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Dostarlimab combination facilitates promising lung cancer survival
The largest head-to-head trial of PD-1 inhibitors for non-squamous non-small cell lung cancer suggested dostarlimab with chemo aided survival.
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$5 billion bispecific antibody pharma collaboration
As part of a $5 billion collaboration, Akeso Inc. will out-license its PD-1-based bispecific antibody ivonescimab to Summit Therapeutics.
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Comirnaty® authorised for patients six months to four years
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
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Jardiance® improves blood sugar control in type 2 diabetes
A Phase III trial showed Jardiance® is the first SGLT2 inhibitor to significantly reduce average blood sugar in type 2 diabetics aged 10-17 compared to placebo.
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France’s ATU reform: early access remains possible, but not all diseases are equal
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
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EMA accepts marketing application for ALS treatment
The EMA has accepted the marketing authorisation application for tofersen, which could be the first treatment for a rare genetic cause of ALS.
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Pluvicto™ offers survival benefits for metastatic prostate cancer
The PSMA-targeted radioligand is first to significantly improve radiographic progression-free survival for PSMA–positive metastatic castration-resistant prostate cancer, shows study.
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FDA approves Rezlidhia™ for leukaemia
Rezlidhia™ has been approved for adults with mIDH1 relapsed/refractory acute myeloid leukaemia by the US Food and Drug Administration (FDA).
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mRNA non-vaccine therapeutics to generate $2 billion by 2028
Driven by the approval of pipeline agents, mRNA non-vaccine therapeutics are set to reach $2 billion in sales by 2028, says GlobalData.
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Could acoziborole eliminate sleeping sickness in Africa?
Acoziborole showed significant success in clinical studies, suggesting it could simplify treatment and help eradicate sleeping sickness.
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First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
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First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
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NEJM publishes lecanemab Alzheimer’s study results
Full study results of Eisai’s Phase III Alzheimer's study suggest lecanemab could slow disease progression.
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Radiation with immunotherapy increases lung cancer survival
Phase I study analysis determined immunotherapy with radiation is more effective than radiotherapy alone for metastatic non-small cell lung cancer.
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First adaptive clinical trial for flu
A £2.9 million trial, the first adaptive platform trial studying flu treatments, could reduce serious illness in patients.
