Tag Archives: PD-1 inhibitor

July, 2017

6 July
FDA Halts Three Multiple Myeloma Studies Evaluating Keytruda After Deaths

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer multiple myeloma. This decision …
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6 July
Celgene Enters Cancer Immunotherapy Deal with BeiGene for its Investigational PD-1 Inhibitor

SUMMIT, N.J. & BEIJING–(BUSINESS WIRE)– Celgene Corporation (NASDAQ:CELG) and BeiGene, Ltd. (NASDAQ:BGNE) entered into a strategic collaboration to develop and commercialize BeiGene’s investigational anti-programmed cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with solid tumor cancers in the United States, Europe, Japan and rest of world outside Asia. BeiGene will retain exclusive rights for the development and commercialization of BGB-A317 for hematological malignancies globally …
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19 May
FDA Approves Merck’s Keytruda for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In …
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8 May
Regeneron and Inovio Enter Agreement for Glioblastoma Combination Therapy

TARRYTOWN, N.Y. and PLYMOUTH MEETING, Pa., May 8, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced a clinical study agreement for a Phase 1b/2a immuno-oncology trial. The study will be conducted by Inovio in patients with newly-diagnosed glioblastoma multiforme (GBM) and will …
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3 February
FDA Accepts Two sBLA’s for Merck’s Keytruda

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a …
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18 May
FDA Grants Accelerated Approval to BMS’ Opdivo for Classical Hodgkin Lymphoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo®(nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.1 This accelerated approval is based on …
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