BeiGene
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An independent data monitoring board found that BeiGene’s ociperlimab was unlikely to significantly boost overall survival in patients with untreated NSCLC.
The FDA’s Oncology Drugs Advisory Committee voted near-unanimously that the benefits of PD-1 inhibitors like Keytruda and Opdivo in PD-L1 low patients do not outweigh the risks.
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression.
After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma.
BeiGene’s Brukinsa becomes the first BTK inhibitor approved for follicular lymphoma, the most common type of low-grade non-Hodgkin lymphoma.
The biotech company has bought the global rights to an investigational oral CDK2 inhibitor from Ensem Therapeutics in a licensing agreement valued at up to $1.33 billion if all milestones are met.
The abstracts, made available Tuesday ahead of the European Society for Medical Oncology Congress 2023, show strong efficacy data from some promising non-small cell lung cancer treatments.
ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.
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