FDA approves first Stelara biosimilar, Wezlana
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
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Antibiotics ‘no longer effective’ for childhood infections, finds study
Australian-led study highlights ‘alarmingly high’ rates of resistance to commonly-prescribed antibiotics in the Asia-Pacific region.
European approval for third adapted COVID-19 vaccine
The European Commission has authorised the first protein-based adapted vaccine for COVID-19.
Could centrifugal bioreactor accelerate cell-therapy manufacturing?
Researchers from Washington State University have developed a centrifugal bioreactor, which they claim can manufacture T cells 30 percent faster than current technologies.
Alfasigma to acquire Jyseleca from Galapagos
31 October 2023 | By
Italy-based Alfasigma has agreed to acquire the Jyseleca (filgotinib) business from Belgian biotech Galapagos for €170 million.
Weekly injection shows promise for type 1 diabetes
Once-weekly icodec injections showed non inferiority to once-daily injections of degludec in a Phase III clinical trial.
Metformin helps manage weight gain side effect of SGAs
US study shows metformin has ‘modest but significant effect’ in helping to reduce weight gain in youths taking SGA medications to treat bipolar disorder.
Gene therapy for rare muscular dystrophy presents preliminary promise
Initial clinical results for a gene therapy being evaluated in limb-girdle muscular dystrophy has shown evidence of transgene expression in the three-month muscle biopsy.
Sustainable biosimilar competition in Europe: can it be achieved?
The Biosimilar Medicines Group has reflected on a new report by IQVIA that outlines factors for achieving sustainable levels of biosimilar competition in Europe.
New Bill could enhance UK clinical trial regulation
According to a report on policy development in the UK, the Future Clinical Trials Bill will mandate transparent trial registration and facilitate quicker regulatory approval.
UK Clinical Trial Application submitted for amyloid-targeting drug
The Clinical Trial Application sent to the MHRA is for a combination drug with the potential to become a cost-effective treatment against early Alzheimer’s disease.
NICE recommends first Parkinson’s treatment
A new, easy-to-use treatment option for advanced Parkinson’s could benefit around 900 adult patients on the NHS, according to National Institute for Health and Care Excellence (NICE) final draft guidance.
SGS ISL marks two-year anniversary
We are thrilled to celebrate two years since International Services Laboratory (ISL) in Ringaskiddy, Cork, Ireland, became part of the SGS network.
FDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
Guidance on machine learning-enabled medical devices published
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
