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.
EMA
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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 […]
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 […]
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 […]
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 […]
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. […]
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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 […]
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 […]
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 […]
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) […]
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 […]
More News! 14 Nov 2022
Minoryx and Neuraxpharm form alliance to get rights to new therapy for rare CNS disease
Minoryx Therapeutics and Neuraxpharm Group have announced a strategic alliance for the European rights to a new therapy for rare central nervous system (CNS) disease. The companies have entered into a license agreement for leriglitazone, currently under European Medicines Agency (EMA) review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD). Under the agreement, Minoryx grants Neuraxpharm […]
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