Category: Pharma News

  • EMA Validates Application for Tepotinib for Treatment of Advanced NSCLC

    Merck announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. With this validation, the application is complete, and the EMA will now begin the review procedure. […]

  • BMS Receives EC Approval for Opdivo

    Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy. The EC’s decision is based on results from the Phase 3 ATTRACTION-3 trial, a study sponsored by Ono Pharmaceutical Co., Ltd. […]

  • Novartis secures exclusive rights for ARDS cell therapy

    Novartis announced that it entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. ARDS is an area of significant unmet need, with an approximate 40% mortality rate with current standard of care, which […]

  • GSK starts phase 3 study of RSV vaccine

    GlaxoSmithKline plc announced that patient dosing has begun in a phase 3 clinical programme investigating the safety and efficacy of its Respiratory Syncytial Virus (RSV) candidate vaccine for maternal immunisation. RSV is a leading cause of respiratory infections such as bronchiolitis (inflammation and congestion of the small airways or bronchioles of the lung) and viral […]

  • EC Grants Marketing Authorization of Jyseleca for Arthritis

    Gilead Sciences, Inc. and Galapagos NV announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease […]

  • MTPC Launched Vafseo in Japan

    Mitsubishi Tanabe Pharma Corporation launched VAFSEO® Tablets 150mg and 300mg (VAFSEO®, vadadustat) whichis an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in-licensed from Akebia Therapeutics, Inc., for the treatment of renal anemia on August 26, 2020, in Japan following today’s inclusion of VAFSEO® in the NHI drug price listing. VAFSEO® (vadadustat), in-licensed from Akebia Therapeutics, […]


    Precision BioSciences, Inc., a clinical stage biotechnology developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, in collaboration with Servier, an independent global pharmaceutical company, today announced the companies have added two additional hematological cancer targets beyond CD19 and two solid tumor targets to its CAR T development and commercial […]

  • Larotrectinib new data shows long term efficacy in Cancer

    Updated clinical data for Vitrakvi™ (larotrectinib) reinforce the consistent and long-term efficacy as well as a favorable safety profile for the precision oncology drug in an integrated dataset of 175 adult and pediatric patients with tropomyosin receptor kinase (TRK) fusion cancer. In addition, new tumor-type specific sub-analyses in lung and thyroid cancer patients further emphasize […]

  • Olaparib recommended for approval in the EU for metastatic castration-resistant prostate cancer

    AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its […]

  • Alpelisib show survival benefit for patients with advanced breast cancer

    Novartis announced results of the final overall survival (OS) analysis from the SOLAR-1 trial, which evaluated Piqray® (alpelisib) in combination with fulvestrant, compared to fulvestrant alone, in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer patients with tumors harboring a PIK3CA mutation. Piqray is the only treatment approved in Europe, the […]