PharmaMar/Jazz Pharmaceuticals get NDA priority for lung cancer drug

European Biotechnology | February 17, 2020

PharmaMar and Jazz Pharmaceuticals have received FDA Priority Review of a NDA for lurbinectedin in relapsed SCLC (Small Cell Lung Cancer). The PDUFA date was set for August 16, 2020 by the US Food and Drug Administration (FDA) for lurbinectedin as second-line treatment for patients with SCLC who relapsed following platium-based chemotherapy. The synthetic drug developed by PharmaMar SA (Madrid, Spain) and exclusively licenced by Jazz Pharmaceuticals plc (Dublin, Ireland) in December 2019 works by blocking RNA Polymerase II dependent oncogenic transcription programmes and modulating activity of tumour-associated macrophages.

Spotlight

The discovery that genes are made up of DNA and can be isolated, copied and manipulated has led to a new era of modern biotechnology. New Zealand has many applications for modern biotechnologies.

Spotlight

The discovery that genes are made up of DNA and can be isolated, copied and manipulated has led to a new era of modern biotechnology. New Zealand has many applications for modern biotechnologies.

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DIAGNOSTICS

MacroGenics Uses Genedata Profiler to Improve Immunotherapy Development

MacroGenics, Genedata | April 20, 2021

Genedata, the leading supplier of enterprise software solutions for biopharmaceutical R&D, revealed today a long-term collaboration agreement with MacroGenics, a biopharmaceutical firm and emerging pioneer in discovering and commercializing innovative immune-oncology therapeutics. The agreement provides MacroGenics access to Genedata Profiler® as well as consulting services to aid in the platform's accelerated adoption and integration into MacroGenics' R&D infrastructure. The use of Genedata Profiler improves MacroGenics' ability to generate new hypotheses from combined databases from both proprietary and public sources, assisting in the interpretation of biomarker data and the design of clinical trials. The Genedata Profiler software provides MacroGenics with a comprehensive solution that solves a variety of problems while also presenting new possibilities, such as: • Aggregation and curation of dispersed clinical and non-clinical research data, in a central repository, to create an institutional memory; • Self-service access to data and easy-to-use analytical tools empowers data scientists and clinicians to run complex analyses in a controlled and secure environment; • Cross-study and cross-technology data integration and analysis unlock actionable insights and facilitate informed decision-making; and • Automated workflows for data harmonization, integration, and analytics streamlines and standardizes analytical processes, while ensuring data reproducibility. MacroGenics profits from Genedata's technical domain experience in data analytics and interpretation, IT support, and scientific consulting in addition to software while retaining sole ownership of its proprietary data. The MacroGenics science team is collaborating closely with Genedata experts to unlock the potential of their data and advance their translational and clinical research programs. MacroGenics will be able to produce new scientific insights and hypotheses due to the streamlined, data-driven approach provided by Genedata Profiler. • Accelerate the discovery and development of predictive biomarkers indicative of therapy response to define the best subpopulation of patients to benefit from their immunotherapies, • Identify drugs’ specific indications to improve clinical trials inclusion criteria, • Determine the therapeutic mechanism of action (pharmacodynamics) to strengthen the rationale of the treatment regimen. Genedata Profiler, which is already in operation, has advanced MacroGenics' internal data organization and formatting. Data integration workflows and applied analytics conducted within the system have enhanced many existing translational/clinical trials and resulted in findings for presentations at international conferences (ASCO, ASH). MacroGenics will continue to work with Genedata to improve their analytical capability to help forward and reverse translational studies. About Genedata Genedata transforms data into intelligence with innovative software solutions and domain-specific consulting services that automate complex, large-scale experimental processes and enable organizations to maximize the ROI in their R&D, spanning early discovery to the clinic. Founded in 1997, Genedata is headquartered in Switzerland with additional offices in Germany, Japan, Singapore, the UK, and the US.

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MEDICAL

GT Biopharma Announces FDA Data - GTB-3550, for Treatment of High-risk Myelodysplastic Syndromes

GT Biopharma | December 23, 2020

GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology organization focused in on innovative treatments dependent on the Company's restrictive NK cell engager (TriKE™) innovation stage is satisfied to report the introduction of extra interval information results for the Company's lead therapeutic competitor, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS). Erica Warlick, M.D, Principal Investigator for the GTB-3550 clinical trial, introduced extra clinical data results with the treatment with HR-MDS persistent #7 of its TriKE™ GTB-3550 during the Q&A meeting following her introduction at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, "Our clinical data demonstrates that our proprietary TriKE™ (CD16/IL15/CD33), safely activated and harnessed the patient's native NK cell's cancer killing ability in a target-directed fashion without side effects. Which is not the case with highly expensive and intrusive supplemental NK cell therapies. We look forward to progressing to the next level."

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GenScript Receives FDA Emergency Use Authorization for cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript | November 10, 2020

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2. The conventional method for measuring neutralizing antibodies requires testing to be performed in a high safety-level facility (BSL3) staffed with specialized personnel. Typically, results from the live virus assay are available in several days and due to the unpredictable nature of the live virus and live cells reagents used, these tests are also difficult to standardize. Results from different facilities may vary, even if performed using the same protocol. In contrast, the cPass™ kit utilizes pure proteins that can be produced in a more reproducible way. The detection of the presence of neutralizing antibodies can also be performed in most standard research or clinical diagnostic laboratories with short turnaround time (~1hr), making it broadly available and much more consistent between different facilities. Furthermore, a comparison of the direct clinical performance between the conventional live virus and the cPass™ assay shows results from both tests are strongly correlated.

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