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Features & Analysis

UCB’s CIMZIA breakthrough designation targets the placenta, not the clot. Is that the key to high-risk APS pregnancy?

The FDA has granted Breakthrough Therapy Designation to UCB’s CIMZIA for high-risk pregnant women with antiphospholipid syndrome after Phase 2 evidence suggested that adding TNF inhibition to standard aspirin and heparin could reduce severe placenta-mediated complications. The programme challenges a long-standing assumption that preventing thrombosis alone is sufficient to manage obstetric APS.

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Pharma & Biotech

UCB gets FDA Breakthrough Therapy designation for certolizumab pegol in high-risk APS pregnancy

FDA grants UCB Breakthrough Therapy status for certolizumab pegol in high-risk APS pregnancy, based on promising but non-randomized Phase 2 evidence.

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Pharma & Biotech

Antengene brings first ATG-207 preclinical data to EULAR 2026 as autoimmune focus deepens

Find out how Antengene’s ATG-207 data could shape autoimmune drug development as CD3 and TGF-beta fusion biology enters focus.

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Pharma & Biotech

Can UCB’s $2.2bn Candid Therapeutics deal reset the future of autoimmune therapy?

UCB is paying heavily for early autoimmune science. Candid tests whether T-cell engagers can move beyond oncology into immune reset.

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Medical Devices & Diagnostics

What KORU Medical’s RYSTIGGO delivery clearance means for subcutaneous infusion models

KORU Medical’s FreedomEDGE gets FDA clearance for RYSTIGGO delivery in clinics. Find out how this expands access to gMG therapy and reshapes infusion workflows.

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Pharma & Biotech

How Staccato technology positions Lee’s Pharmaceutical for CNS drug delivery leadership

Lee’s Pharmaceutical Holdings Limited has acquired the Staccato One Breath Technology platform and related assets from Alexza Pharmaceuticals, gaining exclusive rights to manufacture and license Staccato alprazolam under its global agreement with UCB. The transaction expands Lee’s Pharmaceutical’s inhalation drug delivery pipeline, deepens its foothold in central nervous system therapies, and positions the company to

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