BioSpace News Archive

OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE ® as a treatment for patients with mild-to-moderate COVID-19. The trial, entitled “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of R AYALDEE (calcifediol) E xtended-relea s e C aps u l e s to Treat Symptomatic Patients Infected with SA

FDA Accepts Shionogi’s Supplemental New Drug Application with Priority Review for FETROJA ® (cefiderocol) for the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia OSAKA, Japan & FLORHAM PARK, N.J.--( BUSINESS WIRE )-- Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA ® (

Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that Ankit Mahadevia, M.D., President and Chief Executive Officer of Spero Therapeutics, will provide a corporate update at the Jefferies 2020 Virtual Healthcare Conference

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that Liz Barrett, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020, at 3:30 PM Eastern Time. A live audio webcast of the event will be available on the Inve

Proteona today announced that Twist Bioscience Corporation (Nasdaq: TWST) will join the international alliance led by Proteona to develop neutralizing antibody therapy against COVID-19 for vulnerable immunocompromised patients. Utilizing the highly parallel silicon-based DNA synthesis platform, Twist has the ability to manufacture millions of oligos of different lengths with industry leading accuracy. This c

Agilent Technologies Inc. (NYSE: A) today announced two new mass spectrometry (MS) products: the Agilent 6470B Triple Quadrupole LC/MS (6470 LC/TQ) system, and the Agilent RapidFire 400 system. Both deliver even faster detection of target compounds providing customers increased sample throughput and reduc

SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced today that it has re-financed its existing credit facility. Proceeds from the new $40 million, five-year term loan will be used to repay SI-BONE’s prior $40 million term loan obligation in its entirety. SI-BONE’s new term loan bears interest at a rate per annum equal to 9.40%

Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SU lopenem for R esistant E nterobacteriaceae (SURE) 2 clinical trial in complicated

Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX:RVX) is pleased to announce that it is moving forward with a plan to further evaluate apabetalone’s impact on COVID-19 in both a preclinical and clinical setting. A first step will be to investigate whether apabetalone treatment of human cells susceptible to 2019 novel coronavirus (2019-nCoV) infection will impact the replication cycle of the virus. Initial work – undertaken in an ap

ANI Pharmaceuticals, Inc. (“ANI”) (NASDAQ: ANIP) announced today that it continues to make progress toward addressing items identified in the Refusal to File letter received from the FDA relating to its Cortrophin® Gel sNDA filing. “The most efficient path forward is to concentrate efforts on the preparation of the resubmission