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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
352 Results
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FDA
Amgen Contests J&J’s Stelara with FDA Approval for Interchangeable Biosimilar
Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.
November 2, 2023
·
3 min read
·
Tristan Manalac
FDA
Merck’s Keytruda Plus Chemo Secures FDA Approval for Biliary Tract Cancer
The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine. It’s the sixth indication in gastrointestinal cancers.
November 2, 2023
·
2 min read
·
Tyler Patchen
Drug Development
Study Highlights Standout Clinical Success of Certain Cell and Gene Therapies
A recent report by Tufts Medical Center reveals impressive approval rates for durable cell and gene therapies, but experts urge caution over persistent safety and accessibility concerns.
November 2, 2023
·
5 min read
·
Aayushi Pratap
FDA
Novartis Adds Hidradenitis Suppurativa to Cosentyx’s Label in Challenge to Humira
The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.
November 2, 2023
·
2 min read
·
Tristan Manalac
Business
Novo Logs Over 700% Wegovy Sales Growth in Q3, Raises 2023 Outlook
Riding a wave of skyrocketing Wegovy and Ozempic sales, the company on Thursday raised its sales and operating profit outlook for the rest of the year as part of its third-quarter earnings announcement.
November 2, 2023
·
2 min read
·
Tristan Manalac
Business
Lilly’s Mounjaro Beats Q3 Expectations, But Company Cuts Full-Year Profit Guidance
Sales of type 2 diabetes treatment Mounjaro brought in $1.4 billion in the third quarter. However, the company cut its full-year profit guidance due to charges mainly related to recent acquisitions.
November 2, 2023
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1 min read
·
Kate Goodwin
Business
Moderna Posts Q3 Loss, Takes $1.3B in Write-Downs on COVID-19 Shots
While Moderna’s total revenue for the third quarter beat analyst expectations, the company Thursday reported a loss as demand for its COVID vaccines declined.
November 2, 2023
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2 min read
·
Tyler Patchen
Business
Baxter Reports Third-Quarter 2023 Results
Baxter International Inc., a global medtech leader, reported results for the third quarter of 2023.
November 2, 2023
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21 min read
Policy
Prokarium Achieves Major Milestone with FDA’s IND Approval for Bladder Cancer Program
Prokarium announces that the U.S. Food and Drug Administration has granted the company’s Investigational New Drug application for their immunotherapy ZH9.
November 2, 2023
·
3 min read
BioCapital
Verana Health Partners with Foundation Fighting Blindness to Integrate Genetic Testing Data into Real-World Evidence Research
Verana Health® announce a partnership focused on providing the life sciences community with deeper and broader data to optimize and expedite clinical trials.
November 2, 2023
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5 min read
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