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Novartis Reports P-III (RemIND) Trial Data on Remibrutinib for Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial showed higher CR rates at Wk. 12 across symptomatic dermographism (29.3% vs 14%), cold urticaria (56.3% vs 14.6%), & cholinergic urticaria (29.3% vs 15.8%), with responses emerging as early as Wk.…
June 12, 2026

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GlycoNex Reports the P-III Trial Data on SPD8 (Biosimilar, Denosumab)

Shots: GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), a biosimilar version of denosumab co-developed with Mitsubishi Gas Chemical, vs Prolia in 266 Japanese subjects with osteoporosis Trial met its 1EP, with SPD8 demonstrating therapeutic equivalence to Prolia. The between-group difference in the 1EP & its 95% confidence interval fell within the pre-specified…
June 11, 2026

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Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis

Shots: The US FDA has approved Ebglyss (lebrikizumab-lbkz; 250mg/2mL, Q8W, SC) maintenance therapy for the treatment of pts (≥12yrs.; ≥40kg) with mod. to sev. atopic dermatitis Approval was supported by longitudinal exposure-response modeling & Q8W dosing data from an extension of the P-III (Adjoin) long-term trial, which assessed Ebglyss maintenance dosing for Q4W or Q8W over…
June 10, 2026

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Incyte to Acquire Vega Therapeutics for ~$2B

Shots: Incyte has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, to expand its hematology portfolio into bleeding disorders As per the deal, Incyte will acquire Vega for $1.25B upfront, with ~$750M in additional payments upon achievement of sales milestones Acquisition will expand Incyte’s hematology portfolio with…
June 8, 2026

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Chiesi Reports the EC Approval of Lojuxta to Treat Homozygous Familial Hypercholesterolaemia in Pediatric Patients

Shots: The EC has approved Lojuxta (lomitapide capsules) for the treatment of children (≥5yrs.) with Homozygous Familial Hypercholesterolaemia (HoFH), alongside diet & other lipid-lowering treatments, incl. LDL-apheresis Approval was based on the P-III (APH-19) trial evaluating Lojuxta in 43 pediatric pts (5 to 17yrs.) with HoFH Trial met its 1EP, showing a mean 53.5% reduction…
June 5, 2026

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Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka reported the ongoing P-III (VISIONARY) trial data assessing Voyxact (sibeprenlimab; n= 320) vs PBO (n=152) in preserving kidney function in IgAN pts over a 24mos. treatment period At 12mos., Voyxactimproved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², achieving the KDIGO treatment goal of limiting annual kidney…
June 5, 2026

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