The company’s planned investment includes 450 million pounds to research, develop and manufacture vaccines at its manufacturing site in Speke, Liverpool, and another 200 million pounds to expand its existing presence in Cambridge, where its global headquarters are located.
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The past two years have seen a pair of new treatments approved for a particularly intractable neurodegenerative disease —amyotrophic lateral sclerosis. But while Amylyx’s Relyvrio and Biogen’s Qalsody have crossed the FDA finish line, others have stumbled in a regulatory space that experts say is still evolving.
Akero Therapeutics’ drug to treat a type of fatty liver disease helped significantly reduce scarring after nearly two years in a study, it said on Monday, as the company targets a potential multi-billion-dollar market.
Agency inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters.
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.
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.