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No Sweat – Hyperhidrosis Patients Seek Broader Approvals; Botox Access An Issue

 
• By Kate Rawson

US FDA not looking to reduce attendance at third-party patient meetings, which deliver 'bang for the buck.' Excessive sweating is first externally led PFDD meeting for a more common condition.

Female athletes running towards finish line on track field

Drug sponsors interested in hyperhidrosis research and development should focus on treatments that are effective for all types of excessive sweating – not just underarm or foot/hand sweating, according to patients participating in a patient-focused drug development meeting hosted by the International Hyperhidrosis Society in Washington, DC on Nov. 13.

While there are treatments for hyperhidrosis approved by the US FDA – like Botox injections and DrySol prescription antiperspirant –...

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New EU Approvals

 
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Rezdiffra, Madrigal Pharmaceuticals’s treatment for metabolic dysfunction-associated steatohepatitis.

Navigating Rare Disease Submissions: Minoryx Stresses Early EMA Engagement

 
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Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
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The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
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Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.

More from Pathways & Standards

Navigating Rare Disease Submissions: Minoryx Stresses Early EMA Engagement

 
• By Manas Mishra

Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
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The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.