Generate Biomedicines Inc., a company building a machine learning platform to discover new protein therapies, raised $370 million in series B financing supported by its founder, Flagship Pioneering, and institutional co-investors. Its team plans to have multiple preclinical programs by year-end with several moving to the clinic in 2023.
A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said. Company shares (TSX:APLI) plummeted Nov. 11, falling 53.6% to CA26 cents (US21 cents). Originally approved for the treatment of pandemic flu, favipiravir has since gained marketing authorizations for the treatment of COVID-19 in several markets.
Ankyra Therapeutics Inc., a company developing new cytokine immunotherapies to boost localized antitumor immune responses, closed a $45 million series B financing. Proceeds from the round will be used to advance the Boston-based company's lead molecule, ANK-101, through IND-enabling studies and into phase I trials starting at the beginning of 2023, as well as to advance additional cytokine programs, it said.
U.S. President Joe Biden on Nov. 12 announced his intent to nominate former FDA Commissioner Robert Califf to return to the regulator’s top job. He would take the place of Janet Woodcock, acting commissioner of the agency since Jan. 20.
A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said.
Just months after completion of its spinout from Merck & Co. Inc., Organon & Co. has revealed plans to fold in a second acquisition: the Finnish firm Forendo Pharma Ltd., which is advancing an early stage candidate for endometriosis. The deal includes $75 million up front and as much as $870 million in potential milestone payments for Forendo owner Karolinska Development AB, which said the buyout is one of the largest biotech transactions in the Nordic region. Earlier deals rounding out the company's recent story include a Merck-facilitated acquisition of Alydia Health Inc. and a July deal with Obseva SA.
Zai Lab Ltd. and Blueprint Medicines Corp. have inked an exclusive collaboration and license agreement for the development and commercialization of two candidates for the potential treatment of patients with EGFR-driven non-small-cell lung cancer (NSCLC) in greater China, where Clarivate forecasts total NSCLC market sales are poised to grow from $3.2 billion in 2020 to $9.5 billion in 2030.
Results from two pivotal phase III trials testing Glaxosmithkline plc's daprodustat against anemia due to chronic kidney disease (CKD) found the oral hypoxia-inducible factor prolyl hydroxylase inhibitor helped both non-dialysis and dialysis patients improve or maintain hemoglobin levels without increased cardiovascular risk vs. standard-of-care erythropoietin stimulating agents. Though already approved in Japan as Duvroq, what future the drug might face in the U.S., where the same-class drug roxadustat garnered an FDA complete response letter, remained an open question.
Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
