Rare diseases currently afflict 300 million people worldwide and 30 million people in the U.S. alone. However, 95% of these diseases lacked an FDA-approved treatment as of January 2023. One reason, industry leaders say, is cost.
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AbbVie on Wednesday entered into a strategic partnership with OSE Immunotherapeutics to advance the French biotech’s early-stage monoclonal antibody OSE-230 as a treatment for chronic and severe inflammation.
The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.
AstraZeneca on Monday shut down the bulk of its roxadustat partnership with FibroGen, returning the rights to develop and commercialize the investigational HIF-PH inhibitor in the U.S. and other AstraZeneca territories to the biotech.
Viking Therapeutics announced Tuesday that its GLP-1/GIP receptor dual agonist helped patients lose up to nearly 15% of their weight over about three months in a Phase II study.
The $100-million facility is expected to employ over 1,500 employees and will be used to enhance its drug development through the use of digital technologies and artificial intelligence.
Boehringer Ingelheim on Monday revealed new Phase II data for its investigational GLP-1/glucagon receptor dual agonist survodutide, showing that it could elicit significant improvements in patients with metabolic dysfunction-associated steatohepatitis.
The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.
The European Medicines Agency has recommended expanding Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvytki (ciltacabtagene autoleucel) for use as an earlier treatment in patients with relapsed or refractory multiple myeloma, Legend announced on Friday.
Roche on Sunday released results from the first stage of the Phase III OUtMATCH study, demonstrating that its asthma drug Xolair (omalizumab) can significantly reduce severe allergic reactions in patients with several food allergies.