clinical data News
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Arterius team up with Prof Patrick Serruys at EuroPCR 2016 (Paris)
Arterius are delighted to be working with Professor Patrick Serruys of Erasmus Medical Centre (Netherlands) and Cardialysis. Professor Serruys presented a talk entitled “Bench testing evaluation of a novel fully drug-eluting BRS” at EuroPCR on 19th May 2016. The talk was part of the “BRS: Evolving Technologies and Applications” session, also featuring presentations ...
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The Value of Deep Phenotyping in Genomic Research
Uncovering associations between a disease and relevant genomic variants requires both detailed sequence data and detailed clinical data. Join Genuity Science Principal Scientist Anthony Ryan, PhD as he discusses the importance and value of deep phenotyping when looking for genomic associations to disease. In this video he covers: What is meant by ‘deep’ phenotyping. Why ...
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PhysioAssist at 10th edition of “Journées du GREPI”!
We are happy to have participated in the 10th edition of “Journées du GREPI”! Many interesting exchanges and a very good participation in the integrated workshop where the place of bronchial drainage in the improvement of the management of infectious exacerbations of bronchiectasis could be demonstrated. Program: On 24/11 from 16:00 to 17:30, Workshop “Infectious ...
By PhysioAssist
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2nd PhD student appointed to the Toxicity Atlas project
We are very happy to welcome Ghislaine Deutsch as the second PhD student working on the Toxicity Atlas! In the Toxicity Atlas project, Medstoner Silvia Scoarta, VUmc professor Bart Westerman, and their team are researching better ways to treat brain cancer. Quite the task! Ghislaine’s expertise in biology and bio-informatics will make a great contribution to the project by, among other ...
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Cabaletta Bio Reports Clinical Data from the Third Dose Cohort in DesCAARTes™ Trial in Patients with mPV
PHILADELPHIA, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced 28-day clinical data from the third dose cohort using 500 million DSG3-CAART cells in the DesCAARTes™ Phase 1 clinical trial ...
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Amicus Therapeutics Receives Notification of PDUFA Date Extensions for AT-GAA
PHILADELPHIA, May 10, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by 90 days for the Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, the two components of AT-GAA. The revised PDUFA action dates for miglustat and ...
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Kuros Biosciences continues strong commercial roll-out of MagnetOs bone graft
Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...
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Kuros Biosciences continues strong commercial roll-out of MagnetOs bone graft
Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...
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Kuros Biosciences continues strong commercial roll-out of MagnetOs bone graft
Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...
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Miracor announces PiCSO Therapy clinical data to be presented at EuroPCR 2018
Miracor Medical SA today announced that new clinical data of the PiCSO® Impulse System for the treatment of STEMI patients will be presented during the EuroPCR conference in Paris, May 21st - 24th 2018. The PiCSO clinical results will be presented during two different sessions, including a Hotline session: Thursday May 24th @ 11:03 in the "Hotline Coronary Intervention" session, Room ...
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Circassia Announces FDA Approval of Duaklir for Maintenance Treatment of Chronic Obstructive Pulmonary Disease
Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration (FDA) has approved Duaklir® for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Duaklir® is a fixed-dose combination of the long-acting muscarinic ...
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Kala Pharmaceuticals to Present Clinical Data for KPI-012, its Mesenchymal Stem Cell Secretome Product, for the Treatment of PCED at the 2022 ARVO Annual Meeting
ARLINGTON, Mass., May 01, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported clinical data from a Phase 1b trial of KPI-012, its novel, cell-free secretome therapy for the treatment of severe ocular diseases driven ...
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FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval
FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial ...
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Surgentec releases whitepaper featuring A Novel Decortication and Graft Delivery Technique for Minimally Invasive Spine Fusion Surgery
Minimally invasive (MIS) lumbar fusion has become a popular alternative to traditional methods of lumbar decompression and fusion. When compared with the open technique, the minimally invasive approach can result in decreased pain and blood loss as well as a shorter length of hospitalization. However, the narrower working channel in the MIS technique increases the difficulty of decortication and ...
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Genomic Advances in Heart Failure
Heart failure is a significant global health issue. More than half of the people who develop heart failure die within 5 years. Current treatments do not help the largest group of these patients – those with heart failure with preserved ejection fraction (HFpEF) – and have limited effectiveness for those with reduced injection fraction (HFrEF). HFpEF has been called the greatest unmet ...
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TIKOMED granted Orphan Medicinal Drug Designation for ILB® for the treatment of amyotrophic lateral sclerosis by the European Commission
TIKOMED, a Swedish privately-held biopharmaceutical company today announced that the European Commission has granted Orphan Drug Designation to its lead drug candidate ILB® for the treatment of patients with amyotrophic lateral sclerosis (ALS) – a terminal, neurodegenerative disease where most patients die of respiratory muscle weakness in less than three to five years from symptom ...
By TIKOMED AB
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Transgene to Present Updated Positive Preliminary Data from the Phase I Clinical Trials with TG4050 (myvac® platform) at ASCO 2022
Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announces that an abstract reporting preliminary data from the two Phase I trials assessing TG4050, its individualized neoantigen cancer vaccine, has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) annual meeting. The ...
By Transgene
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Altimmune to Present Pemvidutide Clinical Data at Upcoming Global NASH Congress May 27, 2022
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that Dr. Scott Harris, Chief Medical Officer at Altimmune, will give an oral presentation at the 5th Global NASH Congress on May 26-27, 2022, in London, UK. His presentation will provide an overview of pemvidutide, the Company’s novel, investigational GLP-1/glucagon dual receptor agonist under ...
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BillionToOne to present series of single-gene NIPT posters at 2020 ACMG Annual Clinical Genetics Meeting
BillionToOne, a venture-backed precision diagnostics company, is presenting series of posters at 2020 ACMG Annual Clinical Genetics Meeting on its single-gene NIPT technology and clinical data. UNITY improves clinical specificity for cystic fibrosis carrier screening UNITY is the only prenatal screen that tests cell-free fetal DNA for cystic fibrosis, spinal muscular atrophy (SMA), sickle cell ...
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Cerapedics Announces FDA Approval of PMA Supplement Based on Two-Year Clinical Data
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that ...
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