Discover
llllllllll Lu AF11167 / LundbeckLundbeck discontinues phase II proof of concept study of Lu AF11167 in patients with negative symptoms of schizophrenia (Lundbeck Press Release) - Aug 5, 2020 - "H. Lundbeck A/S (Lundbeck) announces the decision to discontinue the phase II proof of concept clinical study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The decision to stop the trial is based on the results of a futility interim analysis, which concluded that the trial is unlikely to achieve statistical significance on its primary endpoint, mean change from baseline to week 12 on the Brief Negative Symptom Scale (BNSS). The recommendation to stop the trial is not based on safety concerns."llllllllll IONIS-ENAC-2.5Rx / IonisIonis reports second quarter 2020 financial results and recent business achievements (Ionis Pharmaceuticals Press Release) - Aug 5, 2020 - "Initiate a Phase 2 study of IONIS-ENaC-2.5Rx in patients with chronic obstructive pulmonary disease (COPD)"llllllllll fasinumab (REGN475) / Teva, Mitsubishi Tanabe, RegeneronREGENERON REPORTS SECOND QUARTER 2020 FINANCIAL AND OPERATING RESULTS (Regeneron Pharmaceuticals Press Release) - Aug 5, 2020 - P3, N=3,307, FACT OA1 (NCT03161093); P3, N=1,650; FACT OA2 (NCT03304379); Sponsor: Regeneron Pharmaceuticals; "Fasinumab, an antibody to NGF: Two Phase 3 trials, FACT OA1 and FACT OA2, achieved the co-primary endpoints for fasinumab 1 mg monthly, demonstrating significant improvements in pain and physical function over placebo at week 16 and week 24, respectively....Additional longer-term safety data from the ongoing trials are being collected and are expected to be reported early next year."llllllllll reboxetine (AXS-12) / Axsome TherapAxsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-12 for the Treatment of Narcolepsy (GlobeNewswire) - Aug 5, 2020 - "Axsome Therapeutics, Inc....today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in patients with narcolepsy....The Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in narcolepsy was supported by the positive results from the Phase 2 CONCERT study...'We look forward to meeting with the FDA as soon as possible to discuss the continued development of AXS-12 in light of this significant milestone.'"llllllllll Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients (GlobeNewswire) - Aug 5, 2020 - "FDA granted de novo class II for cobas EBV test following the agency’s Breakthrough Device designation...Roche...today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States....'Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients'..."
