05/12/2017 — MOUNT LAUREL, N.J. — (BUSINESS WIRE) PMC Group France, a wholly owned subsidiary of PMC Group International Inc., which is an independent arm of PMC Group Inc., announced […]
Revolutionary technology will accelerate utility of gene mapping, biomarker discovery, tumor profiling, and liquid biopsy analysis 03/08/2017 — ANN ARBOR, Mich. — (BUSINESS WIRE) Swift Biosciences, a leading provider of […]
Interim study findings further support safety, efficacy and tolerability in squamous and elderly patients with advanced NSCLC, consistent with results previously seen in the pivotal Phase III trial 06/12/2016 — […]
On the side lines of the 71st UN General Assembly in New York 19/09/2016 — NEW YORK — (BUSINESS WIRE) The NCD Alliance yesterday evening announced that the second Global […]
First Phase III trial evaluating the addition of an immune checkpoint inhibitor to standard of care in first-line ovarian cancer New investigational regimen will evaluate avelumab in extending progression-free survival […]
First pivotal study for Merck and Pfizer’s investigational anti-PD-L1 antibody avelumab shows clinically meaningful tumor responses in pre-treated metastatic Merkel cell carcinoma (MCC) International, multicenter Phase II study results in […]
14 avelumab abstracts at ASCO 2016 highlight significant progress being made by the collaboration between Merck and Pfizer Two oral presentations: avelumab investigated as a second-line treatment for metastatic Merkel […]
Collaboration will focus on a Phase I/Ib clinical trial expected to begin in the second half of 2016 03/03/2016 — DARMSTADT, Germany & NEW YORK & BOSTON — (BUSINESS WIRE) […]
Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This marks the second regulatory approval for Samsung Bioepis in Korea. The MFDS approved in September 2015 Samsung Bioepis’ BRENZYS®, a biosimilar version of Enbrel® (etanercept), also known as SB4.
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission (EC) has approved the reconciliation of indications for nivolumab under the Opdivo European Marketing Authorization Application (MAA). In compliance with European Commission regulations, Bristol-Myers Squibb previously submitted two separate MAAs to the European Medicines Agency (EMA); one under the name Opdivo for the treatment of unresectable or metastatic melanoma in adults, and one under the name Nivolumab BMS for the treatment of locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) after prior chemotherapy. An application to reconcile these two indications was then submitted under the Opdivo brand name.