Clinical / R&D
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Latest From Research & Development
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.
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.
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.
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.
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 The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.
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.
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