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Novartis secures first-of-a-kind haematology approval
A novel Factor B inhibitor of the immune system's complement pathway has been approved for paroxysmal nocturnal haemoglobinuria (PNH).
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Drug Safety
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Phase III data for novel telomerase inhibitor released
Currently, imetelstat is being reviewed by the FDA and EMA for the treatment of transfusion-dependent anaemia in adults with lower risk MDS.
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Pharmaceutical excipients market to witness expansion
According to research, increased in R&D investment for developing novel excipients and greater emphasis on patient-centric formulations are key drivers for the pharmaceutical excipients market.
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Novel generalised myasthenia gravis treatment approved
A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.
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Innovative technologies facilitate novel contamination-detection method
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
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Ferring reveals long-term data for cancer gene therapy
New data from a Phase III gene therapy trial has demonstrated a 90 percent three-year overall survival rate for its participants with a high-risk bladder cancer.
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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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Could stem cell therapy stabilise MS progression?
Positive findings from a first-in-human trial means that an advanced cell therapy for progressive multiple sclerosis will be evaluated in Phase II.
whitepaper
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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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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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.
