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Aug 05, 2026
Xolair may be dropped from Medicare price negotiations as a biosimilar launch looms. The CMS must decide if the biosimilar is a true competitor. The outcome could set precedent for future biosimilar-facing selections.
Aug 01, 2026
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
Jun 11, 2026
Recent research identifies hidden systemic inflammation in primary ciliary dyskinesia via oral swab and confirms asthma biologics do not increase respiratory infection risk in pediatric patients.
May 12, 2026
Two studies examined blood biomarkers for omalizumab response in chronic spontaneous urticaria. Basophil histamine content did not predict response, while higher baseline monocyte counts were linked to complete remission in a 52-patient retrospective analysis.
Apr 28, 2026
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Mar 09, 2026
Pfizer's tilrekimig met its primary endpoint in a mid-stage eczema trial and will advance to late-stage testing. Separately, oral remibrutinib demonstrated rapid efficacy in treating peanut allergy in a phase II study.
