While there is tremendous enthusiasm for GLP-1 drugs for use in obesity, and 80% of the U.S. population is eligible to use the therapies, tremendous obstacles continue to block their access. The blockages include high prices that consumers currently cannot afford coupled with employer health plans that don’t offer the new treatments.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc.
While there is tremendous enthusiasm for GLP-1 drugs for use in obesity, and 80% of the U.S. population is eligible to use the therapies, tremendous obstacles continue to block their access. The blockages include high prices that consumers currently cannot afford coupled with employer health plans that don’t offer the new treatments. A panel discussing the future of GLP-1s at the BioFuture 2024 conference in New York said the next five years will see enormous changes in the way these drugs are prescribed by physicians and used by patients.
Artificial intelligence (AI) is enabling a foundational understanding of drug discovery that is changing the typical pathway used in modern development. The powerful new computer technology will lead developers from conducting hypothesis-driven research to more and deeper data-driven research, Manolis Kellis, professor at the Computer Science and Artificial Intelligence Laboratory at the Massachusetts Institute of Technology (MIT) and an associate member at the Broad Institute of MIT and Harvard University, told those attending the BioFuture 2024 conference in New York on Oct. 28.
With the U.S. FDA’s approval of Orlynvah (sulopenem etzadroxil and probenecid) for uncomplicated urinary tract infections, Iterum Therapeutics plc can move on from regulatory delays and prepare to launch only the second FDA-approved treatment for the indication in the past 20 years.
Privately held Dyno Therapeutics Inc. has added another notch to its adeno-associated virus (AAV) vectors development portfolio in a deal with the Roche Group that includes $50 million up front and ultimately could top $1 billion. Dyno will help in developing next-generation AAV vectors, optimized by artificial intelligence, to target neurological diseases.
Privately held Dyno Therapeutics Inc. has added another notch to its adeno-associated virus (AAV) vectors development portfolio in a deal with the Roche Group that includes $50 million up front and ultimately could top $1 billion. Dyno will help in developing next-generation AAV vectors, optimized by artificial intelligence, to target neurological diseases.
Modifi Biosciences Inc. has come a long way very quickly. Spun out of Yale University in 2021, it published data on DNA in Science in July 2022, and now it’s being acquired by Merck & Co. Inc. for $30 million up front. Ultimately, Modifi shareholders could receive milestones of up to $1.3 billion.
Modifi Biosciences Inc. has come a long way very quickly. Spun out of Yale University in 2021, it published data on DNA in Science in July 2022, and now it’s being acquired by Merck & Co. Inc. for $30 million up front. Ultimately, Modifi shareholders could receive milestones of up to $1.3 billion.
It’s a go for the two phase III Ensure studies of Immunic Inc.’s lead asset in treating relapsing multiple sclerosis. An unblinded data monitoring committee’s interim futility analysis concluded that the placebo-controlled, pivotal studies using vidofludimus calcium may continue as planned, with the program expected by the company to be completed in 2026.
