In Depth 1 Aug 2025 Oncolytic virus therapy for cancer: what’s been going on in 2025? This past year has seen various developments in the field of oncolytic virus therapies – in fundraising and in the clinic. August 1, 2025 - 9 minutesmins - By Roohi Mariam Peter Share WhatsApp Twitter Linkedin Email
News and Trends 11 Sep 2024 Can Europe revive its biopharma innovation leadership? Find out if the biotech runner-up, Europe, can step up to boost research and revive its innovation leadership. September 11, 2024 - 9 minutesmins - By Jules Adam Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jan 2023 EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease BioArctic AB’s partner Eisai says the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab. Lecanemab, known as LEQEMBI in the U.S., is an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed […] January 27, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jan 2023 Dupixent gets EU nod for children with severe atopic dermatitis The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children six months to five years old who are candidates for systemic therapy. The European Commission is expected to announce a final […] January 27, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 26 Jan 2023 Milestone for gene-edited therapy for sickle cell disease Vertex Pharmaceuticals (Europe) and CRISPR Therapeutics have announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application of exa-cel for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The submission is supported by two global phase 3 studies investigating exa-cel as a potential one-time therapy for people with […] January 26, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Jan 2023 Janssen looks for talquetamab marketing approval The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug […] January 3, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 16 Dec 2022 CSL closer to gene therapy treatments for hemophilia B patients in Europe CSL says the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) of etranacogene dezaparvovec. Etranacogene dezaparvovec is a one-time gene therapy for the treatment of appropriate adults with hemophilia B that reduces the rate of annual bleeds with a single infusion. […] December 16, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
In Depth 15 Dec 2022 To avoid stagnation, the EU must refine its ATMP regulation Over the decades, the EU has spearheaded the adoption of advanced therapy medicinal products (ATMPs) such as cell and gene therapies. However, changes are needed to ATMP regulations to keep Europe competitive with the rest of the world. The EU has a rich resource base in terms of biotech innovation. Over the last decades, this […] December 15, 2022 - 8 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 15 Dec 2022 EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation Myrtelle Inc., a clinical stage gene therapy company, has announced that the European Medicines Agency (EMA) has granted orphan drug (OD) designation for rAAV-Olig001-ASPA, the company’s lead gene therapy product candidate for the treatment of Canavan disease (CD). EMA OD designation’s aim is to encourage the development of treatments for life-threatening rare conditions by providing […] December 15, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 5 Dec 2022 Positive antibody persistence for vaccine treating mosquito disease A single shot vaccine for mosquito-borne disease chikungunya has had positive antibody persistence data 12 months after vaccination. The primary endpoint also met with a 99% seroresponse rate. The disease is caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Following positive immunogenicity and safety data from a phase 3 study […] December 5, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
More News! 30 Nov 2022 FDA grants Sensorion Orphan Drug Designation for hearing loss drug Sensorion a clinical-stage biotechnology company has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to OTOF-GT, its lead gene therapy program for hearing loss. The drug is intended for the treatment of otoferlin gene mediated hearing loss. Sensorion is on track to file a clinical trial application (CTA) […] November 30, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 18 Nov 2022 AstraZeneca and Daiichi Sankyo’s Enhertu recommended for approval AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) for patients previously treated HER-2 positive advanced gastric cancer. The drug is also used for gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca […] November 18, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email