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®
Link to Full Article Cambridge, UK, 7th June 2021: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that it has signed a formulation study agreement with Par Sterile Products, LLC, an Endo International plc company (“Par”). Under this agreement, Arecor will use its proprietary formulation technology […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-06-07 04:49:032021-06-17 04:56:40ARECOR EXCLUSIVE FORMULATION STUDY COLLABORATION WITH PAR STERILE PRODUCTS TO DEVELOP A STABLE READY TO USE PRODUCT
Melbourne, Australia; 4 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce Mr Don Brumley has joined the Board as a Non-executive Director. Mr Brumley has 30 years’ experience as a senior partner of Ernst & Young, Oceania. He has extensive experience in IPOs, transactions and audit. Mr Brumley has advised […]
Link to Full Article Brighton, United Kingdom – 3rd June 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, announces that all resolutions proposed to shareholders at the Annual General Meeting held earlier today were duly passed. The full text of each resolution was included […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-06-03 05:06:222021-06-17 05:07:40Destiny Pharma Result of Annual General Meeting
Link to Full Article Data from Phase 2a Study Demonstrated Patients Treated with Auxora Experienced Reduced Severity of Acute Pancreatitis, Less Persistent Systemic Inflammatory Response Syndrome (SIRS) and More Rapid Restoration of Gut Function with Favorable Safety Profile Patient dosing has begun in Phase 2b study in acute pancreatitis; data expected H2 2022 LA JOLLA, […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-06-02 05:02:272021-06-17 05:03:37CalciMedica Publishes Positive Data from Phase 2a Study of Auxora in Patients with Acute Pancreatitis and Announces First Patients Dosed in Phase 2b Study
Link to Full Article MIP Diagnostics Ltd. has today shared the news that its COVID-19 nanoMIP outperforms commercial antibodies in a sensor platform, which could enable improved detection of lower viral loads during a wider infection period. Following the launch of its COVID-19 nanoMIP in April 2021, the business has worked with external collaborators to […]
Link to Full Article Melbourne, Australia – 1 June 2021: Adherium Limited (ASX: ADR), a leader in respiratory eHealth, remote monitoring and data management solutions, today announced submission to the US Food and Drug Administration (FDA) of a 510(k) clearance to market application for its first next generation Hailie® sensor with physiological measures for monitoring Asthma […]
/wp-content/uploads/2018/01/BSM_logo.png00victoria/wp-content/uploads/2018/01/BSM_logo.pngvictoria2021-06-01 04:46:472021-06-17 04:48:08Adherium submits US FDA 510(k) application for next generation Hailie® sensor with physiological measures
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%), […]
ARECOR EXCLUSIVE FORMULATION STUDY COLLABORATION WITH PAR STERILE PRODUCTS TO DEVELOP A STABLE READY TO USE PRODUCT
/in ArecorLink to Full Article Cambridge, UK, 7th June 2021: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that it has signed a formulation study agreement with Par Sterile Products, LLC, an Endo International plc company (“Par”). Under this agreement, Arecor will use its proprietary formulation technology […]
Acrux Announces Board Appointment
/in AcruxMelbourne, Australia; 4 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce Mr Don Brumley has joined the Board as a Non-executive Director. Mr Brumley has 30 years’ experience as a senior partner of Ernst & Young, Oceania. He has extensive experience in IPOs, transactions and audit. Mr Brumley has advised […]
Destiny Pharma Result of Annual General Meeting
/in Destiny PharmaLink to Full Article Brighton, United Kingdom – 3rd June 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, announces that all resolutions proposed to shareholders at the Annual General Meeting held earlier today were duly passed. The full text of each resolution was included […]
CalciMedica Publishes Positive Data from Phase 2a Study of Auxora in Patients with Acute Pancreatitis and Announces First Patients Dosed in Phase 2b Study
/in CalcimedicaLink to Full Article Data from Phase 2a Study Demonstrated Patients Treated with Auxora Experienced Reduced Severity of Acute Pancreatitis, Less Persistent Systemic Inflammatory Response Syndrome (SIRS) and More Rapid Restoration of Gut Function with Favorable Safety Profile Patient dosing has begun in Phase 2b study in acute pancreatitis; data expected H2 2022 LA JOLLA, […]
MIP Diagnostics’ COVID-19 nanoMIP offers significantly improved sensitivity to antibodies in a diagnostic sensor
/in MIP DiagnosticsLink to Full Article MIP Diagnostics Ltd. has today shared the news that its COVID-19 nanoMIP outperforms commercial antibodies in a sensor platform, which could enable improved detection of lower viral loads during a wider infection period. Following the launch of its COVID-19 nanoMIP in April 2021, the business has worked with external collaborators to […]
Adherium submits US FDA 510(k) application for next generation Hailie® sensor with physiological measures
/in AdheriumLink to Full Article Melbourne, Australia – 1 June 2021: Adherium Limited (ASX: ADR), a leader in respiratory eHealth, remote monitoring and data management solutions, today announced submission to the US Food and Drug Administration (FDA) of a 510(k) clearance to market application for its first next generation Hailie® sensor with physiological measures for monitoring Asthma […]