NIAMS

NDRI Receives $3.7 Million Grant from NIH to Continue the Development of NDRI’s Human Tissue and Organs for Research Resource (HTORR) Program

Retrieved on: 
Wednesday, September 6, 2023
Science, Stem Cells, Other Science, Biotechnology, Research, Health, Hospitals, Genetics, NIDDK, Tissue, National Disease Research Interchange, Division of Program Coordination, Planning, and Strategic Initiatives, National Institute of Allergy and Infectious Diseases, Partnership, Arthritis, NEI, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Heart, Lung, and Blood Institute, Skin condition, Lung, Bangladesh Technical Education Board, MS, NHLBI, Kidney, NIAMS, National Eye Institute, National Institute of Diabetes and Digestive and Kidney Diseases, NDRI, Human musculoskeletal system, NIAID, Digestive, NIH, Infection, Pharmaceutical industry, Management

This new three-year award for NDRI’s Human Tissue and Organs for Research Resource (HTORR) Program parent grant extends the NIH’s ongoing funding support for HTORR to 35 consecutive years.

Key Points: 
  • This new three-year award for NDRI’s Human Tissue and Organs for Research Resource (HTORR) Program parent grant extends the NIH’s ongoing funding support for HTORR to 35 consecutive years.
  • The HTORR Program supports investigators across the full spectrum of research with access to normal and diseased human biospecimens.
  • “NDRI is grateful to the NIH for the support of our expanding HTORR program,” said Bill Leinweber, President and CEO of NDRI.
  • This grant renewal includes multiple enhancements such as a new Pilot Program, Pathology Service Options, and a Pathology Consultant Committee.

European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, October 31, 2022
Safety, NINDS, Leber's hereditary optic neuropathy, Vomiting, LHON, JAMA Network Open, Vamorolone, Microdeletion syndrome, EC, Vitamin D deficiency, Cystic fibrosis, CMO, Dissociative, Patient, UK, Time, Foundation, EMA, JAMA, NCATS, Review, JAMA Neurology, Committee for Medicinal Products for Human Use, DMD, European Medicines Agency, Orphan drug, Food and Drug Administration Amendments Act of 2007, Life Science Alliance, CHMP, FDA, National, Defense, National Institutes of Health, Adolescence, Food, PIM, NIAMS, NDA, Muscular dystrophy, Company, Duchenne muscular dystrophy, Union, European Commission, MAA, Vaccine, Pharmaceutical industry, Wood drying, MD, Duchenne

Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

Key Points: 
  • Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
  • Subject to EC approval, expected later in 2023, vamorolone will receive marketing authorization in all member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
  • Santhera has submitted a new drug application (NDA) to the U.S. FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of DMD.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, October 27, 2022
JAMA Neurology, Life expectancy, Union, Muscular dystrophy, PIM, European Medicines Agency, UK, Vamorolone, NINDS, FDA, Dissociative, Ventilation, National Institutes of Health, MAA, Foundation, JAMA Network Open, Inflammation, CEO, Vitamin D deficiency, Food, Patient, Maintenance, Life Science Alliance, Cardiomyopathy, NDA, Heart, Orphan drug, Duchenne muscular dystrophy, Defense, EMA, NIAMS, Company, Weakness, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Doctor of Philosophy, Safety, Disease, LHON, DMD, National, European Commission, Leber's hereditary optic neuropathy, Adolescence, NCATS, Fibrosis, Microdeletion syndrome, Prednisone, Cystic fibrosis, Vomiting, Caregiver, Time, Pharmaceutical industry, Duchenne, MD

Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.

Key Points: 
  • Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.
  • With the completion of the rolling NDA submission, Santhera and ReveraGen have also applied for priority review.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.
  • The development of ReveraGens lead compound, vamorolone, has been supported through partnerships with foundations worldwide, including Muscular Dystrophy Association USA, Parent Project Muscular Dystrophy, Foundation to Eradicate Duchenne, Save Our Sons, JoiningJack, Action Duchenne, CureDuchenne, Ryans Quest, Alexs Wish, DuchenneUK, Pietros Fight, Michaels Cause, Duchenne Research Fund, and Defeat Duchenne Canada.

Santhera and ReveraGen Announce Presentations on Long-Term Efficacy and Bone Health in DMD During Vamorolone Treatment at the 2022 World Muscle Society Congress

Retrieved on: 
Monday, October 10, 2022
National Institutes of Health, Congress, Body mass index, Life Science Alliance, Vamorolone, WMS, Prednisone, NCATS, NINDS, Patient, Muscular dystrophy, JAMA Neurology, Orphan drug, Cystic fibrosis, NIAMS, DMD, UK, Duchenne muscular dystrophy, Adolescence, Company, ADT, LHON, Doctor of Philosophy, Leber's hereditary optic neuropathy, National, Muscle, PIM, Safety, Foundation, Dissociative, FDA, JAMA Network Open, Defense, European Commission, Pharmaceutical industry, Online gambling, Duchenne, MD

Santhera is hosting an on-site scientific exhibit (booth #4, located in the Ballroom Salon) where medical representatives of the Company will be present throughout the conference.

