A new deal with Takeda Pharmaceutical Co. Ltd. will help Resolve Therapeutics LLC, of Seattle, forge ahead through clinical proof of concept with its investigational systemic lupus erythematosus therapy, RSLV-132. Read More
Eschewing the landscape of failures in central nervous system disorders, privately held EnVivo Pharmaceuticals Inc. showed moxie by initiating a Phase III program for lead compound EVP-6124, an alpha-7 agonist, in the lead indication of schizophrenia. Read More
Depomed Inc.'s Serada could become the first approved nonhormonal therapy for menopausal hot flashes, but its advisory committee debut Monday doesn't look like it's going to be a walk in the park. Read More
• Dezima Pharma BV, of Naarden, the Netherlands, said it raised €14.2 million (US$18.6 million) for the clinical development of its cholesteryl ester transfer protein (CETP) inhibitor, DEZ-001 (previously TA-8995), and to develop additional earlier-stage dyslipidemia assets. Read More
• Novan Therapeutics Inc., of Durham, N.C., said in vitro and animal data indicated the firm's SB204, its drug candidate for acne, could lead to a topical treatment to reduce oil production in the skin. Read More
• Prima BioMed Ltd., of Sydney, Australia, said it started recruiting patients in its CANVAS (CANcer VAccine Study) Phase II/III trial in Europe to test CVac for the maintenance treatment of newly diagnosed, late-stage epithelial ovarian cancer in patients who achieve remission after optimal debulking surgery and standard first-line chemotherapy. Read More
• CSL Behring, of King of Prussia, Pa., said the FDA approved an expansion of the indication for Corifact (Factor XIII concentrate [human]) to include the perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, enrolled the first patient in its Phase III study (POLO-AML-2) investigating volasertib, a selective polo-like kinase inhibitor, in combination with chemotherapy in patients with acute myeloid leukemia (AML) who are ineligible for intensive therapy. Read More
• Transcept Pharmaceuticals Inc., of Point Richmond, Calif., reported a net loss of approximately $12 million for the 12 months ending Dec. 31, including a fourth-quarter net loss of approximately $6.6 million, compared to a net loss of approximately $3.9 million and net income of approximately $5.3 million, respectively, in the same periods the previous year. Read More
