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.
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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).
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.
Boehringer Ingelheim to advance bacterial cancer therapeutics
Through a new acquisition, Boehringer Ingelheim will have rights to a platform that enables the design of immuno-oncology combination therapies in one single agent.
Oligonucleotide manufacturing centre to open in Scotland
A key goal of the Centre for Process Innovation’s (CPI) new Oligonucleotide Manufacturing Innovation Centre of Excellence in Scotland, is to plug the current gap between supply and demand for these innovative medicines.
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.
Fully instrumented 3D printed small-scale bioreactor developed
To support upstream bioprocess development, a study has demonstrated real-time monitoring of the growth phase in a 3D printed, single-use bioreactor.
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.
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.
Eli Lilly reveals plans for new high-tech parenteral manufacturing site
Once operational in 2027, Eli Lilly’s new $2.5 billion German manufacturing site will play a vital role in supporting the company’s incretin supply.
EU pharma legislation key in tackling AMR
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the EU general pharmaceutical legislation has potential to shape the future of EU actions against antimicrobial resistance (AMR).
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.
