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The pivotal ConfIdeS study has finished enrollment and is now with the FDA. IdeS is imlifidase, with the brand name Idefirix. It has been conditionally approved by EMA and is on the market in Europe since 2020. Idefirix is a niche product, an orphan drug. It is a cysteine protease Continue reading Idefirix PDUFA Date and the IdeS of March
Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to a single-digit factor. In other words, as more data accrue, Continue reading The Letermovir Top-Line Results are Out – Or Are They?
A Phase 1 study evaluating tigecycline (Tygacil®) to treat refractory Acute Myeloid Leukemia is currently underway? [1] Niacin extended release tablets (nicotinic acid, Niaspan®) was associated with a significantly higher rate of infections (appendicitis, bronchitis, cellulitis) compared to placebo in the AIM-HIGH trial which enrolled over 3400 patients? [2] Macrolides Continue reading Did you know that…