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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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.
AbbVie agrees $10 billion oncology acquisition
Under its proposed acquisition of ImmunoGen, AbbVie will gain rights to ELAHERE®, the first antibody-drug conjugate (ADC) approved in ovarian cancer.
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.
Acquisition deal to back European biosimilars market
Following the acquisition from Viatris, Biocon Biologics and its partners state that they will commercialise biosimilar products in 31 European countries.
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.
Pharma unites to secure renewable energy in key manufacturing markets
The new industry collaboration aims to help decarbonise the global supply chain by focusing on the energy-intensive pharmaceutical manufacturing that takes place in China and India.
Cold storage market to value $383bn by 2032
The combination of tech innovation, automation, and sustainability is reshaping the landscape of cold storage solutions, research says.
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).
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.
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).
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.
Novo Nordisk to expand French production facilities
Using an investment of more than €2.1 billion, a planned expansion at one of Novo Nordisk’s strategic production sites will include additions such as aseptic production and the extension of its Quality Control Laboratory.
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.
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.
