EMA

New trial evidence has shown that Kite’s CAR-T cell therapy Yescarta (axicabtagene ciloleucel: axi-cel) reduces the risk of death by 27.4% in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), corresponding to a 38% improvement in overall survival (OS). It is the only treatment in nearly 30 years to show statistically significant OS, […]

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations, with disease progression during or […]

Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at AmerisourceBergen, and Cori Gorman, Senior Director of CMC and Regulatory Affairs at Biopharma Excellence, offer advice on navigating the different and sometimes contradictory regulatory requirements in the US and EU. Over the past few decades, the incredible progress in personalised medicine […]

Justin Hay, Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects.   It has been a very busy period recently for paediatric drug development with the release of many guidance documents from two notable regulatory agencies. […]

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorisation of JZP458 (a recombinant Erwinia asparaginase or crisantaspase). It has been recommended for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma […]

The EU Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for epcoritamab (Tepkinly) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The final European Commission decision on this […]

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Janssen’s Talvey (talquetamab). The drug has received a positive opinion for use as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three […]

The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting. The following novel medicines and biosimilars each received a positive opinion: Abrysvo (bivalent, recombinant), a vaccine to protect small infants and older people against lower respiratory tract disease caused by respiratory syncytial […]

The European Medicines Association (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. The paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning […]

The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s marketing authorisation application (MAA) for zolbetuximab, an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody. The application is for authorisation as a first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2-positive. Gastric cancer […]

Following the death of a cancer patient after they were given an unlicensed drug, Diana Spencer unpacks the practice of prescribing unlicensed and off-label medicines. This month, a cancer patient died and three others were hospitalised in the UK after they were administered an unlicensed version of the chemotherapy drug cabazitaxel. In a statement, the […]

The European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is reviewing data on the risk of suicidal thoughts and thoughts of self-harm related to GLP-1 receptor agonists. The drugs under review include Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide), used for weight loss and for treating type 2 diabetes. The review […]

Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of single tablet combination therapy (STCT) of macitentan and tadalafil for pulmonary arterial hypertension (PAH). The single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) is intended for the long-term treatment of pulmonary arterial hypertension (PAH, World […]

The European Medicines Agency (EMA) has granted PRIME (Priority Medicines) status to the gene therapy, GNT-0003, currently in clinical trials for Crigler-Najjar syndrome, a rare liver disease.   This status, granted only to drug candidates with major therapeutic potential, follows the successful completion of the first phases of the clinical trials.  The manufacturer, Genethon, is a […]

Robust digital workflows can reduce errors and time to compile data leading to greater transparency, faster reporting and help biopharmaceutical companies reach regulatory submission faster. Ken Forman, Senior Director of Product Strategy, IDBS explains. For many start-ups operating on limited investment capital, the ticking clock can be overwhelming. Teams must plan for post-approval activities while […]

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended not to grant marketing authorisation for Ipsen’s investigational palovarotene as a treatment for fibrodysplasia ossificans progressiva (FOP).   The company says it will be requesting a re-examination of the CHMP opinion, based on scientific data available from the existing […]