The U.S. Supreme Court on June 1 declined to hear Johnson & Johnson’s bid to overturn a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in the company’s baby powder and other talc products.
Less than a month after submitting an Investigational New Drug (IND) application, Anixa Biosciences ran into a snag with the U.S. Food and Drug Administration as the government agency asked for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).
As the 2021 virtual J.P. Morgan Healthcare Conference wrapped up, BioSpace reviewed news from companies regarding their deals, pipeline and regulatory updates.
Missouri’s highest court refused to consider Johnson & Johnson’s appeal of a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in its baby powder and other talc products.
The European Medicines Agency (EMA) recommended approval for Lynparza in patients with a form of prostate cancer and as a first-line maintenance treatment for a form of advanced ovarian cancer, the British drugmaker AstraZeneca said.
AstraZeneca and Merck announced positive five-year follow-up data from the Phase III SOLO-1 trial which demonstrated a long-term progression-free survival benefit of Lynparza as a first-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated ovarian cancer who were in complete or partial response to platinum-based chemotherapy.
Roche company Genentech announced that the Phase III IMagyn050 trial of Tecentriq (atezolizumab) and Avastin (bevacizumab), paclitaxel and carboplatin did not hit the primary endpoint of progression-free survival for frontline newly diagnosed advanced ovarian cancer.
The U.S. Food and Drug Administration approved AstraZeneca and Merck’s Lynparza (olaparib) in combination with Roche’s Avastin (bevacizumab) for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer has been tested to have either a deleterious or suspected deleterious BRCA mutation and/or genomic instability.
The U.S. Food and Drug Administration cleared expanded use of GlaxoSmithKline Plc’s Zejula as a first option to keep advanced ovarian cancer at bay in women who have responded to chemotherapy.
“Put the patient first.” It’s every pharma marketer’s favorite buzz-phrase in 2020. And why not? Patients are our real customers; they use and (hopefully) benefit from our products, and their wants and needs drive the success or failure of everything we do.