The U.S. government bought 100 million doses of mRNA-1273 from Moderna Inc., of Cambridge, Mass., with a new award worth up to $1.525 billion, a deal that drops the implied cost per dose below that of several other companies receiving funding through the government program. Read More
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future. Read More
LONDON – Antifungal specialist F2G Ltd. has closed a $60.8 million round, providing the means to complete phase III development of the lead product olorofim, a treatment for life-threatening invasive infections, and to scale up in preparation for commercialization. Read More
A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday to $19.27, just shy of the offering price. "As a private company, we will have access to the resources and long-term commitment needed to better pursue new capital investment in existing assets and targeted acquisition opportunities as our sector continues to evolve, including further geographic and product diversification," CBMG CEO Tony Liu told employees. Read More
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.” Read More
The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter (CRL) highlighting safety concerns. Read More
Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively. Read More
PERTH, Australia – Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell (MSC) and secretome therapy, Progenza, to Japan’s Kyocera Corp. for osteoarthritis of the knee for the Japan market. Read More
HONG KONG – Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Azurrx, Blade, Boehringer, Botanix, Eloxx, Epirium, Nektar, Sapience, Vaccibody, VBL. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beroni, Beyondspring, Caribou, Cytovia, Fibrogenesis, Genecentric, Genscript, Helix, Hepion, Ikena, Itrom, Janssen, Mammoth, Monopar, Nicox, Novome, Proteonic, Therapeutics Solutions. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Arca, Ascendis, Eli Lilly, Epirium, Eyegate, Indian, Innovent, Kahr, Kineta, Pliant, Redhill, Regeneron, Seattle Genetics, Theranexus. Read More
