The U.S. FDA has approved Sanofi SA’s treatment for cold agglutinin disease (CAD), sutimlimab, after the drug was initially rejected by the regulator for technical reasons in 2020. Paris-based Sanofi’s drug will be branded as Enjaymo.
Two studies published this January by separate research teams have conclusively identified Epstein-Barr virus infection as the cause of multiple sclerosis, and the mechanism by which the immune response to EBV infection triggers an attack on the myelin sheath, the insulation that enables high-speed neuronal transmission.
UCB SA anticipates submitting regulatory applications in the third quarter for IL-17-targeting bimekizumab in psoriatic arthritis and ankylosing spondylitis, after chalking up second successful phase III trials in both indications. Meanwhile, the high commercial hopes for the would-be blockbuster remain at least temporarily deferred as pandemic-related travel restrictions have delayed FDA action on the BLA for plaque psoriasis.
PERTH, Australia – After raising AU$7.5 million (US$5.4 million) in a private placement, biopharma company Servatus Ltd. is advancing its microbial biotherapeutics clinical programs targeting serious autoimmune conditions. The Coolum, Queensland-based private company is focused on identifying and developing live microbial biotherapeutics and engineered proteins to treat chronic and autoimmune diseases, as well as non-antibiotic treatments for bacterial infections.
Astrazeneca plc has announced two significant R&D deals with Scorpion Therapeutics Inc. and Benevolentai Ltd., which it hopes will sharpen its research into cancer, lupus and heart failure. Both of the deals involve artificial intelligence (AI) as a way to increase the probability of success during the clinical development process and reduce the chances of costly trial failures.
Clinicians at the University of Maryland have transplanted a heart from a genetically modified pig bred by Revivicor Inc., a subsidiary of United Therapeutics Corp., into a patient with end-stage heart failure.
Making good on ambitions to increase its say in the development of drug candidates from its AI-driven discovery platform, as well as the breadth of roles the system serves, Exscientia plc said Jan. 7 it will work with longtime partner Sanofi SA to develop up to 15 new small-molecule candidates for oncology and immunology indications. Sanofi will pay Exscientia $100 million up front and up to $5.2 billion in total milestones, plus tiered royalties, it said.
A split decision from the U.S. Court of Appeals for the Federal Circuit could give Novartis AG’s blockbuster multiple sclerosis drug, Gilenya (fingolimod), a little more breathing room from unlicensed generics.
Argenx NV’s Vyvgart (efgartigimod), approved late Friday by the FDA for treating generalized myasthenia gravis, became the first FcRn antagonist to cross the finish line. But the best news may be the drug’s broad label, which company executives highlighted during an investor call.
Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants.