Steroid

Aurinia Presents Data Reinforcing LUPKYNIS® Safety and Efficacy for People with Lupus Nephritis at Congress of Clinical Rheumatology East 2024

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星期四, 五月 9, 2024
Research, FDA, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Congress, Glucocorticoid, Safety, Patient, Kidney, Lupus nephritis, Proteinuria, CNI, EULAR, Rheumatology, Steroid, Cyclophosphamide, Comparison, CCR, Standard of care, MMF, Pharmaceutical industry

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced the presentation of two studies at the annual Congress of Clinical Rheumatology (CCR) East 2024 taking place in Destin, FL, May 9-12.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced the presentation of two studies at the annual Congress of Clinical Rheumatology (CCR) East 2024 taking place in Destin, FL, May 9-12.
  • The data reinforce previous findings on the safety and effectiveness of LUPKYNIS (voclosporin), a second generation calcineurin inhibitor (CNI), in combination with MMF and steroids, for the treatment of adult patients with active lupus nephritis (LN), as shown in the AURORA Clinical Program.
  • Safety and efficacy outcomes for propensity-matched patients with active LN from the AURA-LV plus AURORA 1 studies were assessed at three and six months.
  • “Early reduction in proteinuria after initial treatment has been associated with improved long-term kidney outcomes in lupus nephritis,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.

World Lupus Federation Global Survey Finds 91% of People with Lupus Report Using Oral Steroids to Treat Lupus

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星期一, 五月 6, 2024
Pain, Inflammation, Patient, Kidney, Weight gain, Risk, Skin, Blood, Heart, Diabetes, Lupus, Insomnia, Paratriathlon, Osteoporosis, Steroid, Joint, Disease, MPH, Infection, Immune system, Prednisone, Pelvic floor dysfunction, Dietary supplement

WASHINGTON, May 6, 2024 /PRNewswire/ -- A recent global survey conducted by the World Lupus Federation reported that 91% of survey respondents were taking or have taken oral steroids to treat their lupus. Over 7,700 people living with lupus from more than 100 countries participated in the survey.

Key Points: 
  • WASHINGTON, May 6, 2024 /PRNewswire/ -- A recent global survey conducted by the World Lupus Federation reported that 91% of survey respondents were taking or have taken oral steroids to treat their lupus.
  • The World Lupus Federation established World Lupus Day on May 10 to unite lupus groups around the world during Lupus Awareness Month and call attention to the disease's impact on the millions of people globally affected by lupus.
  • As we approach World Lupus Day, it is crucial that we continue to advocate for improved access to safe and effective treatments for lupus.
  • The World Lupus Federation is encouraging people around the globe on May 10 for World Lupus Day to share facts about lupus, including from this survey, and raise awareness using the official World Lupus Day Toolkit .

World Lupus Federation Global Survey Finds 91% of People with Lupus Report Using Oral Steroids to Treat Lupus

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星期一, 五月 6, 2024
Pain, Inflammation, Patient, Kidney, Weight gain, Risk, Skin, Blood, Heart, Diabetes, Lupus, Insomnia, Paratriathlon, Osteoporosis, Steroid, Joint, Disease, MPH, Infection, Immune system, Prednisone, Pelvic floor dysfunction, Dietary supplement

WASHINGTON, May 6, 2024 /PRNewswire/ -- A recent global survey conducted by the World Lupus Federation reported that 91% of survey respondents were taking or have taken oral steroids to treat their lupus. Over 7,700 people living with lupus from more than 100 countries participated in the survey.

Key Points: 
  • WASHINGTON, May 6, 2024 /PRNewswire/ -- A recent global survey conducted by the World Lupus Federation reported that 91% of survey respondents were taking or have taken oral steroids to treat their lupus.
  • The World Lupus Federation established World Lupus Day on May 10 to unite lupus groups around the world during Lupus Awareness Month and call attention to the disease's impact on the millions of people globally affected by lupus.
  • As we approach World Lupus Day, it is crucial that we continue to advocate for improved access to safe and effective treatments for lupus.
  • The World Lupus Federation is encouraging people around the globe on May 10 for World Lupus Day to share facts about lupus, including from this survey, and raise awareness using the official World Lupus Day Toolkit .

