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Clinical / R&D

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Latest From Research & Development

KemPharm Taking Ritalin Prodrug Into Phase III For ADHD

Months after reaching agreement with FDA to refile the NDA for its abuse-deterrent opioid Apadaz, KemPharm has gotten the okay to take its prodrug of Ritalin into Phase III for ADHD.

Clinical Trials Drug Review

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

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.

Drug Approval Standards Dermatology

US FDA Gives Sponsors Some Leeway In Studying Drug Effects On Driving

Final guidance on evaluating drug effects on ability to operate a motor vehicle has been slightly modified in response to suggestions by Eisai, Pfizer and Merck.

Drug Safety Neurology

PTC Readies China Plan Amid US FDA Translarna Setback

PTC is engaging physicians and Duchenne muscular dystrophy patients in China to access a largely untapped market but regulatory and reimbursement-related uncertainties could pose challenges.

Clinical Trials Rare Diseases

CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin

At its November meeting, the CHMP finally OKd Roche's Ocrevus for multiple sclerosis and gave the green light to new drugs for eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as Amgen’s Mvasi, the first EU biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.

Drug Review Europe

New EU Guidance To Boost Development Of Vaccines And Treatments For RSV Infections

Companies wanting more guidance on how to go about developing new vaccines and treatments for respiratory syncytial viral infections will be interested in a new document that has just been put out for consultation by the European Medicines Agency.

Vaccines Infectious Diseases
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