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Biologics for bowel disease face threat from cheaper small molecules

Drug Discovery World

Adeleke Badejo, Senior Analyst of Immunology at GlobalData, commented: “Barriers to US market growth will primarily result from the loss of patent exclusivity of current biologics, and the subsequent entry of biosimilars to these reference therapies. Fortunately, this will force innovation by companies that seek to enter this space.”

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Navigating FDA User Fee Updates for Fiscal Year 2023

thought leadership

Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices.

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

The Pharma Data

“More than 10 million people worldwide are affected by Parkinson’s disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease,” said Carole Ho, M.D., BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali.

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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.

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Pfizer Completes Acquisition of Arena Pharmaceuticals

The Pharma Data

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

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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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