Pfizer’s drug Velsipity (etrasimod), for the treatment of moderate to severe ulcerative colitis (UC), recently received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Biora Therapeutics recently announced the initiation of phase 1 clinical trials of BT-600, a novel drug-device combination for ulcerative colitis (UC) patients.
Eli Lilly has announced that the National Institute for Health and Care Excellence (NICE) has recommended mirikizumab for the treatment of adults with moderately to severely active Ulcerative Colitis (UC).
Xbiome Inc, a China headquartered AI-based microbiome therapeutics startup, has acquired the clinical-stage M201 program developed by Assembly Biosciences, a firm developing therapeutics targeting hepatitis B virus and other viral diseases.
Takeda has partnered with Portal Instruments to develop a needle-free drug delivery device for biologic medicines, starting with the former’s Entyvio (vedolizumab).
Fears of Remicade competition have not manifested in significant growth declines for Johnson & Johnson, but Pfizer says US payers and physicians are slowly getting comfortable with biosimilars.
A US FDA advisory committee has voted overwhelmingly in favour of licensing Celltrion and Pfizer’s version of J&J’s Remicade, paving the way for the first US monoclonal antibody biosimilar.
Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
Encap Drug Delivery now offers a ‘feasibility package’ to assess the potential of its Phoral coating technology as a vehicle for therapy in colonic diseases.