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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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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
• By Michael McCaughan

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

EMA Says ‘No’ To Roche/Sarepta’s DMD Gene Therapy Elevidys

 
• By Eliza Slawther

The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.

More from Pathways & Standards

EMA Says ‘No’ To Roche/Sarepta’s DMD Gene Therapy Elevidys

 
• By Eliza Slawther

The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.

US FDA Commissioner Makary Is Learning To Appreciate His Staff

 
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After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.