Ulcerative colitis

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 45, Status: Authorised

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Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Agency, TNF, INN, Immune system, Etanercept, Ulcerative colitis, Adolescence, Caregiver, PUVA, ATC, Joint, Crohn's disease, Psoriatic arthritis, Bleeding, International, Headache, Disease, Common, Ageing, Nose, Language, Arthritis, Inflammation, Hypersensitivity, Allergy, Disease-modifying antirheumatic drug, European Medicines Agency, Ulcer, Select, Anatomy, Methotrexate, IIA, DMARD, Skin, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 45, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 45, Status: Authorised

Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Marketing, MP, Heart, MRI, INN, Risk, MTX, Pneumonia, Fungus, AZA, UC, Eating, Inflammation, Ankylosing spondylitis, Infection, Fungal infection, Diagnosis, Anatomy, Ulcer, Lymphoma, IIA, Skin, Vasculitis, Yeast, Psoriasis, ATC, Joint, Pain, Psoriatic arthritis, Syringe, Disease, Nose, Allergy, Lower respiratory tract infection, Nonsteroidal anti-inflammatory drug, Hepatitis B virus, Safety, Heart failure, CRP, Disorder, Rheumatoid arthritis, Sepsis, Magnetic resonance imaging, Leukemia, Patient, Medical Subject Headings, Walking, Immune system, Ulcerative colitis, International, Arthritis, Language, Blood, Hepatitis B, Medication package insert, Tuberculosis, Select, Medicine, Methotrexate, Azathioprine, TNF, X-ray, Mercaptopurine, European Medicines Agency, Spine, DMARD, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

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

Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Date of authorisation: 26/07/2018, Revision: 14, Status: Authorised

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

Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Date of authorisation: 26/07/2018, Revision: 14, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Date of authorisation: 26/07/2018, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Flixabi, infliximab, Date of authorisation: 26/05/2016, Revision: 24, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, Contraindication, INN, Risk, AZA, Nausea, Heart, Inflammation, Disease-modifying antirheumatic drug, Infection, Diagnosis, Risk management, Anatomy, Ulcer, IIA, CHMP, Skin, Sinusitis, ATC, Joint, Pain, Psoriatic arthritis, Drainage, European, Disease, Ageing, Human, Safety, Heart failure, Rheumatoid arthritis, Medical Subject Headings, Agency, European Commission, Immune system, Ulcerative colitis, ACR, International, Arthritis, Language, Blood, Ciclosporin, Viral, Tuberculosis, Select, Patient, Medicine, Methotrexate, Azathioprine, Common, Tumor necrosis factor, Allergy, PUVA, Glycine mollis, Headache, Abdominal pain, Ankylosing spondylitis, Spine, Chronic pain, Committee, DMARD, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Flixabi, infliximab, Date of authorisation: 26/05/2016, Revision: 24, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Flixabi, infliximab, Date of authorisation: 26/05/2016, Revision: 24, Status: Authorised

EQS-News: Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

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Saturday, December 30, 2023
Fresenius (company), Food, EMA, FDA, Biologics license application, Ulcerative colitis, Press release, Ustekinumab, Patient, Psoriasis, Biosimilar, BLA, Generic drug

Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Key Points: 
  • Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    The issuer is solely responsible for the content of this announcement.
  • Press Release // November 30, 2023
    Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara®1.
  • FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders.
  • “The FDA file acceptance for our Stelara® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon.

First Wave BioPharma Announces Streamlining of Clinical Pipeline with Non-Binding Term Sheet to Sell Niclosamide IBD Program

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Wednesday, December 27, 2023
IBD, Food, Economics, Diarrhea, FDA, WHO, Exocrine pancreatic insufficiency, COVID, BOCA, Intellectual property, Infection, World Health Organization, First wave, Patient, Inflammatory Bowel Diseases, Ulcerative colitis, Pharmaceutical industry

The non-binding term sheet includes a low seven-figure upfront payment to First Wave BioPharma for rights to Niclosamide, as well as economics related to future milestones and royalties.

Key Points: 
  • The non-binding term sheet includes a low seven-figure upfront payment to First Wave BioPharma for rights to Niclosamide, as well as economics related to future milestones and royalties.
  • Additional details of the transaction will be disclosed upon finalization and execution of the definitive agreement.
  • The drug is a potential non-steroidal anti-inflammatory therapy for the treatment of mild-to-moderate inflammatory bowel diseases (IBD).
  • Intellectual property for niclosamide formulations governing composition of matter and methods of use extends beyond 2040.

Aclaris Therapeutics Provides Corporate Update

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Tuesday, December 19, 2023
Workforce, Atopic dermatitis, Osteoporosis, Therapy, Clinical trial, Pharmacokinetics, Kinect, Professional, MK2, Pancreatic cancer, Patient, Safety, ACRS, Ulcerative colitis, Pharmaceutical industry

WAYNE, Pa., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced several corporate updates.

Key Points: 
  • WAYNE, Pa., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced several corporate updates.
  • First, Aclaris announced the publication of the Phase 2a trial results of ATI-1777 in moderate to severe atopic dermatitis (AD) in the peer-reviewed journal JID Innovations on November 27, 2023.
  • Based on these results, Aclaris progressed ATI-1777 into a Phase 2b trial in patients with mild to severe AD.
  • Aclaris plans to use ATI-450 instead of ATI-2231, its second MK2 inhibitor, due to ATI-450’s more advanced clinical development package.

MORF NEWS: Johnson Fistel has Commenced an Investigation on Behalf of Morphic Holding Company Shareholders

Retrieved on: 
Tuesday, December 19, 2023
Cancer, System, Patient, News, Therapy, Fibrosis, DSM-IV codes, Ulcerative colitis, SAN, Autoimmunity, Pharmaceutical industry

SAN DIEGO, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Johnson Fistel, is investigating potential securities claims against Morphic Holding, Inc. (NASDAQ: MORF) on behalf of stockholders.

Key Points: 
  • SAN DIEGO, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Johnson Fistel, is investigating potential securities claims against Morphic Holding, Inc. (NASDAQ: MORF) on behalf of stockholders.
  • The investigation focuses on investors’ losses and whether they may be recovered under federal securities laws.
  • Morphic Holding, Inc, a biopharmaceutical company, discovers and develops oral small-molecule integrin therapeutics for the treatment of autoimmune, cardiovascular, and metabolic diseases, as well as fibrosis and cancer.
  • Individuals with nonpublic information regarding the company should consider whether to assist our investigation or take advantage of the SEC Whistleblower program.

Biora Therapeutics Announces New Patent for its NaviCap™ Targeted Oral Delivery Platform

Retrieved on: 
Tuesday, December 19, 2023
Janus, Disease, Tyrosine kinase inhibitor, Dicarboxylic acid, Antibody, Inflammatory bowel disease, B cell, Gastrointestinal disease, Patent, Integrin, Gastrointestinal tract, SAN, Therapy, JAK, GI, IP, Device, Janus kinase, Peptide, United States patent law, Chemokine, Ulcerative colitis, Pharmaceutical industry

SAN DIEGO, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .

Key Points: 
  • SAN DIEGO, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it received an Issue Notification from the U.S. Patent and Trademark Office for a patent related to the treatment of gastrointestinal (GI) disorders through targeted delivery of JAK inhibitors for its NaviCap™ targeted oral delivery platform under development.
  • 17/313,339, entitled “Treatment of a Disease of the Gastrointestinal Tract with a JAK Inhibitor and Devices,” will issue as US Patent No.
  • The patent covers many JAK inhibitors, including those that are approved or in development for a range of indications.