Biogen/UCB’s Lupus Drug Shows Consistent Efficacy Across Endpoints, Over Time

Second Phase III Trial To Begin This Year

Detailed results for CD40L inhibitor dapirolizumab pegol showed consistent improvements over time with meaningful gains over placebo across all endpoints in its first Phase III study.

Dapirolizumab pegol showed efficacy across various components of SLE disease activity (Shutterstock)

Biogen and UCB may have a differentiated treatment for systemic lupus erythematosus (SLE) based on detailed results from the first Phase III clinical trial of the anti-CD40L antibody dapirolizumab pegol, which consistently separated from placebo with efficacy improving over time across multiple endpoints, including reduced disease activity, less frequent lupus flares and decreased steroid use.

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Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.

Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
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Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.

Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Roche’s Brain Shuttle Delivers In Alzheimer’s, Moves Ahead To Phase III

 

By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.

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What Is Fuelling Cell And Gene Therapies In India?

 
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Bharat Biotech is the latest entrant in India’s cell and gene therapy (CGT) space, joining majors like Intas Pharma, Sun Pharma, Cipla and Dr. Reddy’s. An indigenously developed CAR-T cell therapy launched last year, what is driving growing interest and success in cell and gene therapies?

Quick Listen: Scrip’s Five Must-Know Things

 
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In this week's episode: pharma dodges tariffs for now; Marks’s departure from FDA rattles industry; Phase 2b win for AstraZeneca’s oral PCSK9; Hengrui renews global Phase 3 push; and Novo’s new cardio results for semaglutide.