News & Updates

Repertoire® Immune Medicines Enters Research Collaboration With UMass Chan Medical School to Identify the Underlying Immune Causes of Vitiligo

02/24/2022

Research collaboration will utilize Repertoire’s DECODE™ platform to identify specific T cell receptors and antigens causing onset and progression of autoimmune disease vitiligo, with goal of developing targeted immunotherapy Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Repertoire Immune Medicines, Inc. today announced it has entered a sponsored research agreement with UMass Chan Medical School (UMass Chan)…

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U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Supplemental Biologics License Application for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma

02/23/2022

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years U.S. FDA has assigned a target action date of June 24, 2022 Excerpt from the…

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Myrtelle Announces Positive Preliminary Clinical Data for Its Proprietary Gene Therapy in Canavan Disease

02/23/2022

Myrtelle’s Phase 1/2 clinical trial introduces first-of-its-kind proprietary recombinant adeno-associated virus (rAAV) vector designed to enable targeting of oligodendrocytes To date, 3 patients received gene therapy with the rAAV vector at a dose of 3.7 x 1013 vg delivered via intracerebroventricular administration Available follow-up data in treated patients demonstrate favorable safety and tolerability with encouraging initial…

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Fluidigm Announces Collaboration Agreement with the Abu Dhabi Stem Cells Center to Accelerate Imaging Mass Cytometry in Development of Targeted Stem Cell Therapies

02/23/2022

Excerpt from the Press Release: Collaboration Enables Further Expansion of Mass Cytometry in the Middle East SOUTH SAN FRANCISCO, Calif., Feb. 17, 2022 (GLOBE NEWSWIRE) — Fluidigm Corporation (Nasdaq: FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced a collaboration agreement with the Abu Dhabi Stem Cells Center (ADSCC) for…

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Spero Therapeutics Announces Positive Topline Results from Phase 1 Bronchoalveolar Lavage Clinical Trial of SPR206, A Novel Intravenous Next Generation Polymyxin Antibiotic for the Treatment of Multi-drug Resistant Gram-Negative Infections in the Hospital Setting

02/22/2022

SPR206 shown to be well-tolerated; achieved lung exposures consistent with predicted therapeutic levels, when administered three times daily at 100 mg Results support further development of SPR206 in the setting of hospital-acquired pneumonia and ventilator-associated pneumonia Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 16, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), today announced…

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Theradaptive Wins Additional FDA Breakthrough Designation for Spinal Fusion

02/22/2022

Excerpt from the Press Release: FREDERICK, Md. and BOSTON, Feb. 15, 2022 /PRNewswire/ — Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation for its OsteoAdapt SP Spinal Fusion implant indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis,…

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Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19

02/22/2022

Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-235, a coronavirus 3CL protease inhibitor (also known as the main coronavirus…

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EyePoint Pharmaceuticals Announces Updated Positive Interim Safety and Efficacy Data from Ongoing Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet AMD

02/21/2022

– Continued positive efficacy and durability with stable visual acuity (VA) and optical coherence tomography (OCT) through eight-month follow-up – 41% of eyes remained rescue free up to nine months after a single dose of EYP-1901 – Positive safety data continued with no dose limiting toxicities, no ocular serious adverse events (SAEs) and no drug-related…

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Maze Therapeutics Presents New Preclinical Data Supporting Advancement of MZE001 as a Potential Treatment for Pompe Disease

02/21/2022

Findings Highlight Potential of Oral Substrate Reduction Therapy to Lower Disease-Causing Glycogen Build-up as a Treatment for Pompe Disease Data Support Advancement of MZE001 into Phase 1 Clinical Trial Expected to Start in First Half of 2022 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Maze Therapeutics, a company translating genetic insights into new…

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Veklury® (Remdesivir) Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants in Multiple In Vitro Studies

02/21/2022

— Data Supports the Continued Use of Veklury for Treatment of COVID-19 for Current SARS-CoV-2 Variants – Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today released data demonstrating the in vitro activity of Veklury® (remdesivir) against ten SARS-CoV-2 variants, including Omicron. Results of Gilead studies are consistent with other in vitro studies independently conducted…

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