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4,021 Results for "regeneron".
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Earnings
Regeneron Reports Mixed Q3 Sales as Eylea Franchise Remains Under Pressure
Despite disappointing third-quarter results for Regeneron’s high-dose Eylea injection, analysts continued to be cautiously optimistic about the company’s promising cancer, immunology and genetic medicines pipeline.
November 1, 2024
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2 min read
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Tristan Manalac
FDA
Sanofi and Regeneron’s Dupixent Snags First Biologic Approval in COPD
Already approved in six indications, Sanofi and Regeneron can now add chronic obstructive pulmonary disease to the list for their blockbuster injection.
September 27, 2024
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2 min read
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Kate Goodwin
Legal
Amgen Gets Legal Win in Eylea Patent Row With Regeneron
Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea.
September 24, 2024
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2 min read
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Tristan Manalac
Lymphoma
Regeneron Scores EU Lymphoma Approval for Bispecific Antibody Ordspono
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
August 27, 2024
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2 min read
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Tristan Manalac
Approvals
FDA Denies Approval of Regeneron’s Linvoseltamab for Multiple Myeloma, Cites Third-Party Issues
The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.
August 21, 2024
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2 min read
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Tristan Manalac
Cancer
BioNTech, Regeneron’s mRNA Cancer Vaccine Combo Clears Phase II in Melanoma
BioNTech and Regeneron will face off against Merck and Moderna, which are advancing their investigational cancer vaccine mRNA-4157/V940 in combination with Keytruda, in advanced melanoma.
July 30, 2024
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2 min read
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Tristan Manalac
Legal
Regeneron Sues Sandoz in Federal Court to Block Eylea Biosimilar
In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act.
August 29, 2024
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2 min read
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Tristan Manalac
FDA
FDA Greenlights Two Interchangeable Biosimilars to Regeneron’s Eylea
The regulator on Monday approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire.
May 21, 2024
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2 min read
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Tristan Manalac
Drug Development
ASCO24: Regeneron’s Bispecific Antibody Falls Flat in Early Study
Phase I/II data for Regeneron Pharmaceuticals’ costimulatory bispecific antibody were disappointing, with only one complete response when used as a combination treatment with Libtayo for solid tumors.
May 24, 2024
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2 min read
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Tristan Manalac
Drug Development
FDA Rejects Regeneron’s Blood Cancer Therapy for Two Forms of Lymphoma
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
March 25, 2024
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2 min read
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Tyler Patchen
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