FDA

Biofrontera to Launch Phase 3 Clinical Study Evaluating Ameluz®-PDT for the Treatment of Actinic Keratosis on the Extremities, Neck and Trunk

12/02/2022

Excerpt from the Press Release: WOBURN, Mass., Nov. 21, 2022 (GLOBE NEWSWIRE) — Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the launch of a randomized, double-blind, vehicle-controlled, multicenter Phase 3 clinical study to evaluate the safety and efficacy of Ameluz® and BF-RhodoLED® XL in the field-directed…

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U.S. Food and Drug Administration approves CSL’s HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

12/01/2022

KING OF PRUSSIA, PA, USA This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion. Excerpt from the Press Release: This historic approval provides a new treatment option…

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Praxis Precision Medicines to Advance PRAX-562 Phase 2 Study in Pediatric Patients with Developmental and Epileptic Encephalopathies

11/30/2022

Excerpt from the Press Release: BOSTON, Nov. 28, 2022 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced plans to initiate the PRAX-562 Phase 2 EMBOLD study for the treatment of…

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Varian Announces First Participant Treated in GENESIS II Clinical Trial of Genicular Artery Embolization for Knee Osteoarthritis

11/21/2022

Excerpt from the Press Release: PALO ALTO, Calif., Nov. 17, 2022 /PRNewswire/ — Varian, a Siemens Healthineers company, announced today that the first trial participant has been treated as part of GENESIS II (Genicular artEry embolisatioN in patiEnts with oSteoarthrItiS of the knee), a study of Embozene® microspheres for genicular artery embolization (GAE) as treatment of…

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ONWARD’s Research Partner .NeuroRestore Publishes Groundbreaking Paper Identifying Neurons that Restore Walking after Paralysis

11/18/2022

Data from all nine participants in STIMO trial published in Nature Researchers identify specific neurons activated and remodeled by spinal cord stimulation that enable patients to walk Excerpt from the Press Release: EINDHOVEN, the Netherlands & LAUSANNE, Switzerland & BOSTON–(BUSINESS WIRE)–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement,…

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Merrimack Provides Ipsen Report That Onivyde® Regimen Demonstrated Statistically Significant Improvement in Overall Survival in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

11/17/2022

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] announced that Ipsen, SA (“Ipsen”) issued a press release today reporting its primary analysis of the results of its Phase III NAPOLI 3 trial of Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a treatment…

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Corner Therapeutics Debuts with Data Presentation on its Dendritic Cell Hyperactivation Platform at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/17/2022

Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Corner Therapeutics, a biotechnology company exploiting a new scientific paradigm to boost memory T cell responses to disease, debuts today with presentation of data on its dendritic cell hyperactivation (hDC) platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 8-12,…

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Aulos Bioscience Presents Initial Data From First-in-Human Phase 1/2 Clinical Trial of Computationally Designed Antibody AU-007 at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/15/2022

Data show trend in decreasing Tregs, presenting unique profile among current IL-2 therapeutics Adding Phase 1/2 clinical trial sites in the U.S. following recent IND application clearance Excerpt from the Press Release: LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today presented early…

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Neurocrine Biosciences Presents Additional Phase 3 Data for KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease at HSG 2022

11/11/2022

Excerpt from the Press Release: SAN DIEGO, Nov. 3, 2022 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a leading neuroscience-focused biopharmaceutical company, today reported additional results from the Phase 3 KINECT-HD study investigating valbenazine for the treatment of chorea associated with Huntington Disease (HD). In December 2021, Neurocrine previously reported that once-daily administration of valbenazine was well tolerated…

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Sight Sciences Announces Publication of Clinical Data Demonstrating Standalone Effectiveness of the OMNI® Surgical System in Pseudophakic Glaucoma Patients with Uncontrolled Pressure Following a Previous Combination Cataract Stent Procedure

11/11/2022

Multicenter Clinical Data from Five US sites Published in International Ophthalmology Excerpt from the Press Release: Worldwide, more than one million trabecular microbypass stents have been implanted in combination with cataract surgery. Despite glaucoma medications and prior microbypass stenting, target IOP may no longer be achieved over time. During 3 to 42 months follow-up, the…

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