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
Merck Sharp & Dohme’s Keytruda has received approval in Europe for metastatic urothelial carcinoma allowing it to catch up with its immunotherapy rivals. Although, while BMS’ Opdivo and Roche’s Tecentriq beat MSD to approval in Europe earlier this year, Keytruda is the first treatment to show superior overall survival when compared to using chemotherapy in
European regulators have approved Gedeon Richter’s novel antipsychotic Reagila as a new option for the treatment of patients with schizophrenia. In clinical trials the drug, a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic, significantly improved symptoms of the condition and reduced the risk of relapse by 55% when compared to the placebo.
EU regulators have issued approval for the first immunotherapy for high-risk neuroblastoma, which will offer a new treatment option to thousands of children affected by the rare and devastating form of cancer. EUSA Pharma’s dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen (GD2) on neuroblastoma cells, now indicated to treat
Ferring’s Rekovelle has been approved by European regulators for controlled ovarian stimulation in women undergoing assisted reproductive technologies. The firm says Rekovelle is the first recombinant follicle stimulating hormone (rFSH) to be derived from a human cell line and is the first rFSH treatment to be administered with an individualised dosing regimen, based on a
