Clarus Therapeutics Inc. has won FDA approval for the first oral formulation of testosterone with the approval of Jatenzo (testosterone udecanoate), a testosterone replacement therapy for certain adult men with conditions associated with a deficiency or absence of endogenous testosterone.
Clarus Keeping Commercial Options Open For Oral Testosterone Jatenzo
Jatenzo – the first oral testosterone cleared by US FDA – will compete against injectable and topical formulas in a field that has suffered safety worries in the past. Clarus has a jump on oral rival Lipocine.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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The small interference RNA therapeutic can be used by patients regardless of inhibitor status.
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The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.
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After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.
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The small interference RNA therapeutic can be used by patients regardless of inhibitor status.
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Senior executives from AstraZeneca, BMS, Novo Nordisk, Takeda and Regeneron outline how big pharma's global capability centers (GCCs) in India are evolving beyond cost efficiency, focusing on innovation, “agile experimentation” and new technology including GenAI, virtual & augmented reality, with some positioned as COEs. Will Indian multinationals use the GCC approach?
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In this week's episode: Merck & Co. licenses Hengrui’s lipid lowerer; Novo gets United’s triple G obesity drug; J&J plans major US manufacturing investments; approval for GSK’s novel antibiotic; and a call for more aggressive Korean M&A activity.