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Talvey Becomes J&J’s Second Multiple Myeloma Bispecific to Score FDA Approval

XTalks

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8

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Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

XTalks

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

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Sandoz’s Jubbonti and Wyost Approved as First Interchangeable Biosimilars to Amgen’s Bone Drugs Prolia and Xgeva

XTalks

The company also complained that the FDA would make an approval decision on the biosimilar before patent expirations. According to Amgen’s last earnings report , Prolia sales increased 12 percent last year to more than $4 billion, and Xgeva’s jumped five percent from last year to $2.1

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Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

XTalks

At its peak sales, Qalsody is expected to generate around $300 million for Biogen. New and Promising Treatments for ALS Amylyx Pharmaceuticals, a biopharmaceutical company based in Cambridge, Massachusetts, obtained FDA approval in 2022 for its oral medication Relyvrio (sodium phenylbutyrate and taurursodiol) for the treatment of ALS.

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.