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CYAD-211 / Celyad OncologyCelyad Oncology Announces FDA Clearance of IND Application for CYAD-211, First shRNA-based, Non-Gene Edited Allogeneic CAR T Therapy (GlobeNewswire) - Jul 14, 2020 - "Celyad Oncology...announced that the company’s Investigational New Drug (IND) application for CYAD-211, the company’s first-in-class short hairpin RNA (shRNA)-based allogeneic CAR T candidate and second non-gene edited off-the-shelf program, is in effect with the U.S. Food and Drug Administration (FDA)...CYAD-211 targets B-cell maturation antigen (BCMA) for the treatment of relapsed / refractory multiple myeloma (r/r MM)....We are excited to have the CYAD-211 IND in effect to initiate the Phase 1 trial by year-end 2020 for this first-in-class CAR T candidate for patients with multiple myeloma and look forward to accelerating the development of additional shRNA-based allogeneic candidates from our CYAD-200 series towards clinical trials."Enspryng (satralizumab) / RocheENSPRYNG (Satralizumab) approved by Roche in Switzerland for the treatment of Neuromyelitis Optica Spectrum Diseases (NMOSD) [Google translation] (GlobeNewswire) - Jul 14, 2020 - "Roche...announced today that Swissmedic (Swiss Agency for Therapeutic Products) has received approval for ENSPRYNG® (satralizumab) as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adults and adolescents who are AQP4-IgG seropositive....The approval by Swissmedic represents a significant scientific advance in the treatment of NMOSD and is based on the extensive results from two randomized, double-blind, placebo-controlled phase III studies."Tremfya (guselkumab) / J&JTREMFYA (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis (PRNewswire) - Jul 14, 2020 - "The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for adult patients with active psoriatic arthritis (PsA)...TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. The safety and efficacy of TREMFYA in PsA have been demonstrated in two pivotal Phase 3 clinical trials."mosunetuzumab (BTCT4465A) / RocheFDA grants Breakthrough Therapy Designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma (Roche Press Release) - Jul 14, 2020 - "Roche…announced that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies….This designation was granted based on encouraging efficacy results observed in the phase I/Ib GO29781 study [NCT02500407] investigating mosunetuzumab in R/R non-Hodgkin lymphoma (NHL)."PXS‐5505 / PharmaxisFDA GRANTS ORPHAN DRUG STATUS FOR PHARMAXIS ANTI FIBROTIC DRUG FOR MYELOFIBROSIS (Pharmaxis Press Release) - Jul 14, 2020 - "...Pharmaxis... today announced that the U.S. Food & Drug Administration (FDA) has granted orphan-drug designation for its oral pan LOX inhibitor PXS-5505 for the treatment of myelofibrosis...PXS-5505 has shown to be well tolerated in Phase 1 single and multiple ascending dose studies in humans with an excellent pharmacokinetic and pharmacodynamic profile...We expect to file an investigational new drug (IND) application with the FDA shortly and will provide an update on the clinical trial plans at that time."
