Merck receives approval for Alzheimer’s label claim for insomnia drug

Merck & Co/MSD has claimed FDA approval for a new use of its insomnia drug Belsomra, treating sleep disruption in people with mild-to-moderate Alzheimer’s disease. Belsomra (suvorexant) has been approved since 2014 for treating insomnia in the general population characterised by difficulties with falling or staying asleep, becoming the first in a new class of drugs targeting

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EC approves Jazz Pharmaceutical’s narcolepsy and sleep apnoea treatment

Jazz Pharmaceuticals has received a European Marketing Authorisation for solriamfetoli as a treatment for excessive daytime sleepiness in adults with narcolepsy and obstructive sleep apnoea. The company announced that The European Commission (EC) has accepted the drug to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy as well as obstructive sleep apnoea (OSA),

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Minds are like parachutes; they work best when open – Read our latest Regulatory Affairs Report

The latest CPIA report features analysis and data from the Regulatory Affairs sector within the pharmaceutical industry for UK, Ireland, Germany, Switzerland, Belgium, Netherlands, and Luxembourg. Clinical Professionals Group CEO, Yvette Cleland comments: To view the full report and previous editions, please visit the CPIA report on the Clinical Professionals website here.  If you would

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FDA approves SK Biopharma’s seizure drug

FDA has given Arvelle Therapeutics’ Xcopri the go-ahead for partial-onset seizures in adults. The emerging company, which is part of a subsidiary of SK Biopharmaceuticals, announced that it has also licensed exclusive rights to develop and commercialise the drug in Europe, with intent to file a Marketing Authorisation Application (MAA) in the first half of

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