PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.
Though founded in 2018, Inipharm Inc. has just closed on a $35 million series A financing designed to push its lead program through an IND filing and into the clinic to treat liver-related diseases.
As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.
Monday, Oct. 5, was probably the first day of 2020 that SARS-CoV-2 had serious competition for science media attention – by another virus. The Nobel Assembly awarded the 2020 Nobel Prize for Physiology or Medicine to Harvey Alter, Michael Houghton and Charles Rice “for the discovery of hepatitis C virus.”
Anti-infective drugs approved over the last two decades were able to get through the clinical development and FDA approval processes substantially faster than other drugs, according to a new report from the Tufts Center for the Study of Drug Development.
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct-acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
In a historic first, all prisoners and people covered through Medicaid in Louisiana got access last week to Asegua Therapeutics LLC's hepatitis C drug, even if they were in the early stages of the disease, thanks to a modified subscription program that's likely to serve as a model for other states in the U.S. looking for ways to pay for pricey cures and treatments emerging from the pipeline.
