CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Ligand Pharmaceuticals | February 21, 2023
In a recent announcement by biopharmaceutical firm, Ligand Pharmaceuticals, the U.S. Food and Drug Administration (FDA) has given accelerated approval for FILSPARITM (sparsentan). This will be helpful in treating adults with primary IgAN condition who are at risk of rapid disease progression, typically defined as a urine protein-to-creatinine ratio (UPCR) of less than 1.5 g/g.
FILSPARI, a once-daily oral medicine, is the first and only non-immunosuppressive therapy authorized for the treatment of IgAN. Two critical pathways are selectively targeted of IgAN (endothelin-1 and angiotensin II) to check disease progression. Up to 150,000 Americans may have the rare kidney illness IgAN, which is the main cause of kidney failure brought on by glomerular disease. Among these patients, it is predicted that 30,000 to 50,000 can be treated using the indication that has received accelerated approval. Travere has stated that it anticipates FILSPARI to be available from February 27, 2023, and it will offer a thorough patient support program all the way through the patient's therapeutic journey.
Eric Dube, Ph.D., President and CEO of Travere Therapeutics, said, “The accelerated approval of FILSPARI is a significant milestone on our path to advancing a transformative treatment for the IgA nephropathy community.” He further added, “As a first-of-its-kind, non-immunosuppressive therapy, we believe FILSPARI has the potential to ultimately become the new standard of care for IgA nephropathy and offer hope to those living with this condition who until now have had few treatment options. We are grateful to the patients, caregivers, clinical trial investigators, healthcare providers, and advocates who have worked alongside us to develop this innovative first-in-class therapy.”
(Source – Business Wire)
About Ligand Pharmaceuticals
Ligand Pharmaceuticals creates or acquires technologies that aid in the discovery and development of drugs by pharmaceutical firms. The company’s business model generates value for stockholders by offering a diverse portfolio of biotech and pharmaceutical product income streams, that are underpinned by an effective and low corporate cost structure.
MEDTECH, INDUSTRIAL IMPACT
Bio-Techne | February 15, 2023
On February 14, 2023, Bio-Techne Corporation and Cell Signaling Technology (CST) announced that CST antibodies now have Simple Western™ validation. This will make it easier for researchers from numerous disciplines to study essential molecular signaling pathways on a reliable and validated platform.
Accurate data must be obtained quickly and efficiently in order to advance drug discovery and development. This continued collaboration will provide a broader menu of Simple Western validated antibodies for a variety of targets across several disciplines.
Simple Western systems from ProteinSimple, a brand of Bio-Techne, are the only completely automated western blotting solutions for protein identification and characterization, with results available in as little as 3 hours. Cell Signaling Technology (CST) is a leading developer of antibodies and other related reagents for elucidating cell signaling pathways that govern cellular behavior and have an impact on human health.
CST has finished assay validation and optimization for a variety of its antibodies on the Simple Western platform, making it easier than ever to develop new reliable and robust immunoassays for the quantification and detection of phospho and total proteins. When using CST primary antibodies with Simple Western validation, researchers can simply dilute the antibody to the appropriate dilution range found on the data sheet and product page. In addition, CST antibodies are Simple Western protocol compliant, which allows users to include these thoroughly validated antibodies into their existing workflows seamlessly.
Founded in 1981, Bio-Techne Corporation is a pioneer in the development and manufacturing of high-quality purified proteins and reagent solutions, particularly antibodies, cytokines and growth factors, immunoassays, tissue culture reagents, biologically active small molecule compounds, and cell and gene therapy workflow solutions, including T-Cell activation technologies. It also develops and produces diagnostic products for OEM and clinical clients, such as FDA-regulated calibrators, controls, blood gas and clinical chemistry controls, and other reagents. The company’s products are essential components of scientific investigation into molecular diagnostics and biological processes, which disclose the diagnosis, nature, genesis, and course of certain diseases.
Benchling | January 27, 2023
On January 27, 2023, Benchling, the R&D cloud that powers the biotechnology sector, announced that it has passed the System and Organization Controls (SOC) 2 certification. Schellman, an independent Certified Public Accounting (CPA) firm, conducted the Type 2 SOC 2 test according to the AICPA's SOC 2 standards.
Type 2 SOC 2 evaluates the design and operational performance of an organization's security processes and controls to meet its security goals and customer commitments during a predetermined evaluation period. Constant monitoring, evaluation, and modification of the requirements and security measures guarantee a secure environment for doing business.
The CISO at Benchling, Zach Powers, said, "Biotechs are managing an evolving landscape of security and compliance risks, and they require trusted software partners to help them meet these demands." He added, "At Benchling, we make the security, privacy, and compliance of our customers' sensitive data a company-wide, critical investment, not only through Type 2 SOC 2, but also through our best-in-class security team, our trust-but-verify processes, and our adherence to global compliance standards."
(Source – PR Newswire)
Benchling's R&D Cloud is the biotech R&D platform of choice, trusted by over 1,000 organizations worldwide in highly regulated areas such as biopharmaceuticals, agribusiness, industrials, and consumer packaged goods. Benchling is used by customers to securely store, standardize, and analyze crucial data related to the design and development of innovative biotech products. Benchling's objective is to protect client data; hence, the firm utilizes sophisticated data security and privacy protections and complies with tight regulatory regulations such as the NIST Cybersecurity Framework. The organization is also ISO 27001 certified.
The successful completion of Benchling's Type 2 SOC 2 inspection assures that its biotech clients can conduct crucial R&D work in the Benchling R&D Cloud while following the highest security requirements.
Benchling is a San Francisco-based firm that focuses on private and public life science cooperation by developing cloud-based software tools for digital DNA sequence editing, planning and performing experiments, evaluating data, and sharing research. More than 200,000 scientists from over 1,000 firms and 7,500 university and research institutions worldwide have used the Benchling R&D Cloud to create breakthrough discoveries and deliver the next generation of medicines, foods, and materials to market more quickly. In addition, the R&D cloud assists these companies in modernizing their scientific processes and accelerating their cooperation to transform the complexity of biology into world-changing outcomes.