Hypogonadism Trial Designs: FDA Panel Favors Symptom Assessments, Fertility Measures
US advisory committee rejects Repros Therapeutics' proposal for an obesity-related hypogonadism study in which efficacy is based upon testosterone levels and sperm concentrations.
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Draft is intended to inform development of non-testosterone products such as aromatase inhibitors or estrogen receptor agonists.
Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will likely shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.
Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon.