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477 articles with Immunomedics, Inc.
Gilead has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
The SEC announced charges against Usama Malik and his former live-in girlfriend Lauren S. Wood regarding an FDA decision during a trading black out.
Immunomedics Announces FDA Orphan Drug Designation of Trodelvy™ for Adult and Pediatric Glioblastoma
Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Trodelvy (sacituzumab govitecan-hziy) orphan status for the treatment of adult and pediatric patients with glioblastoma. “Glioblastoma is an aggressive cancer with a la
9/28/2020The European Society of Medical Oncology (ESMO) Virtual Congress 2020 was last weekend and the beginning of the week, which resulted in numerous clinical trial announcements. Here’s a look.
The European Society for Medical Oncology (ESMO) Virtual Congress 2020 was this weekend, with numerous companies presenting clinical trial data and updates.
Trodelvy™ Significantly Extends Survival in Phase 3 ASCENT Study of Metastatic Triple-Negative Breast Cancer
Trodelvy significantly reduced the risk of death by 52 percent, with a median overall survival(OS) of 12.1 months compared to6.7 months for standard single-agent chemotherapy
Immunomedics Announces Positive Results from Pivotal Phase 2 TROPHY U-01 Study of Trodelvy™ in Metastatic Urothelial Cancer
Trodelvy achieves a 27 percent overall response rate and a 5.9-month median duration of response in heavily-pretreated patients with metastatic urothelial cancer (mUC)
The deal, announced Sunday, has been unanimously approved by the boards of directors of both companies.
Gilead Adds TrodelvyTM, First-in-Class Antibody-Drug Conjugate Approved to Treat Triple-Negative Breast Cancer, With Promise in Other Forms of Breast Cancer and Additional Solid Tumors
Breadth of presentations include i) Full results from ASCENT; ii) Final results from TROPHY U-01 cohort 1; iii) First results with Trodelvy™ in brain tumors
Immunomedics, Inc., a leading biopharmaceutical company in the area of antibody-drug conjugates, announced that Dr. Behzad Aghazadeh, Executive Chairman, is scheduled to participate in virtual fireside chats at the following healthcare conferences
Immunomedics Announces FDA Approval of Samsung Biologics as Antibody Manufacturer for Trodelvy™Approval enhances long-term supply of Trodelvy
Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for Samsung Biologics to produce commercial-scale hRS7, the antibody used in Trodelvy (sacituzumab govitecan-hziy), at its manufacturing facilities in Incheon, South Korea.
8/10/2020It was a moderately busy week for clinical trial news, with some particularly interesting announcements related COVID-19 vaccine trials. Here’s a look.
Confirmatory Phase 3 ASCENT study met primary endpoint of progression-free survival and key secondary endpoints of overall survival and objective response rate
Immunomedics to Report Second Quarter 2020 Results and Host Conference Call and Webcast on August 5, 2020
Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that it will host a conference call on Wednesday, August 5, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the second quarter of 2020 and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Con
Immunomedics Expands Collaboration with Roche Evaluating Trodelvy™ (sacituzumab govitecan-hziy) in Combination with Tecentriq® (atezolizumab) into Urothelial and Non-Small Cell Lung Cancers
Immunomedics, Inc.(NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced an extension of its current clinical collaboration with Roche to evaluate Trodelvy, Immunomedics’ anti-Trop-2 ADC, in combination with Tecentriq,
Immunomedics announced today that its Phase III study involving Trodelvy met its primary endpoint of progress-free survival, as well as secondary endpoints, in patients with metastatic triple-negative breast cancer who have previously received at least two prior therapies.
Immunomedics Announces Positive Results from Phase 3 ASCENT Study of TRODELVY™ in Previously-Treated Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)
Trodelvy significantly improved progression-free survival (PFS) and overall survival (OS) in previously-treated brain metastasis negative patients with advanced mTNBC The safety profile of Trodelvy was consistent with the FDA-approved label and no new safety signals were observed Trodelvy is the first antibody-drug conjugate (ADC) shown to improve clinical outcomes in people with relapsed or refractory mTNBC who have received two prior therapies sBLA submission seeking full approval
Immunomedics, Inc.(NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the Company will host a conference call and live audio webcast on Monday, July 6, 2020 at 8:00 a.m. Eastern Time to provide a clinical update.
Although the U.S. FDA is very busy dealing with emergency use approvals for diagnostics and possible treatments for COVID-19, it is still evaluating and approving therapies for non-COVID-19 indications. Here’s a look at this week’s calendar.