BioSpace News Archive

Business

Vertex Touts 13% Revenue Jump, Beats Profit Estimates on Strong Cystic Fibrosis Performance

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.

May 7, 2024
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2 min read
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Tristan Manalac
Drug Development

ASGCT24: Prime Medicine to Apply Gene Editing to Wide-Ranging Indications

The biotech touted its prime editing technology at ASGCT on Tuesday after receiving FDA clearance last week for a clinical study of a drug candidate based on the platform.

May 7, 2024
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2 min read
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Greg Slabodkin
FDA

Sarepta Seeks Label Expansion, Bigger Market for DMD Gene Therapy

As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy.

May 7, 2024
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4 min read
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Tyler Patchen
Drug Development

Preliminary Findings Point to Low Risk of Secondary Cancers from CAR-T Therapies

In a joint conference event on Monday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.

May 7, 2024
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2 min read
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Tristan Manalac
Drug Development

ADC Therapeutics Posts Early Phase II Lymphoma Data for Zynlonta as Revenue Drops 5.8%

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.

May 7, 2024
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2 min read
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Tristan Manalac
Policy

FDA Action Alert: Dynavax, Ascendis and BMS

The FDA is looking at four decision deadlines in the coming three weeks, including two for a CAR-T therapy and another for a hepatitis B vaccine.

May 7, 2024
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4 min read
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Tristan Manalac
Drug Development

ASGCT, Adcomm for Lilly’s Donanemab, Vertex Vs. Bluebird

AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.

May 7, 2024
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1 min read
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Jef Akst, Greg Slabodkin and Heather McKenzie
Business

Flagship-Backed Prologue Launches with $50M to DELVE into Viral Proteome

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.

May 7, 2024
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2 min read
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Tristan Manalac
Drug Delivery

AAV Manufacturing Takes Center Stage at ASGCT24

Tuesday afternoon’s session was standing room only as representatives from various biopharma companies presented on their work to improve the efficiency and quality of AAV production.

May 7, 2024
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2 min read
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Jef Akst
Drug Delivery

BMS, J&J Losses Not the End of IRA Legal Battle

With appeals and additional cases still pending, it remains to be seen if any of the arguments being brought by biopharma companies against the U.S. government will hold up in court.

May 7, 2024
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5 min read
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Roxanne Nelson