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Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Servier is poised to go to market soon after the Phase III trial of its proposed drug for leukemia closed with positive results.
Octant announced an $80 million Series B financing round, a Deep Mutual Scanning (DMS) biopharma partnership with Bristol Myers Squibb and key appointments to its leadership.
Thirty-five members of the Bloomberg New Economy International Cancer Coalition issued a call for a permanent change to the way cancer is diagnosed and treated around the world.
Orasis Pharmaceuticals announced that its eye drop candidate CSF-1 met all primary and key secondary endpoints in Phase III clinical trials. CSF-1 is intended to treat presbyopia.
Clinical results announced this week could expand COVID-19 prevention options for the immunocompromised and vaccine ineligible, as well as those that have already contracted COVID.
Moderna is poised to seek the regulatory authorization of its COVID-19 vaccine in children between six months and 5 years.
COVID-19 continues to generate surprises, such as a possible link between dementia and severe COVID-19. Continue reading for that and more research stories.
The initial program will focus on one degrader combined with multiple proprietary E3 ligase platforms and use VantAI’s geometric deep learning platform.
British employees of pharma giant GlaxoSmithKline (GSK) have voted to strike against the company’s recent pay raise. The employees are backed by British labor union Unite.
Ampio shares continue to fall following the company’s announcement that the FDA rejected proposed changes to a Phase III study of its treatment for osteoarthritis of the knee and other joints.