In a notable advancement in the oncology sector, BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a globally recognized oncology company, has received approval from the U.S. Food and Drug Administration (FDA) for TEVIMBRA (tislelizumab-jsgr). This approval marks a significant milestone for TEVIMBRA as a monotherapy in the treatment of adult patients with unresectable or […]
In a significant development for patients with relapsed or refractory follicular lymphoma, BeiGene, Ltd. has announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA (zanubrutinib). This marks the treatment as the first and only BTK inhibitor approved for adult patients in the U.S. who have undergone two or more lines […]
BeiGene, a global biotechnology firm, has revealed that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for tislelizumab. This treatment is intended for adult patients suffering from unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone platinum-based chemotherapy. “Tislelizumab is the first […]
BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Brukinsa FDA approval is backed by the findings of two global phase 3 clinical trials wherein Brukinsa showed superior efficacy and […]
Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The Chinese breakthrough therapy designation for sotorasib is for the treatment of patients having KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer […]
BeiGene said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of pamiparib for the treatment of certain ovarian cancer patients. Pamiparib is an investigational inhibitor of PARP1 and PARP2 and its NDA is for patients having deleterious or suspected deleterious germline […]
US biopharma company Amgen has signed an all-cash deal to acquire a 20.5% stake in Chinese biotech company BeiGene for about $2.7 billion, as per the latest pharma acquisition news. The Beijing-based BeiGene is a research-based, oncology-focused biotechnology company, which is engaged in developing molecularly targeted and immuno-oncology drug candidates for cancer treatment. The transaction […]