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Biologics for bowel disease face threat from cheaper small molecules

Drug Discovery World

The total sales of inflammatory bowel disease (IBD) drugs are estimated to reach approximately $10.2 In 2007, AbbVie’s Humira received approval from the FDA to treat moderate-severe Crohn’s disease (CD). The post Biologics for bowel disease face threat from cheaper small molecules appeared first on Drug Discovery World (DDW).

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Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease

The Pharma Data

BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s disease Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRRK2 inhibitor. Denali Therapeutics Inc.

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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients

The Pharma Data

“These positive results demonstrate that etrasimod, if approved, could be a potential breakthrough option for patients with ulcerative colitis who aren’t able to experience improvement on current therapies,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. About Etrasimod.

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Pfizer Completes Acquisition of Arena Pharmaceuticals

The Pharma Data

Acquisition offers new, differentiated, and potentially best-in-class approach to address needs of a broader number of patients with immuno-inflammatory diseases. In particular, we’re hopeful that we can accelerate clinical development of etrasimod successfully to have a positive impact on those living with these debilitating diseases.”.

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Pfizer Announces Positive Top-line Results from Yearlong Phase 3 Trial of Etrasimod in Ulcerative Colitis, Underscoring Best-in-Class Potential

The Pharma Data

The global Phase 3 multi-center, randomized, double-blind, placebo-controlled study enrolled 433 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Participants received etrasimod 2 mg or placebo once-daily. Pfizer Inc.:

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Lineage Cell Therapeutics Provides End of Year Shareholder Letter

The Pharma Data

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.