my.bionity.com
With an accout for my.bionity.com you can always see everything at a glance – and you can configure your own website and individual newsletter.
SR Pharma plc announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application (IND) for a second siRNA therapeutic which is based on the company 's unique proprietary chemistry. The product is AKIi-5, which is being developed by Quark Biotech Inc for the treatment of Acute Kidney Injury (AKI). This product was licensed to Quark Biotech Inc. by SR Pharma's subsidiary Atugen and its structure and composition of matter is protected by Atugen's patent portfolio.
AKIi-5 is Quark's lead product candidate for the prevention of Acute Kidney Injury in high-risk patients undergoing major cardiovascular surgery. The product is expected to reduce the frequency of post-surgery AKI requiring dialysis as well as AKI associated mortality. AKI is a very serious disease with a 50-70% mortality rate in patients developing it in the intensive care unit and up to 88% in patients developing the disease following major cardiovascular surgery. Over the past 40 years, the survival rate for AKI has not improved. In patients at the highest risk-level, AKI incidence is 22%.
Iain Ross, Executive Chairman of SR Pharma stated, "We are very excited by this achievement, as this is the second product based upon our proprietary AtuRNAi chemistry which has been approved for use in humans. Only last month we announced that the AtuRNAi compound RTP-801i, which we sub-licensed to Pfizer through our partner Quark Biotech Inc. for the treatment of Age-related Macular Degeneration, was moving into the clinic."
SR Pharma plc announced that Quark Biotech Inc. has started a Phase I clinical trial with RTP-801i, a small interfering RNA (siRNA) therapeutic product licensed from Atugen AG, a subsidiary of SR Pharma plc. RTP-801i is based on Atugen's proprietary siRNA (AtuRNAi) technology and modifies t ... more
SR Pharma Granted Core RNAi Patent by the European Patent Office
SR Pharma plc announced that the European Patent Office has granted the Company its core RNAi patent EP 03784183.0. This patent covers its novel, stabilised, small interfering RNA (siRNA) molecules with blunt ends and positional modifications. These proprietary siRNA molecules are referred ... more
SR Pharma plc and its operating subsidiary Atugen AG announce that studies at the Charité Hospital, Berlin have demonstrated the therapeutic efficacy of Atu027 RNAi in animal models of pancreatic cancer. The data showed both inhibition of cancer growth and prevention of metastatic spread, d ... more
FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing
PerkinElmer, Inc. announced that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this ... more
Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization
Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab sampl ... more
Merck and Pfizer receive FDA approval for kidney cancer therapy
Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part o ... more
SR Pharma plc announced that Quark Biotech Inc. has started a Phase I clinical trial with RTP-801i, a small interfering RNA (siRNA) therapeutic product licensed from Atugen AG, a subsidiary of SR Pharma plc. RTP-801i is based on Atugen's proprietary siRNA (AtuRNAi) technology and modifies t ... more
SR Pharma Granted Core RNAi Patent by the European Patent Office
SR Pharma plc announced that the European Patent Office has granted the Company its core RNAi patent EP 03784183.0. This patent covers its novel, stabilised, small interfering RNA (siRNA) molecules with blunt ends and positional modifications. These proprietary siRNA molecules are referred ... more
SR Pharma plc announced that studies at the Charité Hospital have demonstrated the superior therapeutic efficacy of Atu027 RNAi in pre-clinical models of pancreatic cancer when compared to the standard care treatment. The data showed both inhibition of cancer growth and prevention of metast ... more
SR Pharma plc announced that Quark Biotech Inc. has started a Phase I clinical trial with RTP-801i, a small interfering RNA (siRNA) therapeutic product licensed from Atugen AG, a subsidiary of SR Pharma plc. RTP-801i is based on Atugen's proprietary siRNA (AtuRNAi) technology and modifies t ... more
