Steroid

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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화요일, 4월 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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목요일, 3월 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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수요일, 3월 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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월요일, 3월 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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목요일, 3월 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.

Enveric Biosciences Signs Non-Binding Term Sheets to Pursue the Exclusive Out-Licensing of New Chemical Entities for Pharmaceutical and Non-Pharmaceutical Applications in Joint Disease

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화요일, 3월 19, 2024
Biotechnology, Pharmaceutical, Other Manufacturing, Health, Mental Health, Chemicals, Plastics, Manufacturing, Other Health, Depression, Cannabinoid, Rheumatoid arthritis, Patient, Anxiety, IND, Addiction, Pathology, Therapy, Osteoarthritis, Arthropathy, Steroid, Pharmaceutical industry

The compounds are new chemical entities that include cannabinoids in conjugate form with COX-2 inhibitors and cannabinoids in conjugate form with selected steroids.

Key Points: 
  • The compounds are new chemical entities that include cannabinoids in conjugate form with COX-2 inhibitors and cannabinoids in conjugate form with selected steroids.
  • Royalty rates could range from 2.5% up to 10% on future sales, depending on meeting certain sales criteria.
  • Together, through the out-licensing of the two assets and meeting various development and sales milestones, Enveric could potentially receive milestone payments that total up to approximately $82 million.
  • “We look forward to working with our partner, and we are confident in their leadership and capabilities to continue the development of these compounds for both pharmaceutical and non-pharmaceutical applications to advance joint disease treatment options for patients.

Shaperon Enrolls Its First Patient in Phase 2 U.S. Clinical Trial for Atopic Dermatitis Therapy 'Nugel'

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월요일, 3월 18, 2024
Health, Health Technology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Growth, Atopic dermatitis, Inflammation, Patient, EASI, Technology transfer, PDE4, IND, Patent, FDA, Steroid, JAK, Pharmaceutical industry

Shaperon, Inc. (Kosdaq: 378800), a biotechnology company developing innovative immune drugs, announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis.

Key Points: 
  • Shaperon, Inc. (Kosdaq: 378800), a biotechnology company developing innovative immune drugs, announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis.
  • Employing a rigorous double-blind, placebo-controlled methodology, the trial is anticipated to conclude by the first half of 2026.
  • Market research forecasts indicate a robust growth of over 8.7%, projecting the global atopic dermatitis market to reach $19.1 billion by 2030.
  • Nugel represents a paradigm shift in atopic dermatitis therapy as the world's first inflammation control drug targeting 'GPCR19' action.

CBD Healthcare Company Becomes the First-Ever Worldwide to Earn Prestigious NSF International Certifications in Personal Care for Athletes (NSF Guideline 527 and NSF Certified for Sport)

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금요일, 3월 15, 2024
Sports, General Sports, Alternative Medicine, Other Health, Health, Cannabis, Specialty, Natural Resources, Cosmetics, Retail, Fitness & Nutrition, CFL, Solvent, Certification, Organization, Sport, Therapy, Dietary supplement, Risk, Senior ice hockey, National Hockey League, Good manufacturing practice, LPGA, Ironman, Selective androgen receptor modulator, AFL, Growth hormone, CBD, Massage, Athlete, NHL, GMP, Outline of health sciences, NSF, MLB, CCES, Diuretic, Former, USADA, Good, Sports medicine, Multimedia, NBA, PGA, THC, UFC, Steroid, NFL, NASCAR, Major League Baseball, Nursing

CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.

Key Points: 
  • CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.
  • "The spirit of clean athletic competition is something we all connect with,” said David Lonza, Vice President, Health Sciences 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.

Sudden Hearing Loss: Recent Clinical Trial HODOKORT Questions Benefits of Glucocorticoid Treatment

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화요일, 3월 12, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Speech, Glucocorticoid, Hearing loss, Patient, NEJM, Human, Trial of the century, Huber loss, Clinical trial, Multimedia, Steroid, Pharmaceutical industry

High-dose glucocorticoids are no more effective than the standard-dose in treating patients with sudden hearing loss.

Key Points: 
  • High-dose glucocorticoids are no more effective than the standard-dose in treating patients with sudden hearing loss.
  • This clinical study, led by Prof. Stefan Plontke from the University Medicine Halle, evaluated the efficacy of different doses of glucocorticoids in over 300 sudden hearing loss patients and is published in NEJM Evidence .
  • However, there is no convincing mode-of-action for the treatment of sudden hearing loss with steroids, as our own research has shown," says Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma.
  • After 50 years of treating sudden hearing loss with glucocorticoids, a new and effective drug for this condition would represent a much-needed paradigm shift.

ChestPal™ Pro, a Bluetooth-Connected, Portable, Crackle and Wheeze Detection Innovation, Launches in the U.S. as Early Asthma and Allergy Season Looms

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화요일, 3월 12, 2024
Hardware, Health Technology, Health Insurance, Data Management, Other Health, Technology, Oncology, General Health, Biometrics, Medical Devices, Hospitals, Biotechnology, Software, Health, Medical Supplies, Mobile, Wireless, Diagnosis, MD, Wheeze, COPD, Patient, Lung, Multimedia, Asthma, Steroid, Classification, Pneumonia, Glimpse, Internal medicine, Entrepreneurship

ChestPal™ Pro, the only commercially available digital stethoscope in the U.S. that’s clinically backed to detect, classify, record, and share crackles and wheezes, launches to healthcare practitioners today.

Key Points: 
  • ChestPal™ Pro, the only commercially available digital stethoscope in the U.S. that’s clinically backed to detect, classify, record, and share crackles and wheezes, launches to healthcare practitioners today.
  • This press release features multimedia.
  • ​​For clinicians who need to accurately detect, record, and share classified lung sounds.
  • “ChestPal™ Pro helps pick up lung sounds that are too subtle to hear when using a stethoscope alone,” said Dr. Emily Tuchman, MD, General Internal Medicine.