Citing the limited supplies and the pricing of the COVID-19 therapy, nearly three dozen U.S. states and territories are clamoring for the federal government to march in on Gilead Sciences Inc.’s patents for remdesivir. And if the feds won’t, then states should be given that authority, according to a letter sent Tuesday to the Department of Health and Human Services, the NIH and the FDA.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axsome, Diurnal, Pharmacyte, Revive.
The latest global regulatory news, changes and updates affecting biopharma, including: Medicines and Healthcare Products Agency, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
NEW DELHI – If India’s government has its way, the country could launch a vaccine for COVID-19 in mid-August, an extremely short deadline that has caused controversy and pushed companies to speed up their development and the trials of prospective vaccines.
Chinese biosimilar maker Shanghai Henlius Biotech Inc. won EMA approval for its Zercepac, a biosimilar to Roche Holding AG’s Herceptin (trastuzumab) on July 28. Henlius CEO Scott Liu told BioWorld that Zercepac will be the first Chinese monoclonal antibody biosimilar to enter the EU market, setting a precedent for Chinese drugmakers seeking to join the global race in biosimilars.
The U.S. FDA gave an emergency use authorization (EUA) to the first semi-quantitative antibody test from Siemens Healthineers AG for the SARS-CoV-2 virus. This test, known as the SARS-CoV-2 IgG (COV2G) antibody test, could potentially be used repeatedly over time to assess relative levels to gauge potential immunity.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Biotricity, Siemens Healthineers.
RSS
