Clinical Trials
Evidera to Join PPD, Creating the Global Leader in Real-World Research
09/08/2016 — WILMINGTON, N.C. — (BUSINESS WIRE) Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), today announced it has entered into an agreement to acquire Evidera, […]
European Commission Grants Marketing Authorisation for MSD’s ZEPATIER™ (elbasvir/grazoprevir) for the Treatment of Chronic Hepatitis C Infection
In Phase 3 Clinical Trials, ZEPATIER Achieved High Cure (SVR) Rates Across Diverse Populations of Patients With Chronic Hepatitis C, Including Those With Compensated Cirrhosis, Renal Impairment or on Opioid […]
Merck and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer
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 […]
ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma
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 […]
Merck and Pfizer to Present Avelumab Data in Seven Different Cancers at ASCO Annual Meeting
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 […]
MedDay Secures €34 Million ($38.5M) New Funding
Edmond de Rothschild Investment Partners led the Series B financing alongside existing investors Sofinnova Partners and InnoBio. Large Venture also participated in the operation. Funds will drive a confirmatory phase […]
Samsung Bioepis’ Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union
Samsung Bioepis’ Flixabi® receives positive opinion from the Committee for Medicinal Products for Human Use, meets the European Medicines Agency’s requirements on the quality, efficacy and safety of biosimilars Flixabi® […]
Merck, Pfizer and Verastem Announce Combination Trial of Avelumab and VS-6063 in Ovarian Cancer
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 Receives Positive CHMP Opinion for the First Etanercept Biosimilar in the European Union
Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali® – a biosimilar version of Enbrel® (etanercept), previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. This marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar.