Studies published this week have introduced a consensus-based definition of long COVID-19 in children and young persons, narrowing its prevalence estimates, which have been wildly divergent. Long COVID rates for adults are still unclear, but a recent meta-analysis estimated that between one third and two thirds of adult COVID-19 patients who had severe acute disease develop symptoms of long COVID. Read More
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic. Read More
These days it’s nearly impossible to turn around in the biopharma world without hearing about how some company is going to use machine learning to revolutionize drug development. “It really is a catchphrase,” acknowledged Jo Viney, whose latest startup, Seismic Therapeutic Inc. launched with a $101 million series A round to advance a platform incorporating machine learning capabilities to find new drugs for autoimmune diseases. Read More
Ventus Therapeutics Inc. closed a $140 million series C financing to continue scaling its platform to address previously undruggable targets. The company said it plans to advance programs targeting key modulators of the innate immune system and other therapies, including two targeting NLRP3 (NLR pyrin domain-containing 3) and one targeting cGAS, into the clinic. It plans to submit INDs for three programs in 2023. Read More
U.S. Health and Human Services Secretary Xavier Becerra is getting more pressure to take the unprecedented step of marching in on the patent rights protecting Astellas Pharma Inc.’s prostate cancer drug, Xtandi (enzalutamide), because of its U.S. price. Referencing the provision under the Bayh-Dole Act that allows federal agencies to march in on licensed patents stemming from federally funded research when the products are not available to the public on “reasonable terms,” a dozen Democratic congressional members wrote to Becerra Feb. 8 urging him to move forward on the Xtandi patents. Read More
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week. Read More
Lyme disease is the most common vector-borne disease in the U.S. and is also common in certain areas of Europe. Yet, despite this, there are no FDA-approved vaccines available to treat it, meaning those diagnosed must receive a dose of antibiotics. But antibiotics are problematic because of the risk of treatment-resistant strains emerging. That leaves a pressing need for a vaccine or other way to prevent infections from the tick-borne bacterium Borrelia burgdorferi. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AGTC, Alkermes, Astellas, Intrommune, Karyopharm, Ocuphire, Recce, Telix, Vasopharm.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Active, Adial, Appili, Aptevo, Argobio, Biomarin, Bridge, Cold Spring Harbor, Cyclica, Cytovation, Edigene, Eli Lilly, Foundation, Gain, Hummingbird, IGM, Immunome, Laboratorio Libra, Luye, Model Medicines, Moderna, Neukio, Oncode Institute, Oncodesign, Perturba, Purnovate, Saptalis, Sengine Precision Medicine, Siolta, Teva, Trestle, Zucara . Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Angelini, Destiny, Eyenovia, Nicox, Novo Nordisk. Read More