MoonLake Immunotherapeutics inks three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions 

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星期三, 四月 10, 2024
Komodo, Psoriatic arthritis, Arthropathy, Holocene, HS, Skin, Hidradenitis suppurativa, Partnership, Research, Literature, Entrepreneurship, Disease, Steroid, Patient, Inflammation, Marketing, Moonlake, Prevalence, Pharmaceutical industry

San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.

Key Points: 
  • San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.
  • Through this multiyear technology partnership, MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision making across its clinical operations, medical, marketing, and market access teams.
  • Komodo’s data and technology applications will support MoonLake’s in-depth market research, clinical trial site selection, go-to-market strategies, and patient journey mapping – all aimed at accelerating the development of new treatment options and improving outcomes for patients with inflammatory skin and joint diseases.
  • Tino Anthamatten, VP Marketing & Market Access & Pricing, MoonLake Immunotherapeutics, commented: “We need an experienced technology partner that can help accelerate our disease insights for our clinical, medical, and commercial endeavors.

MoonLake Immunotherapeutics Inks Three-Year Technology Partnership With Komodo Health To Advance Research on Inflammatory Skin and Joint Conditions

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星期三, 四月 10, 2024
Technology, Biotechnology, Health, Other Health, Pharmaceutical, Artificial Intelligence, Other Science, Other Technology, Research, Software, General Health, Health Technology, Science, Data Management, Komodo, Psoriatic arthritis, Arthropathy, Holocene, HS, Skin, Hidradenitis suppurativa, Marketing, Partnership, Literature, Entrepreneurship, Disease, Steroid, Patient, Inflammation, Multimedia, Moonlake, Prevalence, Pharmaceutical industry

MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.

Key Points: 
  • MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.
  • View the full release here: https://www.businesswire.com/news/home/20240410438883/en/
    Through this multiyear technology partnership, MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision-making across its clinical operations, medical, marketing, and market access teams.
  • Tino Anthamatten, VP, Marketing & Market Access & Pricing, MoonLake Immunotherapeutics, commented: “We need an experienced technology partner that can help accelerate our disease insights for our clinical, medical, and commercial endeavors.
  • The real-world insights from Komodo helped validate a future HS market size projected to exceed $10B by 2035.

Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1[...]

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星期二, 四月 9, 2024
Eurostat, Diagnosis, Failure, Civil service commission, Enzyme, Protease, Disease, Infection, Inflammation, Patient, Committee, Knowledge, Netherton syndrome, Regulation, EMA, IRIS, Life, Protein, Kallikrein, European, Skin, COMP, Water, Safety, European Commission, MDC, Calcineurin, Moisturizer, Steroid, Syndrome, Medicine, Pharmaceutical industry

Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} Treatment of Netherton syndrome, 17/10/2019 Positive

Key Points: 


Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} Treatment of Netherton syndrome, 17/10/2019 Positive

Muscular Dystrophy Association’s Funding of Foundational Research Leads to New FDA Approved Treatment Duvyzat (givinostat) for Duchenne Muscular Dystrophy

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星期四, 三月 21, 2024
HDAC, Gene expression, Cell, Disease, MDA, Associate, Patient, Research, DNA, Public policy, University, Muscular dystrophy, Doctor of Philosophy, Muscular Dystrophy Association, Duchenne muscular dystrophy, Clinical trial, Therapy, Histone deacetylase inhibitor, Stair climbing, Plasma protein binding, FDA, Steroid, DMD, Parent, Lancet, Pediatrics, Human, Food, Pharmaceutical industry

"The approval of Duvyzat (givinostat) provides another significant treatment option for people living with Duchenne muscular dystrophy,” said Sharon Hesterlee, PhD, Chief Research Officer, MDA.

Key Points: 
  • "The approval of Duvyzat (givinostat) provides another significant treatment option for people living with Duchenne muscular dystrophy,” said Sharon Hesterlee, PhD, Chief Research Officer, MDA.
  • “Muscular Dystrophy Association’s funding was fundamental for the discovery of HDACi in the treatment of Duchenne muscular dystrophy.
  • “We’re excited to celebrate this additional treatment option for people living with Duchenne muscular dystrophy.
  • My son is an example,” said Jessica Curran, MDA family member and mother of Conner who lives with Duchenne muscular dystrophy.

Catalyst Pharmaceuticals Announces AGAMREE® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (DMD)

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星期三, 三月 13, 2024
Catalyst Pharmaceuticals, Steroid, Caregiver, Patient, Ageing, Duchenne muscular dystrophy, Hope, Fatality, Quality of life, Respiratory failure, Behavior, Vamorolone, FDA, DMD, Muscular dystrophy, Food, Pharmaceutical industry

CORAL GABLES, Fla., March 13, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company, today announced the U.S. commercial launch of AGAMREE® (vamorolone) oral suspension 40 mg/mL for the treatment of Duchenne Muscular Dystrophy ("DMD") in patients aged two years and older. Following the U.S. Food and Drug Administration ("FDA") approval on October 26, 2023, AGAMREE is now available by prescription and dispensed throughout the United States through a specialty pharmacy network.

Key Points: 
  • "Today, we proudly announced the U.S. commercial availability of AGAMREE, an innovative alternative steroid treatment for Duchenne Muscular Dystrophy.
  • Our Catalyst Pathways, a personalized program, is readily available to assist Duchenne Muscular Dystrophy patients and their families with the one‐on‐one education and financial support they need, thereby enhancing the access and affordability of AGAMREE for every patient.
  • For more information, caregivers and healthcare professionals can call 1-833-422-8259 or visit the Catalyst Pathways® website at www.yourcatalystpathways.com .
  • Duchenne Muscular Dystrophy, DMD, the most common form of muscular dystrophy, is a rare and life-threatening neuromuscular disorder characterized by progressive muscle dysfunction, ultimately leading to loss of ambulation, respiratory failure, and fatality.

BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers

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星期一, 三月 25, 2024
Professional Services, Health, Finance, Clinical Trials, Research, Science, Pharmaceutical, PDE10, Phases of clinical research, Ulcerative colitis, Brain, IL6, Disease, Tumor necrosis factor, Central nervous system, IL8, Benevolence, Patient, CNS, CGMP, UC, Camp, Șaeș, Trial of the century, BAI, Cytokine, Drug development, Safety, Inflammatory bowel disease, Euronext Amsterdam, Steroid, JAK, Pharmaceutical industry

BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.

Key Points: 
  • BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.
  • As a result, BenevolentAI’s scientists designed BEN-8744 to be not only a potent PDE10 inhibitor, but also a peripherally-restricted molecule, i.e.
  • The Phase Ia study results support this profile, showing no evidence of CNS-associated adverse events at any dose level.
  • It is anticipated that the full results from this study will be presented in a peer-reviewed forum at a later date.

NSF Marks Milestones in Personal Care for Athletes

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星期四, 三月 21, 2024
General Sports, Sports, Natural Resources, Other Retail, Specialty, Cosmetics, Cannabis, Retail, CFL, Solvent, Health, Certification, Organization, Sport, Therapy, Dietary supplement, Risk, Senior ice hockey, National Hockey League, Public, Good manufacturing practice, LPGA, Ironman, Selective androgen receptor modulator, AFL, Growth hormone, CBD, Massage, Athlete, NHL, GMP, NSF, MLB, CCES, Diuretic, Former, USADA, Good, Sports medicine, NBA, PGA, THC, UFC, Steroid, NFL, NASCAR, Major League Baseball, Nursing

These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.

Key Points: 
  • These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.
  • "The spirit of clean athletic competition is something we all connect with,” said David Trosin, Senior Director, Global Certification at NSF.
  • NSF Certified for Sport® certifies dietary supplements, functional foods, cosmetics and personal care products to be free from substances banned by major sporting organizations.
  • Products Certified for Sport® must also be certified to either NSF/ANSI 173, NSF 229 or NSF 527 to ensure their contents match their claims.