Stevens–Johnson syndrome

Herbal medicinal product: Echinaceae purpureae herbaArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024
Key, Allergy, European Commission, Committee, Infection, Monograph, Asteraceae, Plant, Asthma, Skin, Date, Echinacea, Mouth, Safety, Civil service commission, Common, Rash, Anaphylaxis, Patient, Medicine, Stevens–Johnson syndrome, Community, Herbal medicine, Wound healing, Medicinal plants

Herbal medicinal product: Echinaceae purpureae herbaArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Echinaceae purpureae herbaArray, C: ongoing call for scientific data

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Tuesday, February 13, 2024
Urinary tract infection, Gastroesophageal reflux disease, Research, Heartburn, Toxicity, Magnesium, Polyp, Liver, CYP, CGA, Achlorhydria, Esophagitis, Patient, PBM, Vitamin B12, Vonoprazan, Kidney, Spine, Lactation, Absorption, Hypokalemia, SCAR, Calcium, Express Scripts, TIN, Endoscopy, Tablet, Express, Magnesium deficiency, Hypocalcemia, Diarrhea, Hypersensitivity, Physician, Gastritis, Malabsorption, GERD, PPI, Hypertension, SJS, Enzyme inhibitor, EGFR, Stevens–Johnson syndrome, Indigestion, Nelfinavir, Clostridioides, Abdominal pain, Hip, Pharmacy, Enzyme, Glomus tumor, FDA, CDAD, Atazanavir, Risk, BMJ Open, Wrist, Drug, Impairment, Pharmaceutical industry

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

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

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

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

Phathom Pharmaceuticals Announces FDA Acceptance for Filing of VOQUEZNA® (vonoprazan) Tablets New Drug Application for the Treatment of Heartburn Associated with Non-Erosive GERD

Retrieved on: 
Wednesday, December 6, 2023
Quality of life, CYP, Kidney, Risk, Heartburn, Enzyme inhibitor, FDA, TIN, Hypertension, Achlorhydria, Magnesium, Liver, PPI, SJS, Magnesium deficiency, Chest pain, Atazanavir, Endoscopy, Impairment, SCAR, Vitamin B12, Malabsorption, Absorption, PDUFA, CDAD, Calcium, New Drug Application, Gastritis, Enzyme, Food and Drug Administration, Clostridioides, Vonoprazan, Patient, Hip, Hypokalemia, Food, Polyp, GERD, Nelfinavir, Toxicity, EGFR, Wrist, Diarrhea, Hypocalcemia, NDA, Abdominal pain, Urinary tract infection, Hypersensitivity, Stevens–Johnson syndrome, Glomus tumor, Spine, Indigestion, Drug, CGA, Lactation, Pharmaceutical industry

The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.

Key Points: 
  • The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
  • “Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals and impacting their quality of life.
  • Symptoms impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.

Seagen to Highlight Overall Survival Data for PADCEV® and TIVDAK® during Presidential Symposium at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, Fatal, Weakness, Female, Skin, PD-L1, Creatinine, DKA, Nausea, Swelling, Keratitis, Pneumonia, Birth, PD-1, Hair, Neutrophil, Male, Peripheral neuropathy, Lipase, Acute kidney injury, Blood, Stevens–Johnson syndrome, Toxic epidermal necrolysis, Diabetic neuropathy, Toxicity, Bulla, Temperature, Appetite, Itch, SJS, Fetus, Cornea, Conjunctivitis, Hyperglycemia, Dermatitis, Evaluation, Hypoxia, Pain, Diabetic ketoacidosis, Pembrolizumab, ILD, Risk, Liver, Lymphocyte, Grade 2, Rash, Erythema, Fatigue, Acral lentiginous melanoma, Pneumonitis, Papule, Incidence, Dysgeusia, Anemia, Cough, Urinary tract infection, Diarrhea, Erythroderma, Periodic breathing, TEN, Patient, MUC, PN, Drug eruption, Septic shock, Pharmaceutical industry, Medical imaging, Palladium

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Key Points: 
  • Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.
  • When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate.
  • Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCEV in combination with pembrolizumab in clinical trials.
  • The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.

Pfizer Presents New Data at IDWeek 2023 Highlighting Advances in Prevention and Treatment of Certain Respiratory Illnesses and Other Infectious Diseases

Retrieved on: 
Thursday, October 5, 2023
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, COVID-19, Clinical Trials, Pain, Shenzhen Kangtai Biological Products, Food, Gram-negative bacteria, Preterm birth, Act, Death, Ritonavir, Plasma, Treatment, Myalgia, Stevens–Johnson syndrome, EUA, Risk, Hospital, Jaundice, Emergency Use Authorization, Nausea, Allergy, Microsome, Headache, Fatigue, CYP3A, Immune system, Safety, History, Regulation of tobacco by the U.S. Food and Drug Administration, Gestational age, Post-exposure prophylaxis, Anaphylaxis, Patient, Medicine, Vaccine, Pharmaceutical industry, Birth control

PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Key Points: 
  • PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
  • There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended.
  • Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID.
  • Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions:
    Microsomal triglyceride transfer protein inhibitor: lomitapide