Enforcement Report - Week of January 31, 2024
Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial Due To The Potential For Presence of Glass Particulate Matter
The shuttering of Teva’s long troubled manufacturing facility in Irvine, California, may create shortages of up to 24 generic sterile injectable drugs, including five essential medications of which the company supplied more than 15% of the market last year, according to an industry group.
BOTHELL, Wash.--(BUSINESS WIRE)--Seagen Inc. (Nasdaq:SGEN) today announced that the phase 3 ECHELON-1 clinical trial demonstrated a statistically significant improvement in overall survival (OS) (p=0.009) in patients with advanced classical Hodgkin lymphoma (cHL) following treatment with ADCETRIS (brentuximab vedotin) in combination with chemotherapy. With approximately six years median follow up, patients receiving ADCETRIS plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in the frontline setting had a 41 percent reduction in the risk of death (HR 0.59; [95% CI: 0.396 to 0.879]) compared with patients receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The safety profile of ADCETRIS was consistent with previous studies and no new safety signals were observed.
Enforcement Report - Week of September 1, 2021
Cipla`s Generic Bleomycin Sulfate Receives Approval in US
JIANGSU YEW Pharmaceutical Co. Ltd. Fails EDQM Inspection
Seattle Genetics has announced that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018.
Seattle Genetics $SGEN CEO Clay Siegall ran into a wall of skepticism last summer when he rolled out positive data from their Phase III study of a new cocktail for frontline Hodgkin lymphoma. Dropping the toxic bleomycin from the standard chemo combo used to treat the disease, researchers for the biotech — partnered with Takeda — had come up with a lean but significant 5-point PFS advantage for the company’s flagship therapy.
Five drugs suspended after factory inspection