Key Points: 
  • Santhera is hosting an on-site scientific exhibit (booth #4, located in the Ballroom Salon) where medical representatives of the Company will be present throughout the conference.
  • Vamorolone is an investigational medicine and is currently not approved for use by any health authority.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.
  • ReveraGen has also received generous support from the US Department of Defense CDMRP, National Institutes of Health (NCATS, NINDS, NIAMS), and European Commission (Horizons 2020).

Santhera Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, October 3, 2022
Review, JAMA Network Open, Duchenne muscular dystrophy, Vamorolone, NCATS, Weakness, NDA, PIM, MAA, Vitamin D deficiency, Food and Drug Administration Amendments Act of 2007, National, EMA, Life Science Alliance, Vomiting, Time, Patient, Life expectancy, European Medicines Agency, Adolescence, Leber's hereditary optic neuropathy, Foundation, CMO, Microdeletion syndrome, Inflammation, DMD, JAMA Neurology, NINDS, Food, NIAMS, Prednisone, Fibrosis, FDA, Dissociative, LHON, Heart, JAMA, Company, Maintenance, Cystic fibrosis, National Institutes of Health, Ventilation, Disease, European Commission, Defense, Muscular dystrophy, Safety, Cardiomyopathy, Orphan drug, UK, Pharmaceutical industry, Wood drying, Duchenne, EU, MD

Pratteln, Switzerland, October3, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

Key Points: 
  • Pratteln, Switzerland, October3, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
  • Duchenne is a debilitating disease with patients in need for effective and well-tolerated therapies, said Shabir Hasham, MD, CMO of Santhera.
  • In the U.S., Santhera expects to complete the filing of the new drug application (NDA) for vamorolone in DMD to the Food and Drug Administration (FDA) in Q4-2022.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

Nominations Open for 10th Annual International Harrington Prize for Innovation in Medicine

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Monday, July 25, 2022
Lecture, University Hospitals Cleveland Medical Center, NHLBI, Association, Antibody, Diabetes, Rockefeller University, NIH, Society, University, NIAMS, Disorder, Sickle cell disease, Doctor of Philosophy, American Physician Scientists Association, CAR, Human papillomavirus infection, Massachusetts General Hospital, Leptin, Lists of diseases, Vanderbilt University, Marfan syndrome, Mount Sinai Hospital, National Cancer Institute, LDL, COVID-19, Cervical cancer, All India Mahila Congress, Thalassemia, Organization, Journal, University of Texas Southwestern Medical Center, Creativity, Science, List, Patient, University of Copenhagen, University of Pennsylvania, Biology, American Society for Clinical Investigation, PCSK9, ASCI, APSA, Johns Hopkins University, AAP, Harvard University, Pharmaceutical industry, Vaccine, Medicine, MD

CLEVELAND, July 25, 2022 /PRNewswire/ -- National and international nominations are being sought for the 2023 Harrington Prize for Innovation in Medicine, which honors a physician-scientist who has moved science forward with achievements notable for innovation, creativity and the potential for clinical application. 

Key Points: 
  • CLEVELAND, July 25, 2022 /PRNewswire/ --National and international nominations are being sought for the 2023 Harrington Prize for Innovation in Medicine, which honors a physician-scientist who has moved science forward with achievements notable for innovation, creativity and the potential for clinical application.
  • The Harrington Prize, which carries a $20,000 honorarium, is a collaboration between Harrington Discovery Institute at University Hospitals in Cleveland, Ohio and the American Society for Clinical Investigation (ASCI), one of the nation's oldest and most respected medical honor societies.
  • Harrington Discovery Institute is a nonprofit institute dedicated to helping physician-scientists accelerate promising discoveries into medicines for unmet needs.
  • A committee composed of members of the Harrington Discovery Institute Scientific Advisory Board and the ASCI Council will review the nominations and select the awardee.

Santhera and ReveraGen to Present Efficacy and Safety Data with Vamorolone at 2022 Muscular Dystrophy Association Conference

Retrieved on: 
Tuesday, March 15, 2022
NorthStar, Muscular dystrophy, Muscular Dystrophy Association, DMD, Mark (given name), Conference, US FDA, Orphan drug, Leber's hereditary optic neuropathy, Defense, European Commission, Prednisone, Time, NDA, Vamorolone, NINDS, Cystic fibrosis, Biomarker, Duchenne muscular dystrophy, Growth, UK, NIAMS, Patient, Foundation, Microdeletion syndrome, Episcopal conference, PIM, National Institutes of Health, Vitamin D deficiency, MDA, Vomiting, Safety, National, Company, NCATS, LHON, Pharmaceutical industry, MD, Duchenne

Pratteln, Switzerland, and Rockville, MD, USA, March 15, 2022 Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of efficacy and tolerability data with vamorolone in Duchenne muscular dystrophy (DMD) at the 2022 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 13-16, 2022, Nashville, TN, USA).

