Ulcerative colitis

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara® (Ustekinumab)

Retrieved on: 
Friday, January 5, 2024
Health, FDA, Other Health, Research, Science, Pharmaceutical, Biotechnology, Food, Ustekinumab, EMA, MAA, Intas Pharmaceuticals, Inflammation, USD, IQVIA, Ulcerative colitis, CSO, Patient, Safety, Psoriasis, Psoriatic arthritis, BLA, Pharmaceutical industry

The BLA leverages the analytical similarity assessment data between EU and US sourced Stelara® and DMB-3115.

Key Points: 
  • The BLA leverages the analytical similarity assessment data between EU and US sourced Stelara® and DMB-3115.
  • It recorded USD 17.77 billion in sales (IQVIA Accumulative Sales) in 2022 and is one of the world’s best-selling biologics.
  • The rights of Dong-A Socio Holdings for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management.
  • Intas Pharmaceuticals plans to commercialize DMB-3115 through Accord BioPharma (US), Accord Healthcare (EU, UK, and Canada), and other subsidiaries around the world.

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Marketing, INN, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Pediatrics, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Methotrexate, TNF, Axial, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Frankincense

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

EQS-News: Immunic Highlights 2023 Accomplishments and Upcoming Milestones

Retrieved on: 
Friday, January 5, 2024
Janus, Biotechnology, Conference, MRI, Serum, Histology, Regeneration, PMS, Multiple sclerosis, Woman, Disease, Calcium, Clinical trial, Investment, AFL, SIRT6, Medicinal chemistry, Ulcerative colitis, Biomarker, Journal of Medicinal Chemistry, DHODH, Patient, Journal, RMS, Magnetic resonance imaging, Pharmaceutical industry

“With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.

Key Points: 
  • “With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.
  • A more thorough review of recent events and upcoming milestones follows:
    Announced a three-tranche private placement of up to $240 million with participation from select new and existing investors today.
  • Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential.
  • Immunic believes this data provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

Immunic Highlights 2023 Accomplishments and Upcoming Milestones

Retrieved on: 
Friday, January 5, 2024
Janus, Biotechnology, Conference, MRI, Serum, Histology, Regeneration, Entire, PMS, Multiple sclerosis, Woman, Disease, Sirtuin 6, Calcium, Clinical trial, Investment, AFL, SIRT6, Medicinal chemistry, Ulcerative colitis, Biomarker, Journal of Medicinal Chemistry, DHODH, Patient, Journal, RMS, Magnetic resonance imaging, Pharmaceutical industry

"With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.

Key Points: 
  • "With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.
  • A more thorough review of recent events and upcoming milestones follows:
    Announced a three-tranche private placement of up to $240 million with participation from select new and existing investors today.
  • Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential.
  • Immunic believes this data provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115

Retrieved on: 
Thursday, January 4, 2024
Biology, Partnership, Food, Pegfilgrastim, Johnson & Johnson, Trastuzumab, Crohn's disease, FDA, Filgrastim, Ulcerative colitis, PASI, Intas Pharmaceuticals, Ustekinumab, Patient, Safety, Psoriasis, Medicine, BLA, Pharmaceutical industry

DURHAM, N.C., Jan. 4, 2024 /PRNewswire/ -- Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115. DMB-3115 is a proposed biosimilar to STELARA®, a blockbuster drug developed by Janssen Biotech, Inc. and approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.

Key Points: 
  • In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.
  • The announcement of DMB-3115's BLA acceptance comes as Accord BioPharma awaits a string of additional regulatory milestones.
  • The company has submitted three separate Biologics License Applications to the FDA for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim.
  • Accord BioPharma is planning to introduce several additional biosimilars to the U.S. market during the next five years.

Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Liver, Medical Subject Headings, Fungal infection, Marketing, European Commission, INN, Stomach, Allergy, Itraconazole, Saquinavir, ATC, Glass, Nelfinavir, Depression, Kidney disease, Bleeding, International, European, Megacolon, Disease, Urinary retention, Language, Muscle weakness, Urinary bladder, Inflammation, Nefazodone, Water, Peanut, Ulcerative colitis, Colitis, Ketoconazole, Ritonavir, Tablet, Hyperkinesia, Indinavir, CYP3A4, Xerostomia, Select, Committee, Urination, Patient, Liver disease, Atazanavir, Anatomy, Medicine, Clarithromycin, IIA, CHMP, Medical device

Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Pediatrics, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Methotrexate, TNF, Axial, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Frankincense

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, MRI, INN, Contraindication, AZA, Axial spondyloarthritis, Rash, Tissue, ACR20, Heart, Cancer, Inflammation, Red, Disease-modifying antirheumatic drug, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, Adolescence, ATC, Joint, Crohn's disease, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Ageing, Nonsteroidal anti-inflammatory drug, Blood, Safety, Heart failure, CRP, Rheumatoid arthritis, Patient, Medical Subject Headings, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Select, Methotrexate, Azathioprine, TNF, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Child, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised