NFE2L2

LifeVantage Transforms the Future of Skin Health and Radiance: Introducing the TrueScience® Activated Skin Care Collection

Retrieved on: 
Monday, March 4, 2024
Cream, Collection, Love, Protandim, Customer, NFE2L2, Caffeine, Ageing, Consultant, Skin, Health, Cosmetics

Steve Fife, President and CEO of LifeVantage, expressed his excitement about the new collection: “TrueRenew was just the beginning of a new era of activated skincare for LifeVantage.

Key Points: 
  • Steve Fife, President and CEO of LifeVantage, expressed his excitement about the new collection: “TrueRenew was just the beginning of a new era of activated skincare for LifeVantage.
  • With the TrueScience Activated Skin Care Collection, we've kept the ingredients our customers love and elevated everything else to exceed their expectations.
  • LifeVantage's TrueScience Activated Skin Care Collection directly answers these demands, featuring scientifically-backed ingredients that tackle various skin issues, all while upholding the Company’s commitment to its clean standards.
  • For more information on the Activated Skin Care Collection and to experience the future of skincare, visit the LifeVantage website ( www.lifevantage.com ).

Fortress Biotech Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Tuesday, November 14, 2023
NDA, Fortress Biotech, Food, SBMA, BLA, Exercise, Patient, Agreement, FDA, Marketing, New Drug Application, Fortification, Rosacea, Hyperhidrosis, PDUFA, Dermatology, Video game, Pharmaceutical industry, NFE2L2, Avenue, Hong Kong, Checkpoint

MIAMI, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2023.

Key Points: 
  • Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In the third quarter of 2023, Fortress and our partner companies and subsidiaries continued to advance our diverse portfolio of drug candidates.
  • Journey Medical’s total product net revenues were $15.3 million for the third quarter of 2023, compared to third quarter 2022 total product net revenues of $16.0 million.
  • Fortress’ consolidated net revenue totaled $34.8 million for the third quarter of 2023, which included $15.3 million in net product revenue generated from our marketed dermatology products.
  • Consolidated selling, general and administrative expenses were $21.7 million for the third quarter of 2023, compared to $30.1 million for the third quarter of 2022.

Human medicines European public assessment report (EPAR): Skyclarys, Omaveloxolone, Status: Opinion

Retrieved on: 
Monday, December 18, 2023
Medicine, Vomiting, Applicant (sketch), ATC, ALT, European Commission, Back pain, Ageing, International, INN, Headache, Friedreich's ataxia, Spasm, Fatigue, EMA, Civil service commission, Patient, Nuclear, Medication package insert, Ataxia, Appetite, CHMP, FA, Marketing, Oxidative stress, Committee, Medical Subject Headings, Diarrhea, Nausea, HIV disease progression rates, Instrumentation, Vaccine, Pharmaceutical industry, Medicinal plants, NFE2L2

The active substance of Skyclarys is omaveloxolone (ATC code: not yet assigned).

Key Points: 
  • The active substance of Skyclarys is omaveloxolone (ATC code: not yet assigned).
  • Omaveloxolone activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway which is involved in the cellular response to oxidative stress.
  • The full indication is:
    Skyclarys is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
  • Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Avenue Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)

Retrieved on: 
Thursday, July 27, 2023
DSM-IV codes, Spinal and bulbar muscular atrophy, Neurodegenerative disease, Clinical trial, Biomarker, Anterior grey column, SBMA, MRI, NRF1, Oxidative stress, Patient, NFE2L2, Therapy, AR, Safety, Pharmaceutical industry, Medical imaging, Avenue

MIAMI, July 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease.

Key Points: 
  • MIAMI, July 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease.
  • “We are excited to announce that the first patient has been dosed in our Phase 1b/2a clinical trial evaluating AJ201 for the treatment of SBMA, a progressive and devastating neurodegenerative disease that currently has no approved treatments available,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
  • “We are encouraged by the Phase 1 clinical data of AJ201 that demonstrate the drug’s excellent safety profile in healthy volunteers.
  • The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA.

Reata Pharmaceuticals Appoints Rajiv Patni, M.D., as Executive Vice President, Chief Research & Development Officer

Retrieved on: 
Tuesday, June 13, 2023
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, BS, Portola Pharmaceuticals, Reata Pharmaceuticals, Roche, Chief business development officer, CMO, Medication, MD, Patient, Mount Sinai School, European Medicines Agency, Knowledge, Growth, Cardiology, Albert Einstein College of Medicine, NFE2L2, Therapy, Regulation of tobacco by the U.S. Food and Drug Administration, Neurology, Food, Pfizer, Management, Pharmaceutical industry, Actelion

Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a global biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced the appointment of Rajiv Patni, M.D., as Executive Vice President, and Chief Research & Development Officer.

Key Points: 
  • Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a global biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced the appointment of Rajiv Patni, M.D., as Executive Vice President, and Chief Research & Development Officer.
  • Dr. Patni will report to Warren Huff, Chief Executive Officer, and will be responsible for overseeing the Company’s research and development functions.
  • His previous experience and his proven track record will help position the company for future growth,” said Warren Huff, Chief Executive Officer.
  • Prior to joining Reata, Dr. Patni was Chief Medical Officer (CMO) at Global Blood Therapeutics from 2020 to 2023.

Pan-Biome Pharmaceuticals, a startup focused on age-related diseases and increasing human healthspan, reports positive results in a preclinical trial of colitis

Retrieved on: 
Tuesday, April 25, 2023
Health Promotion International, Exercise, Spanish National Center for Biotechnology, TNF, Diabetes, CSO, Inflammaging, AMPK, NRF2, Colitis, Ageing, IL-6, Brain, Inflammation, Doctor of Philosophy, Oxidative stress, Metabolism, Ottawa Hospital Research Institute, Chronic condition, Mouse, Cytokine, Longevity, Notifiable disease, Rheumatoid arthritis, Conditional sentence, Pharmaceutical industry, Vaccine, NFE2L2

We have found that the compound demonstrates selective antimicrobial activity and has the ability to modulate the gut microbiome in mice.

Key Points: 
  • We have found that the compound demonstrates selective antimicrobial activity and has the ability to modulate the gut microbiome in mice.
  • Most age-related diseases are accompanied by chronic low-grade inflammation (Inflammaging), resulting in higher levels of pro-inflammatory cytokines in the bloodstream.
  • Pan-Biome’s lead compound activates anti-inflammatory cytokine IL-10 and inhibits the major pro-inflammatory cytokines TNF-a, IL-1b, and IL-6.
  • Pan-Biome CSO Dr. Poul Sorensen: “While we are still working out the mechanism, our compound most likely optimizes mitochondrial functionality.

EpicentRx Receives Fast Track Designation from the U.S. FDA for Lead Asset, RRx-001, to Prevent/Attenuate Chemotherapy and Radiation Treatment Induced Severe Oral Mucositis

Retrieved on: 
Wednesday, March 29, 2023
Radiation, Infection, New Drug Application, NDA, NLRP3, Fast Track, Mucositis, SOM, Investigational New Drug, Patient, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, News, Food, Pharmaceutical industry, NFE2L2

TORREY PINES, Calif., March 29, 2023 /PRNewswire/ -- EpicentRx, Inc. ("EpicentRx"), announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to RRx-001, a direct NLRP3 inhibitor and Nrf2 upregulator with anti-inflammatory and antioxidant properties, for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head & neck cancer patients. The FDA also accepted the company's Investigational New Drug (IND) application to initiate a follow-on phase 2b clinical trial, called KEVLARx, in the same head & neck cancer patient population.

Key Points: 
  • The FDA also accepted the company's Investigational New Drug (IND) application to initiate a follow-on phase 2b clinical trial, called KEVLARx, in the same head & neck cancer patient population.
  • In this case, the unmet medical need is severe oral mucositis (SOM), for which no treatment is currently available.
  • SOM is not only a debilitatingly painful side effect of chemotherapy and radiation, but it is also potentially life-threatening because of concomitant infections.
  • "The Fast Track Designation is great news for EpicentRx, and it puts us one step closer to a potential treatment for this critical unmet need of oral mucositis with RRx-001," said EpicentRx CEO, Dr. Tony Reid.

EpicentRx To Present at International Symposium on the Neuroprotective Effects of RRx-001 in Alzheimer's and Parkinson's diseases in Multiple Disease Models

Retrieved on: 
Tuesday, March 28, 2023
Pathology, NLRP3, International Conference on Emerging Infectious Diseases, Queensland University of Technology, Brain, Inflammation, University of Queensland, Conference, Pharmaceutical industry, NFE2L2, Alzheimer's disease

TORREY PINES, Calif., March 28, 2023 /PRNewswire/ -- EpicentRx, Inc. ("EpicentRx"), a leading-edge, clinical-stage biopharmaceutical company, has been selected for a symposium presentation at AD/PD 2023, an International Conference on Alzheimer's & Parkinson's Diseases taking place in Gothenburg, Sweden during March 28-April 1, 2023.

Key Points: 
  • TORREY PINES, Calif., March 28, 2023 /PRNewswire/ -- EpicentRx, Inc. ("EpicentRx"), a leading-edge, clinical-stage biopharmaceutical company, has been selected for a symposium presentation at AD/PD 2023, an International Conference on Alzheimer's & Parkinson's Diseases taking place in Gothenburg, Sweden during March 28-April 1, 2023.
  • The presentation by Dr. Richard Gordon, associate professor at the Queensland University of Technology and an internationally recognized expert on inflammasome signaling in neurodegenerative diseases, will focus on RRx-001, a direct NLRP3 inhibitor and Nrf2 upregulator, and its impact on the pathology of Alzheimer's and Parkinson's diseases in multiple disease models.
  • NLRP3 inflammasome activation, which triggers inflammation, and Nrf2 dysregulation, which is related to lower levels of antioxidant protection in the brain, are centrally implicated in several neurodegenerative diseases, including Alzheimer's and Parkinson's diseases.
  • Details on the company's presentation are below:

Kuria Therapeutics Completes FDA Pre-IND Consultation for Topical Nrf2 Activator for Corneal Endothelial Disease

Retrieved on: 
Friday, March 17, 2023
Science, Biotechnology, Research, Pharmaceutical, Optical, Health, FDA, Clinical Trials, Partnership, Therapy, Drug discovery, Clinical trial, Paratriathlon, Cornea, Patient, Visual acuity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, NFE2L2, IND

KTX-1161 is a topical ophthalmic solution formulation of SCO-116, a novel Nrf2 activator being developed under a license from SCOHIA PHARMA ( https://www.scohia.com/eng/ ).

Key Points: 
  • KTX-1161 is a topical ophthalmic solution formulation of SCO-116, a novel Nrf2 activator being developed under a license from SCOHIA PHARMA ( https://www.scohia.com/eng/ ).
  • Kuria is developing KTX-1161 to treat patients with diseases of the corneal endothelium, including patients with Fuchs’ endothelial corneal dystrophy and patients undergoing cataract surgery.
  • The purpose of the pre-IND consultation was to gain FDA concurrence on Kuria’s nonclinical IND-enabling plans, as well as to seek FDA guidance on the design of the Phase 2 clinical program for KTX-1161.
  • Extensive evidence supports the role of Nrf2 activation in promoting corneal endothelial function, and KTX-1161 may be applicable to multiple associated vision-threatening conditions.

Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201, a First-in-Class Clinical Asset for the Treatment of Spinal and Bulbar Muscular Atrophy

Retrieved on: 
Thursday, March 2, 2023
Safety, Walking, DSM-IV codes, Spinal and bulbar muscular atrophy, NFE2L2, Cell death, Patient, Spinocerebellar ataxia, Choking, Speech, Literature, Therapy, Anterior grey column, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Muscle atrophy, Oxidative stress, Orphan, SBMA, Food, AR, Pharmaceutical industry, Avenue

“The license for AJ201 brings a cutting-edge asset into Avenue’s pipeline that is the lead molecule in the clinic to treat Kennedy’s Disease, a debilitating rare neuromuscular disorder.

Key Points: 
  • “The license for AJ201 brings a cutting-edge asset into Avenue’s pipeline that is the lead molecule in the clinic to treat Kennedy’s Disease, a debilitating rare neuromuscular disorder.
  • SBMA is a rare, inherited, X-linked genetic neuromuscular disease primarily affecting men.
  • The weakening of the bulbar muscles affects chewing, speech and swallowing, with patients prone to choking or inhaling foods or liquids, resulting in airway infection.
  • This study aims to evaluate the safety and clinical response of AJ201 in patients suffering from SBMA.