Nelfinavir

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

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星期二, 二月 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): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

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星期二, 一月 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): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

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星期二, 一月 2, 2024
Liver, Medical Subject Headings, Common, Diarrhea, Marketing, HIV-1, European Commission, Agency, Protease, HIV, INN, Immune system, Upper respiratory tract infection, ATC, Nelfinavir, Depression, EMA, AIDS, International, Capsule, European, Ageing, Nausea, Blood, Language, European Medicines Agency, Infection, Food, Ritonavir, Tablet, Reproduction, Select, Patient, Human, Liver disease, Anatomy, Medicine, IIA, Lopinavir, Viral load, Vaccine

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, 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

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星期三, 十二月 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.

Toragen, Inc. Announces Chief Medical Officer to Drive the Company’s Clinical Development

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星期五, 十月 7, 2022
Biotechnology, Pharmaceutical, Health, Oncology, CA, Therapy, Drug development, Chief medical informatics officer, Senior, Nelfinavir, Medical Affairs Bureau, Biostatistics, Vomiting, Doctor of Philosophy, MD, Pfizer, Cancer, Inc., Leadership, Pharmaceutical industry

Dr. Clendeninn has worked for over 20 years in the pharmaceutical and biotechnology industry and has an established track record of successful drug development.

Key Points: 
  • Dr. Clendeninn has worked for over 20 years in the pharmaceutical and biotechnology industry and has an established track record of successful drug development.
  • Most recently Dr. Clendeninn served as the Senior Vice President and Chief Medical Officer of Heron Therapeutics, in San Diego, CA, where he established the clinical departments including Medical Affairs, Clinical Operations, Clinical Research and Biostatistics.
  • He was instrumental in gaining the approval of SUSTOL, a long-acting granisetron formulation for chemotherapy-induced nausea and vomiting.
  • Dr. Clendininns direct experience in clinical oncology, and his long career in drug development, including anti-virals, is an ideal match for Toragen, and I look forward to his leadership of our Phase I clinical trial.