Following two clinical trial disappointments, the newest being the phase III failure of ampreloxetine, Theravance Biopharma Inc. will restructure by laying off three-quarters of its staff and will stop developing all but two of its non-respiratory disease programs. The ampreloxetine study for treating symptomatic neurogenic orthostatic hypotension failed to meet its primary endpoint, the company announced Sept. 15. In late August, data from a phase IIb dose-finding study showed izencitinib, a gut-selective pan-JAK inhibitor for treating ulcerative colitis, failed to meet its primary endpoint. Read More
With the U.S. logging more than 4 million new COVID-19 cases in the past few weeks, federal purchasing of antibody cocktails from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. is continuing to grow. The government has placed orders for $2.94 billion worth of Regeneron's REGEN-COV (casirivimab and imdevimab) and about $330 million of Lilly's etesevimab to complement doses of bamlanivimab it previously purchased. Both antibody combinations, approved under FDA emergency use authorizations (EUAs), have been shown to reduce risk of hospitalization or death from COVID-19. Read More
The Biden administration’s haste to roll out an eight-month COVID-19 vaccine booster program next week is bumping up against the reality of the data and the regulatory process. Read More
The market’s appetite for immunology candidates in chronic disease – in particular an oral interleukin-17 (IL-17) therapy for psoriasis – was proved by the upsized IPO pulled off by Dice Therapeutics Inc., and Tyra Biosciences Inc. benefited from the ongoing appetite in precision oncology in another, bigger-than-expected debut. Preclinical-stage Pasithea Therapeutics Inc. went public as well, albeit less spectacularly. Read More
Chicago-based Vanqua Bio Inc. has raised $85 million in series B financing to accelerate development of its therapies tackling Parkinson’s and other neurodegenerative diseases. Founded in 2019, Vanqua’s technology is focused on developing small-molecule activators of glucocerebrosidase, an enzyme that regulates levels of lipids in cells. Read More
Continuing an upward trajectory, BioWorld’s Drug Developers Index (BDDI) has climbed more than 10% since the start of this year, following sharp drops at the end of March and May. Shares began to rebound in June and the index has shown a steady incline, similar with the Nasdaq Biotechnology Index, which is currently up 12%. Read More
The U.S. Federal Trade Commission (FTC) has taken a more assertive stance regarding enforcement of several considerations, most conspicuously about mergers and acquisitions. However, the agency’s push for less cumbersome processes has now been applied to a host of considerations pertinent to the life sciences, including bias found in artificial intelligence algorithms, abuse of drug patents, and repairs for medical equipment, a signal that more frequent and more rapid FTC enforcement is on the near horizon. Read More
Biopharmas raising money in public or private financings, including: Allarity, Allay, Alpine, Arbor, Atai, Avalo, Intelgenx and Lightstone Ventures. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Axsome, BMS, Harbour, Isa, Kalvista, Neurogene, Pharmamar, Telix. Read More
