Melbourne, Australia; 28 July 2021: Acrux Limited (ASX:ACR) (‘Acrux’ or the ‘Company’) is pleased to announce that the US Food and Drug Administration (‘FDA’) has approved its generic version of EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream. In June 2019, Acrux submitted an ANDA to seek approval from the FDA to market its generic version […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-07-28 05:22:482021-07-30 05:25:05Acrux receives FDA approval for its generic version of EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream
Link to Full Article GENinCode Plc are pleased to announce the publication of its Thrombo inCode® prospective case-control study performed at the Karolinska Institute, Sweden. The positive clinical results strengthen Thrombo inCode® as a leading diagnostic for the diagnosis of inherited thrombophilia and venous thromboembolism (“VTE”). The study returned positive clinical results which strengthen Thrombo […]
Link to Full Article GENinCode the predictive genetics and cardiovascular disease company focused on the prevention of cardiovascular disease is thrilled to announce the completion of its IPO and subsequent listing on the London Stock Exchange. NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, THE REPUBLIC OF IRELAND OR […]
Link to Full Article Cambridge, United Kingdom – Congenica, the digital health company enabling rapid and accurate analysis of complex genomic data to transform people’s lives, today announces that its genomic interpretation software is now CE marked under the In Vitro Diagnostics Directive (98/79/EC). With the In Vitro Diagnostic (IVD) designation, Congenica’s clinical decision support platform […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-07-21 02:15:242021-08-02 02:22:59Congenica Receives CE Mark for Genomic Analysis Software
Link to Full Article Soterius, an Australian medical device startup in the field of respiratory infection has selected MIP Diagnostics, a UK specialist in molecularly imprinted polymers for the affinity reagent in their novel COVID-19 biosensor. The Soterius biosensor utilizes MIP Diagnostics’ COVID-19 nanoMIP, which acts as a synthetic antibody to the SARS-CoV-2 spike protein. […]
Melbourne, Australia; 22 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce that the US Food and Drug Administration (FDA) has granted approval of the Company’s generic version of Jublia® (efinaconazole) topical solution, 10%. Key Points FDA’s approval of the application represents an important milestone for Acrux, being its second approval […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-06-22 05:09:192021-07-01 05:11:19Acrux receives approval from the FDA for its generic version of Jublia®
Link to Full Article GENinCode UK Limited, the cardiovascular disease company focused on predictive genetics for the prevention of cardiovascular disease, announces its partnership with EVERSANA Life Sciences LLC (“EVERSANA”) as its launch and commercialisation partner to access the United States market for the GENinCode portfolio of polygenic cardiovascular disease (“CVD”) products focused on genetic risk. EVERSANA is a […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-06-14 05:11:282021-06-17 05:13:08GENINCODE ANNOUNCES MAJOR US COMMERCIALISATION PARTNERSHIP WITH EVERSANA
Link to Full Article Cambridge, UK, 10 June 2021: Arecor Therapeutics plc (AIM: AREC), a globally focused biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces the appointment of Dr. Lindsey Foulkes as the Company’s Chief Operating Officer. Lindsey brings a wealth of deep expertise and experience from the life science industry, with […]
Melbourne, Australia; 8 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) today announced that Almirall LLC has initiated patent litigation against Acrux in the U.S. District Court for the District of New Jersey, regarding the Company’s Paragraph IV Abbreviated New Drug Application (ANDA) for Dapsone Gel 7.5% (a generic version of Aczone® Gel, 7.5%), […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-06-08 04:41:492021-06-17 04:44:03Acrux confirms patent challenge for generic version of Aczone®
Destiny Pharma
/in Destiny PharmaAcrux receives FDA approval for its generic version of EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream
/in AcruxMelbourne, Australia; 28 July 2021: Acrux Limited (ASX:ACR) (‘Acrux’ or the ‘Company’) is pleased to announce that the US Food and Drug Administration (‘FDA’) has approved its generic version of EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream. In June 2019, Acrux submitted an ANDA to seek approval from the FDA to market its generic version […]
GenInCode POSITIVE THROMBO INCODE CLINICAL RESULTS
/in GenInCodeLink to Full Article GENinCode Plc are pleased to announce the publication of its Thrombo inCode® prospective case-control study performed at the Karolinska Institute, Sweden. The positive clinical results strengthen Thrombo inCode® as a leading diagnostic for the diagnosis of inherited thrombophilia and venous thromboembolism (“VTE”). The study returned positive clinical results which strengthen Thrombo […]
GenInCode ADMISSION TO TRADING RNS
/in GenInCodeLink to Full Article GENinCode the predictive genetics and cardiovascular disease company focused on the prevention of cardiovascular disease is thrilled to announce the completion of its IPO and subsequent listing on the London Stock Exchange. NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, THE REPUBLIC OF IRELAND OR […]
Congenica Receives CE Mark for Genomic Analysis Software
/in CongenicaLink to Full Article Cambridge, United Kingdom – Congenica, the digital health company enabling rapid and accurate analysis of complex genomic data to transform people’s lives, today announces that its genomic interpretation software is now CE marked under the In Vitro Diagnostics Directive (98/79/EC). With the In Vitro Diagnostic (IVD) designation, Congenica’s clinical decision support platform […]
Soterius selects MIP Diagnostics’ synthetic antibodies for rapid COVID-19 biosensor
/in MIP DiagnosticsLink to Full Article Soterius, an Australian medical device startup in the field of respiratory infection has selected MIP Diagnostics, a UK specialist in molecularly imprinted polymers for the affinity reagent in their novel COVID-19 biosensor. The Soterius biosensor utilizes MIP Diagnostics’ COVID-19 nanoMIP, which acts as a synthetic antibody to the SARS-CoV-2 spike protein. […]
Acrux receives approval from the FDA for its generic version of Jublia®
/in AcruxMelbourne, Australia; 22 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce that the US Food and Drug Administration (FDA) has granted approval of the Company’s generic version of Jublia® (efinaconazole) topical solution, 10%. Key Points FDA’s approval of the application represents an important milestone for Acrux, being its second approval […]
GENINCODE ANNOUNCES MAJOR US COMMERCIALISATION PARTNERSHIP WITH EVERSANA
/in GenInCodeLink to Full Article GENinCode UK Limited, the cardiovascular disease company focused on predictive genetics for the prevention of cardiovascular disease, announces its partnership with EVERSANA Life Sciences LLC (“EVERSANA”) as its launch and commercialisation partner to access the United States market for the GENinCode portfolio of polygenic cardiovascular disease (“CVD”) products focused on genetic risk. EVERSANA is a […]
ARECOR APPOINTS DR. LINDSEY FOULKES AS CHIEF OPERATING OFFICER
/in ArecorLink to Full Article Cambridge, UK, 10 June 2021: Arecor Therapeutics plc (AIM: AREC), a globally focused biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces the appointment of Dr. Lindsey Foulkes as the Company’s Chief Operating Officer. Lindsey brings a wealth of deep expertise and experience from the life science industry, with […]
Acrux confirms patent challenge for generic version of Aczone®
/in AcruxMelbourne, Australia; 8 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) today announced that Almirall LLC has initiated patent litigation against Acrux in the U.S. District Court for the District of New Jersey, regarding the Company’s Paragraph IV Abbreviated New Drug Application (ANDA) for Dapsone Gel 7.5% (a generic version of Aczone® Gel, 7.5%), […]