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aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRxRelief partner NeuroRx submits request for Emergency Use Authorization for RLF-100 (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy (PharmiWeb) - Sep 23, 2020 - P=NA, N=51; SAMICARE (NCT04453839); Sponsor: NeuroRx, Inc.; "...NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments....The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement."Ilumya (tildrakizumab-asmn) / Sun Pharma, AlmirallSun Pharma announces the launch of ILUMYA (tildrakizumab) for treatment of Plaque Psoriasis in Japan (Equitybulls) - Sep 23, 2020 - "Sun Pharmaceutical...today announced that its wholly-owned Japanese subsidiary has launched ILUMYA® Subcutaneous Injection 100 mg Syringe (Nonproprietary name: tildrakizumab (genetical recombination), 'ILUMYA') in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies." Xalkori (crizotinib) / PfizerFDA Accepts Supplemental New Drug Application for Pfizer’s XALKORI (crizotinib) for the Treatment of Pediatric ALK-positive Anaplastic Large Cell Lymphoma (Businesswire) - Sep 23, 2020 - “Pfizer Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application(sNDA)for XALKORI® (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive…The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2020…The FDA submission is supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588)….This FDA submission is in addition to the European Medicines Agency’s agreement on a Pediatric Investigational Plan (PIP) for XALKORI including the treatment of pediatric patients with relapsed or refractory systemic ALK-positive ALCL.”Zynteglo (betibeglogene autotemcel) / bluebird biobluebird bio’s LentiGlobin for Sickle Cell Disease Gene Therapy (bb1111) Granted Priority Medicines (PRIME) Designation by European Medicines Agency (Businesswire) - Sep 23, 2020 - "bluebird bio, Inc....announced today that its investigational treatment for sickle cell disease (SCD), LentiGlobin™ for SCD gene therapy (bb1111), was granted eligibility to the Priority Medicines (PRIME) program by the European Medicines Agency (EMA)....Clinical data from the completed Phase 1/2 HGB-205 study, the ongoing Phase 1/2 HGB-206 study and ongoing long-term safety and efficacy follow-up study LTF-303 supported the PRIME application for LentiGlobin for SCD." Epidiolex (cannabidiol) / GW PharmaGW Pharmaceuticals receives Australian Therapeutic Goods Administration (TGA) approval for EPIDYOLEX (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy (GlobeNewswire) - Sep 23, 2020 - "GW Pharmaceuticals plc...today announces that the Australian Therapeutic Goods Administration (TGA) has approved EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older....The approval of GW’s cannabidiol is based on results from four randomised, controlled Phase 3 trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers."
