LONDON – CEOs of five leading biopharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere. The most important thing is to reinforce to the public the commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc. Read More
While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA. Read More
Akebia Therapeutics Inc. CEO John Butler said “a clear path forward” exists for vadadustat in chronic kidney disease (CKD) despite negative phase III safety findings, and the company plans to file for approval as early as next year in the U.S. and Europe. Read More
Rain Therapeutics Inc., a California company developing targeted cancer therapies with a biomarker-based strategy, has raised a $63 million series B round led by Boxer Capital to support its development of the small-molecule MDM2 inhibitor RAIN-32 (milademetan) for the potential treatment for liposarcoma and other cancers. Read More
In its second acquisition of the past four weeks, Lodo Therapeutics Corp., acquired Hibiskus Biopharma Inc. plus exclusive worldwide rights from the University of California Riverside and Michigan State University to preclinical proteasome and immunoproteasome inhibitors developed by Hibiskus’ two co-founders. Read More
Researchers at City of Hope have used a combination of oncolytic virus and CD19-targeting CAR T cells to first force expression of CD19 on tumor cells and then hunt down those cells, eradicating tumors in immunocompetent mouse models and endowing them with immunity to later re-administration of tumor cells. Read More
Biofourmis Inc. scooped up $100 million in a series C round that was led by Softbank Vision Fund 2. The funds are earmarked to accelerate U.S. and global expansion of Biofourmis’ artificial intelligence (AI)-powered health analytics platform and to advance its pipeline of digital therapeutics. The company focuses software-based therapeutics and AI tools for personal predictive care and has U.S. FDA-cleared products that aim to boost clinicians’ ability to remotely monitor and treat patients. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Akebia, Auris, Bio-Thera, Celecor, Exact, GSK, Hutchison China Meditech, Incyte, Lattice, Madrigal, Novan, Novavax, Octapharma, Sanofi, Sutro, Tonix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allergy, AMRI, Astrazeneca, Biocryst, CNS, Deepvax, Diurnal, Enesi, Gilead, Geovax, Ionis, Pharnext, Redhill, Saliba, Vistagen, Xencor. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeon, Cytodyn, Innovent, Nippon Shinyaku. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Alkermes, Amarin, Gilead, McKesson, Novartis, Oncolix. Read More
