European Medicines Agency has issued marketing authorisation for Orexo and MundiPharma’s Zubsolv for opioid dependence. Zubsolv is a once-daily, sub-lingual formulation of Suboxone (Buprenorphine/Naloxone), which is marketed by Invidior UK in Europe. It will be the first therapy of its kind to be approved in a choice of six different strengths in region, offering the
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Regulatory Professionals is one of the fastest growing global integrated regulatory outsourcing providers with a network of 20,000 pharmaceutical professionals globally. Working exclusively within the regulatory functions of Pharmaceutical, Biotechnology, Medical Device, Consumer health / OTC and Diagnostics industries.
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Boehringer Ingelheim has recently won its first biosimilar approval in Europe with authorisation of Cyltezo for a variety of chronic inflammatory conditions, which includes rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Cyltezo is a biosimilar of AbbVie’s Humira, an anti-TNF monoclonal antibody that pulls in annual sales of approximately $15 billion across its
Merck’s Mavenclad is being backed by NICE as an option for treating highly active multiple sclerosis in adults on the NHS. In a Final Appraisal Determination, the cost watchdog is recommending routine funding for the drug if the patient has rapidly evolving severe relapsing-remitting multiple sclerosis, that is, at least two relapses in the previous