After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
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According to its SEC filing at the time, Boundless will use the IPO proceeds to fund the development of its extrachromosomal DNA (ecDNA) programs, being developed for cancer indications.
Citing a JAMA study that found Ozempic could be profitably produced at under $5 per month, Senator Bernie Sanders on Wednesday called on Novo Nordisk to lower prices for the diabetes treatment and the weight-loss drug Wegovy.
This transaction is the latest to highlight Big Pharma’s growing interest in developing novel targets for inflammation and immunology (I&I) treatments, as well as the potential for cutting-edge computational drug development.
Johnson & Johnson will get a new chance to contest the scientific evidence linking talc to ovarian cancer, a federal judge ruled on Wednesday, potentially disrupting more than 53,000 lawsuits the company is now facing over its talc products.
Moderna has entered into a development and commercialization funding agreement with asset management firm Blackstone Life Sciences to help advance its pipeline of flu vaccine candidates.
Bayer has really shaken up its C-suite, cutting its senior executive team by nearly half as part of a previously announced operating overhaul. In other news, the recently retired CEO of BioMarin joined the board of a bioinformatics AI firm, while a well-known former biopharma executive became a board member of a well-capitalized startup. Meanwhile, Dyne Therapeutics is losing its CEO to the investment world.
Avenzo Therapeutics on Tuesday said it will use the financing round to advance its next-generation oncology pipeline, including a potentially best-in-class CDK2 selective inhibitor.
While Pfizer has ended one of its two Phase III studies for inclacumab in sickle cell disease, the company is still eyeing an approval for the antibody in the inherited blood disorder by 2026.
Yesterday the FDA approved Merck’s treatment for adults with high blood pressure due to constriction of lung arteries, adding another potential blockbuster drug to the pharmaceutical giant’s portfolio.