NICE recommends new thrombocytopenia in chronic liver disease treatment

NICE has announced its final draft guidance recommending avatrombopag for routine use on the NHS in England and Wales for the treatment of thrombocytopenia in chronic liver disease patients who require surgery. Avatrombopag has been shown to elevate platelet levels for longer periods than platelet transfusions. The recommendation provides patients with a new treatment option

Continue Reading

EMA and FDA both accept application filing of Novartis’ RMS treatment

FDA and EMA have accepted its Supplemental Biologics License Application (sBLA) and Marketing Authorisation Application (MAA), for ofatumumab, formerly known as OMB157. The fully human anti-CD20 monoclonal antibody, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, is a novel B-cell therapy that delivers sustained efficacy with a favourable safety profile.

Continue Reading

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

Continue Reading

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),

Continue Reading

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

Continue Reading