Regulatory
Companies and patients alike are questioning the Federal Trade Commission’s challenges to various biopharma agreements.
Shares of several biopharma companies in the CAR-T space dropped after the FDA’s announcement, but analysts remain optimistic about the sector’s future.
Carl Icahn is seeking to get rid of “legacy conflicted directors” on Illumina’s board following the announcement that GRAIL will be divested after a drawn out antitrust battle with regulators.
There is no evidence that the lapses have harmed patients who received Spikevax or clinical trial participants who received investigational shots.
Following a U.S. appeals court decision, the company said it is preparing to divest GRAIL through a third-party sale or capital markets transaction.
A European Medicine Agency panel on Friday reaffirmed its decision not to renew the conditional marketing authorization for GSK’s multiple myeloma drug Blenrep.
President Joe Biden has long promised to stand up to Big Pharma, lower prescription drug prices and limit the power of drugmakers—a pledge he seems intent on keeping.
A week after securing FDA approval, a European Medicines Agency committee has endorsed Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease and transfusion‑dependent beta thalassemia.
The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.
The Biden administration on Thursday said 48 drugs covered under Medicare’s Part B may be subject to inflation rebates in the first quarter of 2024 under the Inflation Reduction Act.
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