Xpovio (selinexor), an oral selective inhibitor of nuclear transport from Karyopharm Therapeutics Inc., of Newton, Mass., received FDA approval today for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Xpovio will be available immediately in the U.S., the company said, and, due to COVID-19 restrictions, the launch will be a virtual one. Read More
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. Read More
LONDON – Epidarex Capital announced the closure of its £102.1 million (US$126.3 million) third fund, which will invest in very early stage biomedical and med-tech spin-outs from high-class but “under-ventured” universities in regions of the country where venture money is in short supply. Read More
A second attempt by Nabriva Therapeutics plc to win U.S. approval for the antibiotic Contepo (fosfomycin) has been undone by COVID-19. Manufacturing issues stymied the original NDA. This time, restrictions of FDA staff travel to Europe sunk the venture, leading to a new complete response letter (CRL) for the candidate as a potential treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Read More
In a BIO Digital session on “The Convergence of Health and Tech: Personalizing Medicine Beyond the Imaginable,” panelist Ray Deshaies, Amgen Inc.’s senior vice president of global research, said he was excited for the future of drug research, noting that there is an evolving trend away from the development of monospecific drugs designed to exert their effect on just one specific target. Read More
Zynerba Pharmaceuticals Inc. in late May popped the lid off top-line data from the open-label phase II study called Bright with ZYN-002 in children and adolescents with autism spectrum disorder, and the findings drew adjectives from Wall Street such as “provocative” and “encouraging.” Read More
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.” Read More
BEIJING – Suzhou, China-based Ascentage Pharma Group Inc. said on Monday that it is working with Astrazeneca plc’s hematology R&D unit, Acerta Pharma, to develop a combination therapy of its Bcl-2 inhibitor, APG-2575, with Acerta's BTK inhibitor, Calquence (acalabrutinib). The first patient has been dosed in the U.S. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Aridis, Aurinia, Evelo, FSD, Heat, Hookipa, Janssen, Merck, Myokardia, Onconova, Pfizer, Revolution, Springworks, Tarsius, Ziopharm. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Altimmune, Basilea, Bio-Thera, Deciphera, Merck, Nabriva, Regeneron, Resverlogix, Sanofi. Read More
