Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired, part of a broader expansion in oncology.
The influential drug cost watchdog recommended a discount of between 37% and 54% to the $419,500 list price the companies charge for Abecma, a multiple myeloma cell therapy cleared by the FDA in March.
Some seven months after acquiring the rest of Akcea Therapeutics, Ionis is laying off most of the subsidiary's staff and turning to Sobi to sell its drugs.
According to Acadia, the FDA took issue with the main study used in its drug approval submission. That surprised the company, since regulators had never seemed concerned with the study's design.
Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect.
In a surprise announcement, the company said data used to tout the safety of the anemia pill roxadustat included "post hoc changes" that executives only became aware of during regulatory review.
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