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3,969 Results for "Regeneron".
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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
Regeneron’s Gene Therapy Shows ‘Dramatic’ Hearing Improvement in Deaf Kids
Regeneron Pharmaceuticals on Wednesday revealed that its investigational gene therapy DB-OTO restored hearing in two young children, according to an oral presentation at the American Society of Gene & Cell Therapy annual meeting.
May 8, 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
Pharm Country
Regeneron Announces Investor Conference Presentations - May 06, 2024
Regeneron Pharmaceuticals, Inc. will webcast management participation as follows.
May 6, 2024
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1 min read
Drug Development
Sanofi, Regeneron Post Strong Phase III COPD Data for Dupixent as FDA Decision Looms
Late-stage results from the NOTUS trial showed Sanofi and Regeneron’s Dupixent lowered moderate to severe chronic obstructive pulmonary disease exacerbations by 34% and led to significantly better lung function.
May 21, 2024
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2 min read
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Tristan Manalac
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