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CHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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tislelizumab
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Phase III trial shows tislelizumab improves outcomes for liver cancer patients
Phase III trial results indicate BeiGene’s tislelizumab improved overall survival in patients with unresectable hepatocellular carcinoma (HCC) versus sorafenib.
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Novartis submit BLA for tislelizumab for oesophageal cancer treatment
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
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Tislelizumab reduces risk of death by 30 percent in oesophageal cancer trial
In a Phase III trial, Novartis’ investigational checkpoint inhibitor tislelizumab improved overall survival in patients with oesophageal squamous cell carcinoma.
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First company awarded market authorisation under new Chinese drug law
The mAb tislelizumab has been granted approval from Chinese authorities, making Boehringer Ingelheim Biopharmaceuticals the first MAH under the new system.
