EMD Serono
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02370
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Website: https://www.emdserono.com/us-en
226 articles with EMD Serono
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EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study
3/13/2020
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced an update from the Phase III JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN)
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The companies jointly announced that their Phase III JAVELIN Head and Neck 100 trial of Bavencio (avelumab) with chemoradiotherapy for untreated locally advanced squamous cell carcinoma of the head and neck was unlikely to hit the primary endpoint.
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These prices refer to the company’s list price. Most patients will not pay that price because of various forms of health insurance or patient assistance programs.
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EMD Serono Receives Positive Recommendation for MAVENCLAD® (cladribine tablets) for the treatment of Relapsing-Remitting Multiple Sclerosis from the Institut national d'excellence en santé et en services sociaux (INESSS)
2/6/2020
This decision brings PrMAVENCLAD® (cladribine tablets) closer to broader access for eligible patients living with Relapsing-Remitting Multiple Sclerosis in the province of Quebec
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Clinical Catch-Up: January 6-10, 2020
1/13/2020
The first full business week of the new year began with plenty of clinical trial news. Here’s a look. -
BAVENCIO Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
1/6/2020
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival (OS) at the planned interim analysis.
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“Bavencio is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
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EMD Serono and the pan-Canadian Pharmaceutical Alliance Complete Negotiations for MAVENCLAD® (cladribine tablets) for the treatment of Relapsing-Remitting Multiple Sclerosis
12/10/2019
This an important next step to ensure broader access to PrMAVENCLAD® for eligible Canadians living with Relapsing-Remitting Multiple Sclerosis
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EMD Serono and Pfizer Provide Update on Phase III JAVELIN Gastric 100 Trial
11/8/2019
EMD Serono and Pfizer Inc. announced topline results of the Phase III JAVELIN Gastric 100 study evaluating avelumab as first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction cancer versus continuation of chemotherapy or best supportive care.
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European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma
10/28/2019
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
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Exploratory Analysis Reports Efficacy and Safety of BAVENCIO® (avelumab) Over Three Years in Previously Treated Metastatic Merkel Cell Carcinoma
10/22/2019
Data represent the longest prospective follow-up for an immune checkpoint inhibitor in patients with mMCC,1 a rare and aggressive type of skin cancer
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EMD Serono Announces JAMA Publication of Phase II Results of Sprifermin for Osteoarthritis Structure Modification
10/8/2019
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that results from FORWARD, a five-year, multicenter Phase II study of sprifermin, a recombinant human fibroblast growth factor-18, in patients with symptomatic radiographic knee osteoarthritis (OA) were published online in the Journal of the American Medical Association (JAMA).
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New Data for BAVENCIO® (avelumab) for Advanced Cancers to Be Presented at ESMO 2019
9/27/2019
EMD Serono and Pfizer Inc. announced the presentation of multiple analyses from the JAVELIN clinical development program assessing BAVENCIO® alone or as part of combination regimens for the treatment of advanced cancers, including renal cell carcinoma, metastatic Merkel cell carcinoma and some other solid tumors at the European Society for Medical Oncology Congress 2019 in Barcelona, Spain.
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CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma
9/20/2019
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC)
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EMD Serono Initiates Pivotal Phase III Program for Investigational Evobrutinib in Relapsing Multiple Sclerosis
9/10/2019
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the initiation of two global pivotal Phase III trials (EVOLUTION RMS 1 and 2) studying the efficacy and safety of evobrutinib, an oral, highly selective Bruton's Tyrosine Kinase (BTK) inhibitor in adult patients with relapsing multiple sclerosis (RMS).
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EMD Serono to Showcase Scientific Leadership at ECTRIMS 2019 with New Data Across Multiple Sclerosis Medicines
8/28/2019
Company to present 39 abstracts, including data on MAVENCLAD® tablets, Rebif® and investigational evobrutinib
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Nebula Genomics Signs Agreement for Pilot Project with EMD Serono
6/11/2019
Agreement will grant EMD Serono access to genomic data for drug research
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EMD Serono to Present Data at CMSC Annual Meeting Showcasing Breadth of MS Portfolio and Commitment to Understanding How MS Impacts Patients
5/28/2019
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, will present data from its multiple sclerosis (MS) portfolio at the Consortium of Multiple Sclerosis Centers (CMSC) 2019 Annual Meeting, taking place May 28 – June 1, 2019 in Seattle, WA.
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MAVENCLAD® (Cladribine) Tablets Now Covered by Express Scripts
4/8/2019
EMD Serono, Inc. today announced that Express Scripts is covering on its formulary the oral multiple sclerosis (MS) therapy, MAVENCLAD® (cladribine) tablets, which was approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019.
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FDA Approves MAVENCLAD® (Cladribine) Tablets as First and Only Short-Course Oral Treatment for Relapsing-Remitting and Active Secondary Progressive Multiple Sclerosis
3/29/2019
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved MAVENCLAD® (cladribine) tablets for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS)