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.

Worldwide, there’s a long line of long COVID studies

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 the disease. 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. People with long COVID were recognized and began to be studied in August 2020 and BioWorld is tracking 41 studies, some of which are well on the road to completion while others have yet to begin recruiting. There are three phase III studies planned and two phase II/III studies in progress.

Aiming for Seismic Impact, immunology-focused startup raises $101M series A 

Seismic Therapeutic Inc. launched today with a $101 million series A financing led by Lightspeed Venture Partners to advance a platform designed to use machine learning for drug discovery. But for the Watertown, Mass.-based company, machine learning is more than just an industry buzzword, said CEO Jo Viney, who explained how it would be integrated into a larger platform that includes protein engineering, structural biology and translational immunology, all with the aim of developing a pipeline of therapeutics targeting autoimmune disease.

Ventus brings in a $140M series C

Ventus Therapeutics Inc., of Waltham, Mass. and Montreal, closed a $140 million series C financing to continue scaling its platform to address previously undruggable targets. The company's lead program, VENT-01, is a small-molecule inhibitor of pro-inflammatory cytokines IL-1b and IL-18, key modulators in the innate immune system. The financing was co-led by Softbank Vision Fund 2 and RA Capital Management with participation from Qatar Investment Authority, Andreessen Horowitz, BVF Partners LP, Casdin Capital, Cormorant Asset Management, Fonds de solidarité FTQ, Alexandria Venture Investments, GV and founding investor Versant Ventures.

US lawmakers send Becerra marchin’ orders

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 certain patents to make the benefit of the invention “available to the public on reasonable terms,” a dozen Democratic congressional members wrote to Becerra yesterday urging him to move forward on the Xtandi patents. “It is our strongly held view that it is not reasonable to charge U.S. residents as much as five times the cost for a drug invented using American taxpayer dollars than the price offered to residents of other high-income countries,” the lawmakers said.

Biosimilars no priority in US FDA pandemic inspections

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. “The pandemic has impacted biosimilars and patient access disproportionately hard for almost two years,” Reed said, noting that as emerging variants continued to stall on-site inspections, the situation has become even more uncertain for biosimilars pending approval. Meanwhile, the FDA’s foreign inspections are still plagued by years-old challenges that must be addressed, the Government Accountability Office said in a report issued this week.

Undeterred by past traumas, Valneva and Pfizer press on with Lyme disease vaccine

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.

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