Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. received U.S. Food and Drug Administration (FDA) approval for Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Genentech’s Herceptin (trastuzumab) for the following indications: Adjuvant Breast Cancer of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin,…
Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results
Teva Pharmaceutical and Regeneron Pharmaceuticals announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary efficacy analysis, the study met both co-primary endpoints and all key secondary endpoints. Fasinumab-treated patients experienced significantly less…
Updated Indication For Teva’s Granix Injection Approved In U.S.
Teva Pharmaceutical announced today that the U.S. FDA has approved Granix (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients one month and older. Granix is indicated to reduce the duration of severe neutropenia in adult and pediatric patients one month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence…
Teva To Discontinue Chronic Cluster Headache Trial
Teva Pharmaceutical announced a change in the clinical development program of fremanezumab in chronic cluster headache. The ENFORCE Phase III clinical development program includes a chronic cluster headache study, an episodic cluster headache study, and a long-term safety study. A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint of mean…
Teva Launches Generic Version Of Lialda In The U.S.
Mesalamine delayed-release tablets are indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. “The launch of mesalamine is a significant addition to Teva’s generic portfolio,” said Brendan O’Grady, Executive Vice President and head of North America Commercial at Teva. “With…
Teva’s Trisenox Injection Okayed For First Line Leukemia Treatment
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the use of Trisenox (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based…
Teva Announces Exclusive Launch Of Generic Viread In US
Teva Pharmaceutical Industries Ltd., announced the exclusive launch of generic Viread1 (tenofovir disoproxil fumarate) tablets 300 mg in the U.S. Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. Additionally,…