Drug Development
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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The Q1 results for Voxzogo gave BioMarin the confidence to raise its 2022 full-year guidance to between $100 million to $125 million (net product revenue) for the drug.
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Zentalis Pharmaceuticals announced that Pfizer made a $25 million equity investment in the company.
Exogene nets $2 million to propel the development of its AI platform for T-cell receptor discovery and Healome spins out to deploy a ‘pro-healing’ platform with a focus on ocular surface diseases.
AviadoBio is celebrating orphan drug designations from both the U.S. FDA and the European Commission for AVB-101, a gene therapy intended to treat frontotemporal dementia (FTD).
BeiGene’s candidate drug tislelizumab for cancer succeeded in meeting the primary endpoint of overall survival in a global Phase III trial. Learn more about it here.
The U.S. Congress is calling for the coronavirus management plan to deliberate on the timeline for the approval and release of vaccines for children under 5 years old.
New research suggests that treatment with anti-amyloid-beta protofibril antibody lecanemab is estimated to slow the rate of disease progression in patients with Alzheimer’s Disease.
GlaxoSmithKline exceeded expectations for its first-quarter sales and earnings forecasts. This was largely driven by its sales of Xevudy, an antibody treatment against COVID-19 it developed with Vir Biotechnology, and its Shingrix vaccine against shingles.
Cassava Sciences CEO Remi Barbier is hitting back at The New York Times, calling out the newspaper for an article that he claims misrepresented the research of his company.