Abbvie Inc. trumped Allergan plc in the effort to treat women with abnormal bleeding due to uterine fibroids. Abbvie, of North Chicago, reported top-line data from the phase III ELARIS UF-EXTEND extension study, which showed that, at 12 months, elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg/norethindrone acetate 0.5 mg), reduced heavy menstrual bleeding, with 87.9 percent of women with uterine fibroids achieving clinical response. Read More
DUBLIN – Argenx SE passed a critical milestone in its immuno-oncology alliance with Abbvie Inc., by delivering an IND package for ARGX-115, its first-in-class antibody directed at glycoprotein A repetitions predominant (GARP), a cell-surface docking receptor that modulates the activity of the immunosuppressive cytokine transforming growth factor beta (TGF-beta). Abbvie, of North Chicago, has now exercised an option on the program, in which it originally obtained an interest two and a half years ago. (See BioWorld Today, April 22, 2016.) Read More
Psilocybin, the psychoactive core of magic mushrooms, could be headed toward late-stage trials in treatment-resistant depression (TRD), pending the results of a soon-to-start phase IIb study. London-based Compass Pathways Ltd. has received permission from the FDA and additional regulators to run a dose-ranging study in up to 216 patients across Europe and North America. The trial, which seeks to enroll 216 patients at 12 to 15 research sites, will begin in the U.K. later this month and is expected to read out toward the end of 2019. Read More
Given the potential diversity of CAR T therapies and the ongoing evolution of patient-reported outcome (PRO) tools, Medicare should not require the use of PROs in making coverage determinations for new gene therapies, several experts told the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Wednesday. Read More
Ahead of June's American Society of Clinical Oncology (ASCO) meeting in Chicago, an abstract related to the data to be unveiled by Jounce Therapeutics Inc. so alarmed Wall Street that the company's shares lost 35 percent of their value, and the situation worsened when the data rolled out. But there may be cause to maintain hope for JTX-2011, the agonist of inducible T-cell co-stimulator (ICOS), a protein on the surface of certain T cells that Jounce believes can stimulate an immune response against solid tumors. Read More
Hikma Pharmaceuticals USA Inc., of Eatontown, N.J., a subsidiary of London-based Hikma Pharmaceuticals plc, appointed Kristy Ronco executive vice president, sales and marketing for its generics division. Read More
Neuren Pharmaceuticals Ltd., of Melbourne, Australia, received the initial payment of $10 million from Acadia Pharmaceuticals Inc., of San Diego, as part of their licensing agreement for Neuren's Rett syndrome and Fragile X syndrome treatment, trofinetide. (See BioWorld, Aug. 8, 2018.) Read More
Ampliphi Biosciences Corp., of San Diego, has filed to raise up to $12 million from the sale of shares of its common stock. It also intends to grant the underwriters a 30-day option to purchase additional shares. The offering has not yet been priced. The company is focused on the the development of targeted bacteriophage therapeutics for patients with serious and life-threatening antibiotic-resistant bacterial infections. Read More
