Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.
BEIJING – Shanghai-based bispecifc antibody startup Epimab Biotherapeutics Inc. entered a research collaboration and license agreement with Brisbane, Australia-based QIMR Berghofer Medical Research Institute to look for novel bispecific target combinations, a move that could expand the startup’s pipeline.
CYBERSPACE – At a series of new drugs on the horizon sessions at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I, a variety of companies presented preclinical and clinical data for promising early stage oncology products.
Given all the public-private partnerships responding to the need for timely COVID-19 therapies, diagnostics and vaccines, the demands to forgo patents or exclusive licenses for coronavirus products and the clamor that industry shouldn’t “profit” from U.S. taxpayer-supported research are growing louder.
LONDON – The World Health Organization (WHO) launched a global collaboration to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics, with leaders of countries around the world appearing live to pledge their support.
Shares of Gilead Sciences Inc. were dented April 23 after reports surfaced that its antiviral drug, remdesivir, failed to improve the condition of patients with COVID-19.
With accelerated approval in hand for Trodelvy (sacituzumab govitecan-hziy) to treat metastatic triple-negative breast cancer (mTNBC), Immunomedics Inc. is looking ahead to data related to the next indication for the antibody-drug conjugate (ADC) – urothelial tumors – “in the near future,” Chairman Behzad Aghazadeh told investors during a conference call.
Recent seizures of fake medical products being marketed in the COVID-19 pandemic underscore the need to curb the growing international trade in counterfeit drugs that’s putting hundreds of thousands of lives at risk, the Organisation for Economic Cooperation and Development (OECD) warned this week.
LONDON – The search for modulators of the immune cascade that is the cause of the most severe respiratory symptoms of COVID-19 is intensifying, with Cyclacel Pharmaceuticals Inc. and Pharming Group NV adding their drugs to the list of repurposing projects.