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.
Pfizer Inc. has positive phase III data for its hemophilia treatment as it wades deeper into an indication that already has plenty of competition and at least one company with earnings of more than $1 billion. Pfizer’s marstacimab in treating hemophilia could lead to the first once-weekly subcutaneous treatment for hemophilia B and could end up being the first treatment administered as a flat dose for treating hemophilia A or B.
Mixed phase III study results have Bioxcel Therapeutics Inc. moving ahead to complete the clinical trial while withstanding a hammering from investors. BXCL-501 (dexmedetomidine), a sublingual film being developed to treat bipolar disorders- or schizophrenia-associated agitation, produced clinically meaningful efficacy results in part 1 of the pivotal study with half of the approved dose, but the primary efficacy endpoint was not statistically significant at two hours (p=0.077). BXCL-501 separated from placebo at four hours (p=0.049).
A week ahead of its May 29 PDUFA date, the U.S. FDA has approved Xacduro (sulbactam for injection; durlobactam for injection) for treating one of the toughest and most deadly infections, carbapenem-resistant Acinetobacter baumannii, in adults.
