Researchers at Stanford University School of Medicine with the National Cancer Institute (NCI) have identified another cancer-surface molecule, CD22, and begun trials on B-cell acute lymphoblastic leukemia (ALL) patients using an immuno-oncology approach similar to CAR-T. In the Phase I trial, 15 of the 21 patients who had previously relapsed or did not respond to anti-CD19 CAR-T, were treated with an anti-CD22 CAR-T therapy. Ten of the 15 patients had already received treatment for CD19-targeted treatment.
Peptidream Inc. has scored another billion dollar-plus agreement to develop peptide-based therapies aimed at the treatment multiple disease targets.
The U.S. Food and Drug Administration(FDA) approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration(FDA) has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). The approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received SUTENT compared to placebo in the adjuvant setting.
The U.S. Food and Drug Administration(FDA) today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Novartis is blazing ahead with its bid to take its new CAR-T therapy, Kymriah, into new realms with a double-pronged approval application in Europe.
As NousCom CEO Alfredo Nicosia likes to say, the Basel-based biotech is a relative fledgling at 2-years of age. But the core research team there has been working together for quite a few years.
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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