Oncology
Personalis, Inc. Announces Collaboration With Merck KGaA, Darmstadt, Germany, to Identify and Develop Novel Biomarkers for Cancer Therapies
19/11/2019 — MENLO PARK, Calif. — (BUSINESS WIRE) Personalis, Inc. (Nasdaq:PSNL), a leader in advanced genomics for cancer, today announced a collaboration with Merck KGaA, Darmstadt, Germany, a leading science […]
Personalis, Inc. Enters Into Research Agreement With Invectys to Provide Comprehensive Tumor Immunogenomics Profiling for Clinical Trial
09/09/2019 — MENLO PARK, Calif. & PARIS — (BUSINESS WIRE) Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced that it has entered into a research […]
Frank Schestag, PhD, Joins Proteintech as Commercial Director in Europe
10/07/2019 — ROSEMONT, Ill. — (BUSINESS WIRE) Proteintech, the benchmark in antibodies and proteins, welcomes Frank Schestag, PhD, as Commercial Director. He will be providing leadership to the sales and […]
Quanterix Announces Agreement to Acquire UmanDiagnostics, World’s Leading Neurofilament Light (Nf-L) Antibody Supplier
Positions Quanterix to capitalize on significant growth opportunities with Nf-L applications in Alzheimer’s Disease, Multiple Sclerosis, and other neurodegenerative conditions Provides expected 200 bps of annualized company gross margin improvement, […]
Asuragen to Present at 2019 European Society of Human Genetics (ESHG) Conference
Corporate satellite meeting and numerous scientific posters feature new Asuragen products 11/06/2019 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing […]
Aptorum Group Establishes Smart Pharma to Focus on Computational Repurposed Drug Discovery for Orphan and Unmet Diseases
24/04/2019 — SINGAPORE — (BUSINESS WIRE) Aptorum Group Limited (Nasdaq: APM) today announced the establishment of a new subsidiary group, Smart Pharma (“SmartP”), which operates its novel computational repurposed drug […]
Newly-Formed Arvelle Therapeutics Acquires Exclusive Rights from SK Biopharmaceuticals to Develop and Commercialize Cenobamate in Europe
Arvelle Therapeutics GmbH to provide SK Biopharmaceuticals an upfront payment of $100 million with future milestone potential of up to $430 million A new CNS-focused company, Arvelle received one of […]
Powering Precision Health Announces Inaugural European Summit in Amsterdam December 12-13, 2018
Thought leaders convene to discuss research advances disrupting healthcare, including breakthroughs with blood-based Neurofilament light (NfL) in neurodegenerative diseases 05/12/2018 — LEXINGTON, Mass. & AMSTERDAM — (BUSINESS WIRE) Powering Precision […]
Asuragen Launches Assay to Aid in the Diagnosis of Myotonic Dystrophy Type I (DM1)
The AmplideX® DM1 Dx Kit is now available in countries accepting the CE mark 04/12/2018 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products […]
CPDC and McMaster Nuclear Reactor Sign Research Agreement for Production of High Value Medical Isotopes
13/09/2018 — HAMILTON, Ontario — (BUSINESS WIRE) The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, and the McMaster Nuclear […]
Asuragen Expands Oncology Portfolio with CE Marking and Launch of QuantideX® NGS DNA Hotspot 21 Kit
The panel accurately and sensitively detects over 1600 variants of clinical significance 05/09/2018 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc., a molecular diagnostics company delivering high-quality, easy to use […]
Asuragen to Launch the AmplideX® PCR/CE DMPK Kit and Present Growing Genetic Testing Portfolio at 2018 European Society of Human Genetics (ESHG) Conference
The AmplideX DMPK Kit is the first of several new genetics products in 2018 22/05/2018 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc., a molecular diagnostics company delivering high-quality, easy […]
Asuragen to Present at World CB & CDx Europe Summit in London, UK
Roundtable will address CDx development strategies in light of changing European IVD regulations 24/04/2018 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc., a molecular diagnostics company delivering easy to use […]
Asuragen Obtains CE Mark of QuantideX® qPCR BCR-ABL Kits on Roche Diagnostics cobas z 480 Analyzer
17/01/2018 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc., a global molecular diagnostics product company changing the way patients are treated in genetics and oncology by bringing complex molecular tests […]
Mevion Receives 510(k) Clearance for HYPERSCAN Pencil Beam Scanning
03/01/2018 — LITTLETON, Mass. — (BUSINESS WIRE) Mevion Medical Systems has received FDA 510(k) clearance for the MEVION S250i Proton Therapy System® including HYPERSCAN™ pencil beam scanning (PBS) technology. HYPERSCAN […]
PMC Group International Announces Acquisition of Pharma Company in France
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 […]
Swift Biosciences Announces New Industry-Leading Indexed Adapters for Sequencing Larger Numbers of Samples in a Single Run
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 […]
ABOUND Data Presented at the World Conference on Lung Cancer Further Explores Safety and Efficacy of ABRAXANE® for Challenging Patient Populations
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 — […]
Second Global NCD Alliance Forum to be Held in Sharjah, UAE in December 2017
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 […]
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 […]
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’ RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea
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.
European Commission Approves Reconciliation of Indications for nivolumab Under the Opdivo® European Marketing Authorization Application
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.
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.