Key Points: 
  • Pratteln, Switzerland, and Rockville, MD, USA, March 15, 2022 Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of efficacy and tolerability data with vamorolone in Duchenne muscular dystrophy (DMD) at the 2022 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 13-16, 2022, Nashville, TN, USA).
  • A rolling NDA submission to the U.S. FDA for vamorolone for the treatment of DMD is planned to start at the end of March 2022.
  • These findings align with vamorolones longer term durable efficacy and safety profile with the potential to offer an alternative to current standard of care.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

NIH Awards Imbed Biosciences $800K SBIR Grant to Kill Bacteria in Biofilms

Retrieved on: 
Thursday, October 14, 2021
Research, Medical Devices, Infectious Diseases, Contracts, Biotechnology, Health, General Health, Other Science, Science, Biofilm, IMB Bank, List of life sciences, Amputation, National Institute, Architecture, Principal investigator, Infection, CRP, Septic shock, Wound healing, Skin condition, School, National Institute of Arthritis and Musculoskeletal and Skin Diseases, FDA, Multimedia, Small Business Innovation Research, Veterinary medicine, National, Narayana Multispeciality Hospital, Mysore, SBIR, Critical care, Ion, Silver, University, Bacteria, Burns, CEO, NIH, Matrix, NIAMS, MD, List of Christian mission hospitals, Research, Surgery, Human musculoskeletal system, Pharmaceutical industry, Antibiotics

View the full release here: https://www.businesswire.com/news/home/20211014005922/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20211014005922/en/
    Microlyte(R) Matrix and Microlyte(R) SURGICAL are available in a variety of sizes and are able to kill the bacteria associated with chronic wounds and surgical site infections.
  • Both products have been associated clinically with improved healing outcomes in a variety of acute, chronic, and traumatic wounds.
  • (Photo: Business Wire)
    Biofilms are colonies of bacteria on a surface that are insensitive to systemic antibiotics and topical antimicrobials.
  • The microscale architecture of Microlyte Matrix, which intimately conforms to a wound surface, will facilitate the synergistic action of the two metal ions to penetrate biofilms and kill multispecies bacteria hidden inside.

Applied Molecular Transport to Host Virtual Research & Development Day on October 15, 2021

Retrieved on: 
Monday, October 11, 2021
NIAMS, GMP, Autoimmunity, Biology, IE, Development, GLOBE, IBD, AMT, Review, Rheumatology, CA, AMTI, NIH, Disease, Nasdaq, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Oct. 11, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that the company will host a virtual Research & Development Day on Friday, October 15, 2021, from 11:00 a.m. – 1:00 p.m. ET. The webcast event will focus on a review of the company’s novel oral biologics technology platform, clinical programs and research activities.

Key Points: 
  • Management to highlight novel oral biologics technology platform, clinical programs and research activities
    SOUTH SAN FRANCISCO, Calif., Oct. 11, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that the company will host a virtual Research & Development Day on Friday, October 15, 2021, from 11:00 a.m. 1:00 p.m.
  • The webcast event will focus on a review of the companys novel oral biologics technology platform, clinical programs and research activities.
  • Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases.
  • Active transport is an efficient mechanism that uses the cells own machinery to transport materials across the IE barrier.

ReveraGen and Santhera Announce FDA Orphan Grant Funding for Clinical Trial with Vamorolone in Becker Muscular Dystrophy

Retrieved on: 
Monday, September 27, 2021
BMD, University, Dystrophin, Program, Safety, Wilfrid Sellars, UK, National, Arthritis, NCATS, PIM, Cystic fibrosis, Orphan drug, Clinical trial, Duchenne muscular dystrophy, PMID, Vamorolone, NDA, MicroRNA, FDA, National Institutes of Health, Muscular dystrophy, Leber's hereditary optic neuropathy, Degenerative disease, Neurology, European Commission, LHON, Foundation, Doctor of Philosophy, University of Pittsburgh School of Medicine, Muscle weakness, Becker muscular dystrophy, NINDS, Patient, Adolescence, Defense, NIAMS, DMD, NIH, Pharmaceutical industry, Dietary supplement, Vaccine

The grant adds to existing grants from the National Institutes of Health, NIAMS, and the Foundation to Eradicate Duchenne to initiate a clinical trial of vamorolone in adults and children with Becker muscular dystrophy, a progressive muscle wasting disease similar to Duchenne muscular dystrophy, but usually milder.

Key Points: 
  • The grant adds to existing grants from the National Institutes of Health, NIAMS, and the Foundation to Eradicate Duchenne to initiate a clinical trial of vamorolone in adults and children with Becker muscular dystrophy, a progressive muscle wasting disease similar to Duchenne muscular dystrophy, but usually milder.
  • Vamorolone, a dissociative steroid drug, that has shown retention of efficacy and reduction of safety concerns typically associated with corticosteroids in Duchenne muscular dystrophy (DMD) will now be tested in a 24-week clinical exploratory trial in Becker muscular dystrophy (BMD).
  • The double-blind trial will test efficacy and safety of daily vamorolone on motor outcomes and established biomarker outcomes, with participants randomized 2:1 vamorolone or placebo.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.