EMA approve opioid dependence therapy

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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Boehringer gains first biosimilar approval within EU for Cyltezo

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

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Gilead gains EU approval for Hep Combination Treatment – Vosevi

Gilead Sciences obtained a big achievement with its Hepatitis C treatment Vosevi (drug which comprises of Sofosbuvir/Velpatasvir/Voxilaprevir) becoming the first and only single tablet regimen for patients who have previously failed therapy with direct-acting antivirals (DAA). The drug was approved to treat adults with genotype 1-6 chronic hepatitis virus (HCV) infection as a 12-week regimen

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Astellas AML treatment receives fast track designation from FDA

Astellas Pharma has received fast-track designation in the US for its FLT3 inhibitor, Gilteritinib, a drug that could potentially rival Novartis’ budding $250m-plus product Rydapt (Midostaurin). The FDA gave the status to Gilteritinib as a treatment for adults with FLT3-mutation-positive relapsed or refractory acute myeloid leukaemia (AML), a cancer that impacts blood and bone marrow.

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Fast track designation given to Shire’s chronic lung disease drug by FDA

The Food and Drug Administration has approved Fast Track designation for Shire’s SHP607, a treatment used in the prevention of chronic lung disease in extremely premature infants. SHP607, which is currently in Phase 2 Clinical Development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its

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