Acrux’s sixth generic application accepted by FDA for review

Melbourne, Australia – 8 August 2022 Link here : Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce that the US Food and Drug Administration (FDA) has accepted for review Acrux’s application for a generic version (Abbreviated New Drug Application or ‘ANDA’) of cold sore treatment, Acyclovir Cream, 5%. Key Highlights Acrux has […]

Adherium submits FDA 510(k) application for next generation Hailie sensor for GSK pMDI inhalers

Melbourne, Australia – 2 August 2022 link here: Adherium Limited (“Adherium”; 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 its 510(k) clearance to market application, which connects GlaxoSmithKline® (GSK) Ventolin®, Advair®, and Flovent® pressurized metered-dose inhaler (pMDI) users […]

US FDA Clears IND for Cynata’s Phase 2 Clinical Trial of CYP-001 in GvHD

Link to full article Key Highlights: • US FDA has cleared Cynata’s IND application for a Phase 2 clinical trial of CYP-001 in patients with aGvHD – a major milestone and value catalyst for the Company • Phase 2 clinical study in aGvHD expected to commence subsequent to customary and satisfactory completion of negotiations with […]

Parkinson’s patients benefit from revolutionary watch on the NHS to manage care at home

Link to full article Patients with Parkinson’s disease are being given life-changing smart watches that allow doctors to remotely assess their condition in a pioneering project to revolutionise NHS care. The cutting-edge gadget containing sensors, known as a Parkinson’s Kinetigraph (PKG), is worn around the clock for six days to monitor patients’ movements at home. […]

Cynata Advances Clinical Trial in Diabetic Foot Ulcers

Link to full article Melbourne, Australia; 21 April 2022: Cynata Therapeutics Limited (ASX: “CYP” or “Cynata”), a clinicalstage biotechnology company specialising in cell therapeutics, is pleased to announce enrolment of initial patients in a clinical trial of CYP-006TK as a potential treatment for diabetic foot ulcers (DFU). Subjects are now being followed as planned for […]

CalciMedica Announces Publication of Results from CARDEA COVID-19 Study in Critical Care

Link to full article April 14, 2022 – Results further support therapeutic potential of Auxora in respiratory diseases and other inflammatory diseases – LA JOLLA, Calif., April 14, 2022 – CalciMedica Inc. (CalciMedica or the Company), the CRAC (calcium release-activated calcium) channel company, today announced the publication of results from the Company’s CARDEA clinical trial, a Phase […]

Armata Pharmaceuticals Announces First Patient Dosed in Phase 1b/2a ‘diSArm’ Study of AP-SA02 in Adults with Bacteremia due to Staphylococcus aureus

Link to full article MARINA DEL REY, Calif., May 23, 2022 /PRNewswire/ — Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata” or the “Company”), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the first patient has been dosed in the company’s Phase 1b/2a clinical trial (‘diSArm’) of AP-SA02, which is […]

Adherium Releases Next Generation Respiratory Platform Integration Services

Link to full article Melbourne, Australia – 28 April 2022: Adherium (ASX: ADR), a leader in respiratory eHealth, remote monitoring, and data management solutions, announces the release of the latest Hailie® platform integration tools comprised of an advanced Rest application programming interface (API) and a new, updated software development kit (SDK) to improve connection with […]

Adherium appoints Vice President of Global Business Development to drive commercial growth

Link to full article Melbourne, Australia – 22 April 2022: Adherium Limited (ASX: ADR), a leader in respiratory eHealth, remote monitoring and data management solutions is pleased to announce it has significantly strengthened its international commercial leadership team with the appointment of Mr Francis White as Vice President of Global Business Development based in the […]