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
Hansa Biopharma has announced positive topline results from a study investigating Idefirix (imlifidase) in patients who have undergone HLA-incompatible kidney transplantation. The biopharmaceutical company announced the primary objective of the post-authorisation efficacy study (PAES) was met, with 90% of highly sensitised kidney transplant patients achieving one‑year graft failure‑free survival – following Idefirix pre‑treatment to convert… Read More
Now that this industry is seriously looking to advanced automation to reinvent the work it does, the data transformation imperative has soared back up the strategic agenda, says Ian Crone, ArisGlobal’s VP Europe & APAC Regulatory Solutions. Here, he reports on an impassioned panel debate that took place as part of the Life Science AI Exchange Podcast last year. The panel included subject… Read More
The European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Minjuvi (tafasitamab) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). The positive opinion was issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The opinion is based… 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
AstraZeneca and Amgen’s drug Tezspire (tezepelumab) has been recommended for approval in the European Union for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on… Read More
An opinion by Dr Ioannis Papasotiriou. This article is sponsored by RGCC International. How is a new drug developed in oncology? While this may seem like a simple question, it is important to recognise that the process is far more complex than it initially… Read More
This is the latest episode of the free DDW narrated podcast, titled “How to streamline regulatory approval”, which covers two articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. They are called: Quicker time to regulatory submission through improved data management and The… Read More
The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended 14 medicines for approval at its July 2024 meeting. However, the CHMP recommended not granting a marketing authorisation for Leqembi (lecanemab) for the treatment of Alzheimer’s disease. The committee said… Read More
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… Read More
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)… Read More
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… Read More
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… Read More
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… Read More
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… Read More
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… Read More
