Clovis Oncology Inc. announced that the European Commission approved the use of Rubraca (rucaparib) for a second indication: as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Amgen announced that the European Commission approved an expanded indication for Blincyto monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.
Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for U.S. FDA Review
Australia's Therapeutic Goods Administration, Biologics License Application (BLA), Biopharma, Biosimilars, Blockbusters, Clinical Trials, European Commission, FDA, FDA/Regulatory, Health CanadaSamsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).
Pfizer Inc. announced that the European Commission approved Xeljanz (tofacitinib citrate) 10 mg twice daily for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
The European Commission approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.
The European Commission approved Pfizer’s Xeljanz in combination with methotrexate for treating active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
The European Commission granted Marketing Authorization for Gilead Sciences Inc.’s Biktarvy as a once-daily single tablet regimen for the treatment of HIV-1 infection.
Amgen today announced that the European Commission approved a new indication for Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Clovis Oncology Inc. today announced that the European Commission authorized Rubraca (rucaparib) as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.