NICE has announced its final draft guidance recommending avatrombopag for routine use on the NHS in England and Wales for the treatment of thrombocytopenia in chronic liver disease patients who require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
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.
Novartis has announced they have received EC approval for Beovu, an injection for the treatment of wet age-related macular degeneration (AMD). Novartis also stated that the therapy is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid, which is a key marker of disease activity, compared to Bayer’s Eylea in the trial’s
FDA has agreed to fast-track its regulatory review of Novartis’ capmatinib in a hard-to-treat form of lung cancer. Novartis said it has applied for capmatinib, developed in partnership with Incyte, to be marketed as a MET inhibitor for first line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated
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
BioIntelliSense has secured clearance from the FDA for its biosticker sensor for remote care. The sensor is an advanced body sensor which enables continuous monitoring of vital signs and insights. It helps clinician’s access data from patients at home and helps with detections of complications early. BioIntelliSense collaborated with UCHeatlth and its CARE Innovation Center
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),
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
Regulatory Professionals, part of the Clinical Professionals Group would like to wish everyone a Merry Christmas and a Happy New Year. Regulatory Professionals offices will be closed from on the 25th of December and will reopen on Thursday 2nd January. We are proud to say that Regulatory Professionals has had a fantastic and eventful year!
Those living in Scotland with the rare blood cancer polycythaemia vera (PV) will soon gain access to a new treatment option on the NHS after cost regulators approved funding for Novartis’ Jakavi (ruxolitinib). The drug can be used on the NHS to treat adults with polycythaemia vera (PV) who are resistant to, or intolerant of, hydroxyurea