Gilead Sciences Inc. has acquired a 49.9% equity interest in privately held Pionyr Immunotherapeutics Inc., which could receive up to $1.15 billion in potential future milestone payments in the deal.
A new U.K. trial evaluating drugs for hospitalized patients in the early stages of COVID-19 has elected to test Evelo Biosciences Inc.'s anti-inflammatory monoclonal microbial, EDP-1815, after an earlier trial found it led to favorable anti-inflammatory activity in psoriasis patients.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
Arcus Biosciences Inc. “brings the milk without [Gilead Sciences Inc.] having to buy the whole cow” is the way one analyst characterized the pair’s 10-year cancer immunotherapy deal, which could be worth as much as $2 billion, and some may have detected downside for Arcus, as shares (NYSE:RCUS) closed May 27 at $27.05, down $6.49, or 19%. Foster City, Calif.-based Gilead is paying Arcus, of Hayward, Calif., $175 million up front, shelling out a $200 million equity investment, and pledging potentially $1.6 billion or more in the form of R&D support, opt-in cash and milestone payments.
Gilead Sciences Inc. and partner Galapagos NV touched off a round of Wall Street chin-scratching as they disclosed phase IIb/III data showing that JAK1 inhibitor filgotinib in ulcerative colitis (UC) at the 200-mg dose achieved all primary endpoints in the study called Selection.
According to an analysis conducted by BioWorld of the first quarter 2020 financial reports filed by the top 100 public biopharmaceutical companies ranked by market cap, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the period increased by 13% compared to the same period last year.
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
Having a COVID-19 therapy approved through an emergency use authorization (EUA) is not the same as having access to it, even if it’s free. Accounting for one-third of the nearly 4 million COVID-19 cases confirmed globally as of Monday and 28.5% of the 278,957 deaths, the U.S. is getting 40% of the 1.5 million vials of remdesivir Gilead Sciences Inc. is donating worldwide.
