TECENTRIQ HYBREZA

FDA Approves Tecentriq Hybreza Anti-PD-(L)1 Cancer Immunotherapy

Genentech announced the U.S. Food and Drug Administration (FDA) approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs). The first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States.

  • Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab).
  • It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin, and soft tissue cancer.
    Source: Genentech

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Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) forInjection 100mg/vial Due to the Presence of a Glass Particle

Gilead Sciences, Inc. announced it is issuing a voluntary recall of one lot of Veklury (remdesivir) for Injection 100mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company’s investigation.

Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material. The glass particulate can potentially travel, through the blood vessels, to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead has not received any reports of adverse events related to this recall.

Consumers and healthcare providers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474 Monday to Friday 5am – 6pm PST or through their website at www.askgileadmedical.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: Gilead Sciences, Inc.

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BORUZU

FDA Approves Boruzu Ready-to-Use Injection for Multiple Myeloma and Mantle Cell Lymphoma

Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. Food and Drug Administration (FDA) approval of Boruzu, a new presentation of bortezomib for ready-to-use subcutaneous or intravenous (IV) administration. This new oncology product reduces the compounding preparation steps typically required with administration. This product references the branded product Velcade , a lyophilized powder requiring reconstitution before use.

  • Boruzu (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma.
  • Shilpa developed the molecule and Amneal will manufacture and commercialize the product. Boruzu is expected to launch with a unique J-code in the second quarter of 2025.
    Source: Amneal Pharmaceuticals, Inc.

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