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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.
After winning a surprise approval for its hereditary angioedema drug Ekterly, KalVista is confident the oral offering will capture the lion’s share of the market for on-demand use.
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It doesn’t matter how many times you have traversed Union Square; no one knows which way is north, or where The Westin is in relation to the Ritz Carlton. A Verizon outage brought that into focus on Wednesday.
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The newest company by the life sciences venture capital firm, Prologue Medicines will search through the vast viral proteome to identify proteins with therapeutic potential.
With a total revenue of nearly $2.7 billion, Vertex exceeded analyst estimates in the first quarter, bolstered by strong uptake of its cystic fibrosis products.
ADC Therapeutics is positioning Zynlonta for a label expansion with new Phase II data showing that the treatment can elicit high rates of complete response in patients with relapsed or refractory marginal zone lymphoma.
In a joint conference event on Monday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
BioSpace will be in attendance at the American Society of Gene & Cell Therapy’s 27th annual meeting, along with thousands of others. Stay with us for updates throughout the week.
Cell and gene therapy company Cellectis announced Monday it has completed a $140 million investment from AstraZeneca that extends the biotech’s cash runway into 2026.
The Italian pharma will gain access to Gossamer Bio’s candidate seralutinib, which reached its primary endpoint in a Phase II pulmonary arterial hypertension trial in 2022 and started a Phase III study last year.
Reeling from “endemic-level demand” for its COVID-19 vaccine, BioNTech on Monday reported a steep decline in revenues and a loss per share that fell short of analysts’ consensus estimates for the first quarter of 2024.
Following the regulatory victory of Balversa in urothelial carcinoma, Johnson & Johnson on Friday continued its bladder cancer winning streak with an 82.8% complete response rate forTAR-200 in high-risk non-muscle invasive bladder cancer.