGRP migraine medicine gleans positive results
The first pill designed to directly block calcitonin gene-related peptide (CGRP), a protein released during a migraine attack, has demonstrated positive evidence in AbbVie’s trial investigating its efficacy in the prodrome phase.
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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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Advancing clinical development in haematology oncology
Newly appointed Vice President of Medical Affairs, Europe at BeiGene, Dr Jan-Henrik Terwey, provides exclusive insight on clinical development in the haematology/oncology space, and highlights significant data for its BCL-2 inhibitor, sonrotoclax.
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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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Could GSK myelofibrosis treatment gain EU-first approval?
If approved, momelotinib will be the first treatment in the EU indicated for myelofibrosis patients with moderate to severe anaemia.
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Novel siRNA therapeutic could lower cardiovascular disease risk
A Phase II trial for the small interfering RNA (siRNA) therapeutic lepodisiran is currently underway, assessing its ability to reduce lipoprotein(a) levels.
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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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Targeted therapy for hard-to-treat leukaemia subtype approved in EU
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
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Developing a first-in-class small molecule drug for inflammatory disease
In this exclusive Q&A, Dr Jenna Brager, Executive Vice President of Drug Development for MyMD Pharmaceuticals® explains to EPR why its oral small molecule drug could transform how TNF-α based diseases are treated.
