Immunology
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Prometheus Phase II Data For Novel TL1A Inhibitor Impresses On Efficacy
The company plans to move PRA023 forward into Phase III studies based on positive Phase II safety and efficacy data in UC and Crohn's disease, positioning Prometheus in a race with Roivant.
Pfizer Returns To Roivant As Development Partner For A Second Time
Roivant will form a new "vant" company to develop and commercialize Pfizer's TL1A inhibitor for ulcerative colitis.
Two Korean Pharmas Vie For Wins In High-Need Gout Space
Based on promising Phase II data, two companies in South Korea are moving ahead with late-stage development in the gout space, with JW Pharmaceutical getting approvals to begin a multinational Phase III trial for epaminurad, while LG Chem has recently submitted an application for a Phase III program with its contender tigulixostat.
AbbVie's Skyrizi Adds Crohn's Disease Indication In Europe
Skyrizi is the first specific IL-23 inhibitor for the treatment of Crohn's disease in Europe, though the drug was approved with a broader label in the US.
UCB Makes Another Push To Get Bimzelx Over Finishing Line In US
The Belgian group was stunned by an FDA rejection in May for its dual IL-17A and IL-17F inhibitor and although the refiling is complete, UCB may still have to wait six months to get Bimzelx into the all-important US psoriasis market.
IBD Market Snapshot: Payers May Shift Preferred Products To Accommodate New Drugs
Multi-product players may be able to use bundled rebates for preferred formulary status and biosimilars offer a new competitive dynamic, but there is hope for novel therapies.
IBD Market Snapshot: New Medicines Try To Address Patient, Physician Demands
Remission rates with existing therapies leave much room for improvement, so a variety of treatments are needed – leaving major players attempting to carve unique paths in a crowded market.
IBD Market Snapshot: Changes Ahead, But Current Biologics Are Formidable Competitors
The ulcerative colitis and Crohn’s disease landscapes may shift soon but new drugs will compete with entrenched blockbusters, including Humira, Stelara and Entyvio, with biosimilars on the way.
Looking To Learn From Past Failures, Galapagos Pivots To Immunology And CAR-T
The company has admitted making mistakes in its R&D, but must now convince investors that its new multi-modality approach will pay off.
Amgen Does Not Expect Big Enbrel Price Impact From US Humira Biosimilar Launches
Amgen will be first to launch a Humira biosimilar in the US with its Amgevita, but it and other adalimumab copies may add pressure to the company’s already declining top-seller Enbrel.
With $120m, HI-Bio Aims To Rapidly Prove Approach To Immune-Mediated Diseases
Human Immunology Biosciences (HI-Bio) launched with $120m and two candidates from MorphoSys, including the CD38 inhibitor felzartamab already in the clinic for immune-mediated kidney diseases.
GSK To Take ‘Smart Risks’ Across Portfolio – But Will Be ‘Pragmatic’ About Oncology Expansion
GSK’s new R&D leader, Tony Wood, has promised a more hard-nosed attitude to picking winners – including a ‘pragmatic’ approach to the hyper-competitive field of oncology.
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