Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.
The FDA approved GSK drug Jesduvroq for treating anemia in patients with chronic kidney disease. The once-daily pill is the first oral medicine to pass FDA muster in this indication, giving patients a more convenient alternative to injectable anemia therapies.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, vadadustat, and asked for another clinical trial. Otsuka alleges unspecified breaches of the agreement by Akebia, and ending the alliance early could spare it from spending hundreds of millions of dollars more on the drug.
The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety concerns and asked for another clinical trial to show that the pill’s benefits outweigh its risks.
Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment for pyruvate kinase deficiency, a rare disease that leads to chronic anemia.
A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicine. CEO John Quisel said Roche's clinical data showed the small molecule's promise addressing a rare blood disorder and now the biotech startup has $90 million to advance that drug and another one into Phase 2 testing.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The next phase for Fe3 is clinical trials in order to obtain CE Mark and FDA approval.
Since 2014, True North Therapeutics has raised $97 million for its unique approach to autoimmune disease. Its initial clinical work treats a rare anemia.
New York biotech Abeona Therapeutics is taking a CRISPR/Cas9 approach to treating a rare anemia - and just raised $8.5 million in equity to bring it a little closer to clinic.
(Reuters) Express Scripts Holding Co, the largest U.S. pharmacy benefit manager, on Friday said it will remove 25 products from its 2015 list of preferred drugs, including anemia treatments Epogen and Aranesp, both sold by Amgen Inc. The company will continue to include Procrit, a similar anemia drug sold by Johnson & Johnson, on its […]
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