Two reports, one from Democrats and one from Republicans, point fingers at the reasons prescription drug prices have risen so dramatically. Both came at a time when President Joe Biden wants to change the way drug prices are determined. Read More
Angion Biomedica Corp. CEO Jay Venkatesan said his firm is ransacking phase II data for “a clear and consistent trend” toward benefit with ANG-3777 before going to the next stage of development with the hepatocyte growth factor mimetic for patients undergoing cardiac surgery involving cardiopulmonary bypass who are at risk for developing acute kidney injury. A decision is due early next year. Read More
With 2021 coming to a close in just a few weeks, the U.S. FDA is racing to release the guidances it planned to get out the door this year. The regulator issued two draft guidances Dec. 7 detailing key clinical and production considerations to support applications for “N of 1,” or single-subject, clinical trials and drug development programs for severely debilitating or life-threatening diseases. Read More
COVID-19 kept its grip on the world in 2021 as one new variant after another created new waves of infection, forcing regulatory officials to face ongoing political and logistical pressures in dealing with drug and vaccine approvals, mergers and acquisitions, manufacturing issues and demands for pricing reforms. Read More
There was no slowing of biopharma innovation in 2021, even as industry directed significant resources to, while feeling the impact of, the ongoing COVID-19 pandemic. The year saw big wins for developers of DNA vaccines and biosimilars, while CAR T expanded its reach and a drug target once considered undruggable was finally conquered. And as 2021 gives way to 2022, other potentially game-changing technologies and therapeutics are waiting in the wings. Read More
Avistone Biotechnology Co. Ltd. raised more than $200 million to support its oncology drug development and the acquisition Pearl Biotechnology Co. Ltd. with the aim of creating a “fully-integrated” targeted oncology platform. Vivo Capital LLC led the financing, with participation from Bain Capital LP. and Primavera Capital Group. Read More
Canbridge Pharmaceuticals Inc. has raised HK$604 million ($77.4 million) with a listing on the Hong Kong stock exchange, selling about 56.3 million shares (1228.HK) at HK$12.18 per share. The shares fell to HK$8.90 at the close of trading Dec. 10. Almost half the funds will support advancement of Canbridge’s lead candidate, CAN-008, a glycosylated CD95-Fc fusion protein in phase II testing for glioblastoma, while another quarter will support other major pipeline programs. Read More
It was a busy year for biopharma deals, but as 2021 nears its end, activity is lagging 2020. BioWorld recorded 1,844 deals valued at $182 billion in 2021 vs. 2,067 deals valued at $198.2 billion for 2020. That puts 2021 behind last year on the volume of deals by more than 10% and on value by about 8%, but there are still three weeks to go. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Atai, Altasciences, Biotheranostics, Candel, Cara, CB, Eli Lilly, Enteris, Hologic, Incyte, Iteos, Novozymes, Regor, Relay, Springworks, SWK, Synergia, Syndax, Tryptage, Xortx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Aprea, Bayer, Brii, Cytodyn, Cytokinetics, Heron, Intercept, Nrx, Ocugen, Reata, Sesen, VBI. Read More
