Humanetix and BioScience Managers partner to launch tech platform globally

Link to full article Humanetix is set for global expansion following a partnership with the international investment firm BioScience Managers (BSM). Humanetix’s main product ACE, is point-of-care documentation, decision-support and clinical workflow IT system that supports staff care delivery for residential aged care residents. The technology has been part of a 2-year trial conducted the […]

Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World’s First and Only Smart Knee Implant

Link to full article August 30, 2021— Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, and Canary Medical, a medical data company, today announced U.S. Food and Drug Administration (FDA) DeNovo classification grant and authorization to market the tibial extension for PersonaIQ®, the world’s first and only smart knee cleared […]

CalciMedica Reports Topline Data from the AuxoraTM CARDEA Phase 2 COVID-19 Pneumonia Clinical Trial

Link to full article Reduction in time to recovery through day 60 in patients with moderate and severe respiratory failure (primary endpoint analysis) Statistically significant reduction in time to recovery through day 60 in all patients who received study drug (a pre-specified supplementary analysis of the primary endpoint) Statistically significant 56% relative risk reduction in […]

CalciMedica Announces Publication of Preclinical Data in Journal of Immunology Further Validating Calcium Release-Activated Calcium (CRAC) Channels as Drug Targets for Diseases of the Airways

Link to full article Data provides further evidence of the broad potential for CRAC channel inhibitors to benefit patients across multiple disease areas involving the lungs LA JOLLA, Calif., September 9, 2021 – CalciMedica Inc. (“CalciMedica” or the “Company”), the CRAC channel company, today announced the publication of preclinical data validating calcium release-activated calcium (CRAC) channels, P2Y2 […]

Acrux receives FDA approval for its generic version of EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream

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 […]

Acrux receives approval from the FDA for its generic version of Jublia®

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 […]

Acrux confirms patent challenge for generic version of Aczone®

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%), […]

Acrux Announces Board Appointment

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 […]

CalciMedica 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 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, […]