Remove Antibody Remove FDA Approval Remove Immune Response Remove Sales
article thumbnail

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

article thumbnail

Ixchiq Wins FDA Approval as World’s First Chikungunya Vaccine

XTalks

Valneva recently reported that it has been experiencing an increase in sales of its other vaccines due to the “recovery of the travel industry.” It appears the company has already done so as its quarterly earnings report included $96 million and $117 million of additional revenue from the sale of the PRV in its 2023 revenue guidance.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

AstraZeneca’s Immunotherapy Imjudo (tremelimumab) Wins FDA Approval for Liver Cancer

XTalks

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death. billion in 2020, an increase of 20 percent.

article thumbnail

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.

Drugs 52
article thumbnail

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

article thumbnail

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

Drugs 59
article thumbnail

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.