MaaT Pharma has received a negative trend vote from the Committee for Medicinal Products for Human Use (CHMP) for MaaT013 (Xervyteg) following re-examination for its conditional marketing authorisation application. The committee’s concerns relate primarily to the attribution of clinical benefit and safety in the absence of a… Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a cream to treat atopic dermatitis (AD). Opzelura (ruxolitinib) cream, developed by Incyte International for the treatment of moderate atopic dermatitis (AD), has been recommended for adult patients for whom topical corticosteroids… Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a treatment for severe alopecia. The recommended approval of upadacitinib is for the treatment of adult and adolescent patients with severe alopecia areata (AA), an unpredictable autoimmune disease causing a… Read More
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for Novartis’ Itvisma (intrathecal onasemnogene abeparvovec). The opinion supports its use for the treatment of children two years and older, teens, and adults… Read More
The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW’s Bruno Quinney narrates five key stories of the previous week to keep DDW subscribers up-to-date on the latest industry news. Last week, figures showed the number of women in biotech leadership has stalled. Elsewhere, could… Read More
The European Medicines Agency (EMA)’s Committee for Medicinal Products (CHMP) has adopted a positive opinion recommending marketing authorisation for a chronic spontaneous urticaria (CSU) treatment. The opinion means remibrutinib, a highly selective oral BTKi developed by Novartis, could be the first targeted therapy approved for CSU in Europe. … Read More
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended Zynyz (retifanlimab) for the treatment of anal cancer. Zynyz, developed by biopharmaceutical company Incyte, has received the EMA’s positive opinion to treat recurrent squamous cell carcinoma of the anal cancer (SCAC) in combination with… Read More
UCB’s Kygevvi (doxecitine and doxribtimine) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorisation under exceptional circumstances. The recommendation is for the treatment of paediatric and adult patients with genetically confirmed thymidine kinase… Read More
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy). If it is approved by the European Commission it will be the first… Read More
Johnson & Johnson’s Akeega (niraparib and abiraterone acetate dual action tablet) could soon be available to EU patients with metastatic hormone-sensitive prostate cancer with BRCA1/2 mutations, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The recommendation is for niraparib and abiraterone… Read More
GSK has announced positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of two new potential medicines for respiratory diseases. Depemokimab has been recommended as add-on maintenance treatment for severe asthma with type 2 inflammation (12+) and… Read More
The European Medicine Agency (EMA) has issued a positive opinion to support the approval of Veyvondi (vonicog alfa) to treat haemorrhages in children with von Willebrand disease (VWD). Veyvondi has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The CHMP issued the opinion for… Read More
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Tevimbra (tislelizumab) for resectable non-small cell lung cancer (NSCLC). It is recommended in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for… Read More
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting conditional marketing authorisation for Zemcelpro (UM171 cell therapy). The positive opinion relates to the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem… Read More
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the conditional marketing authorisation of the EU’s first HER2-targeted therapy for biliary tract cancer (BTC). Zanidatamab is an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody. … Read More
AstraZeneca’s Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment,… Read More
