The death of a patient caused Seattle Children's to pause its phase I study of relapsed/refractory pediatric acute myeloid leukemia (AML). It’s another hitch in the world of ground-breaking CAR T treatments that can have a serious downside.
For Jeff Galvin, the CEO and founder of newly launched Addimmune Inc., HIV is not a condition that’s in the rearview mirror. It needs a functional cure to save lives, make people healthier and save money that need not have been spent. People wonder why it’s worth bothering to cure HIV, Galvin told BioWorld, when they are taking their medications every day and they are feeling pretty close to normal. But it’s not close for Galvin, who noted that there are side effects from taking the pills that can cause headaches, fatigue, nausea and diarrhea.
Following strong phase I study data in malignant melanoma released a year ago, Ultimovacs ASA’s lead candidate, UV-1, stumbled in the phase II trial, which did not meet the primary endpoint of progression-free survival in second-line treatment of malignant pleural mesothelioma.
Since accelerated approvals first began to be granted in 1992, their pace for cancer indications has increased dramatically but a revolution in science has made it tough for the U.S. FDA to find its balance.
Despite the title of the Sunday, June 4 lead-off presentation at the American Society of Clinical Oncology (ASCO) meeting in Chicago, there was little room left for doubt about the increasingly important place of artificial intelligence (AI) in drug development.
Despite the title of the Sunday, June 4 lead-off presentation at the American Society of Clinical Oncology (ASCO) meeting in Chicago, there was little room left for doubt about the increasingly important place of artificial intelligence (AI) in drug development. The program, Artificial Intelligence for Drug Development: Fad or Future, ultimately pointed to a positive future, with the only faddish part being discarded approaches that no longer work.
Positive data from two studies treating early breast cancer with CDK4/6 inhibitors presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago showed progress is helping patients live longer. The two treatments and companies, Novartis AG and Eli Lilly and Co., are nearly head-to-head competitors in the niche indication.
Despite the title of the Sunday, June 4 lead-off presentation at the American Society of Clinical Oncology (ASCO) meeting in Chicago, there was little room left for doubt about the increasingly important place of artificial intelligence (AI) in drug development.
An unexpected burst of early summer heat and three nights of Taylor Swift performances at nearby Soldier Field didn’t deter tens of thousands of cancer vaccine and therapy developers from swarming Chicago’s McCormick Place for the first full day of presentations at the American Society of Clinical Oncology (ASCO) meeting, one of the year’s biggest cancer conferences.
Aridis Pharmaceuticals Inc. has taken a few knocks in the past year but its new agreement with the U.S. FDA is giving it an opportunity to move forward. The company’s stock (NASDAQ:ARDS) rose 115% on May 31 to close at 39 cents per share as the company and agency agreed on the design of a single confirmatory phase III superiority study of AR-301 (tosatoxumab), an adjunctive therapy for treating pneumonia caused by gram-positive bacteria Staphylococcus aureus in mechanically ventilated hospitalized patients.
