Chills

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

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Martedì, Gennaio 2, 2024
People, Marketing, INN, Risk, Leukopenia, Hypophosphatemia, Hypotension, Pneumonia, Potassium, Nausea, Cancer, Myenteric plexus, Infection, Anatomy, Cough, IIA, Multiple myeloma, Chills, Consciousness, Diarrhea, Fever, Fatigue, Bone marrow, ATC, Pharyngitis, Pain, Platelet, Disease, Nose, Edema, Neutrophil, Speech, Depression, Appetite, Writing, Lymphocyte, Safety, Water, Tachycardia, Anemia, Neurological disorder, Hypocalcemia, Sepsis, Hypokalemia, Patient, Medical Subject Headings, Febrile neutropenia, Lymphocytopenia, Cytokine release syndrome, International, Encephalopathy, Neutropenia, Blood, Language, Thrombocytopenia, Neurotoxicity, Select, Medicine, Vomiting, Upper respiratory tract infection, Headache, Hospital, BCMA, Confusion, European Medicines Agency, Cell, Medical device

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Refixia, nonacog beta pegol, Date of authorisation: 02/06/2017, Revision: 5, Status: Authorised

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Martedì, Gennaio 2, 2024
Chills, Patient, Medical Subject Headings, Marketing, Lethargy, European Commission, Agency, INN, Allergy, Stinger, ATC, Antibody, Restless, Blood, Bleeding, International, PEG, European, Headache, Haemophilia B, Choroid plexus, Ageing, Nausea, Brain, Language, Profile, Swelling, Haemophilia, Flushing, Combustion, Select, Safety, Anatomy, Medicine, Vomiting, IIA, CHMP, Medical device

Human medicines European public assessment report (EPAR): Refixia, nonacog beta pegol, Date of authorisation: 02/06/2017, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Refixia, nonacog beta pegol, Date of authorisation: 02/06/2017, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

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Martedì, Gennaio 2, 2024
Marketing, PV, INN, Risk, MPA, Shivering, CD20, PML, Pemphigus vulgaris, Inflammation, Infection, Anatomy, Lymphoma, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Nose, Allergy, Glucocorticoid, NHL, CLL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, B cell, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Date of authorisation: 06/03/2009, Revision: 20, Status: Authorised

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Martedì, Gennaio 2, 2024
Marketing, Plasma protein binding, Constipation, INN, Risk, Hypotension, Hypertension, Fatigue, Nausea, Cancer, Inflammation, Tachypnea, Back pain, Chest pain, Diagnosis, Anatomy, Cough, IIA, CHMP, Chills, Diarrhea, Fever, ATC, Pain, European, Disease, Ageing, Weakness, Nonsteroidal anti-inflammatory drug, Human, Tachycardia, Anemia, Arthralgia, Medical Subject Headings, European Commission, Immune system, International, Language, Somatic symptom disorder, Myalgia, Dizziness, Monocyte, Select, Patient, Medicine, Hyperhidrosis, Vomiting, Allergy, Headache, Mifamurtide, Macrophage, Abdominal pain, Hypothermia, Chronic pain, Safety, Committee, Periodic breathing, Medical device

Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Date of authorisation: 06/03/2009, Revision: 20, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Date of authorisation: 06/03/2009, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised

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Martedì, Gennaio 2, 2024
People, Marketing, Immunodeficiency, INN, Risk, Sensation, Messenger, Delta, Nausea, RMP, Vaccination, Heart, Inflammation, Back pain, SARS, Hardness, Bruise, Anatomy, IIA, Odynophagia, Hypoesthesia, Skin, Chills, Diarrhea, Fever, Fatigue, ATC, Pain, Ageing, Pregnancy, Somnolence, Arthralgia, Medical Subject Headings, Agency, Immune system, Allergy, Antibody, EMA, International, Language, Pfizer–BioNTech COVID-19 vaccine, Dizziness, Select, Patient, Vomiting, Erythema, Pericarditis, Lymph, System, Vaccine, Weakness, Headache, Abdominal pain, Swelling, Hypersensitivity, Temperature, COVID-19, SARS-CoV-2, Myalgia, Paresthesia, Rash

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41[...]

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Martedì, Gennaio 2, 2024
People, Marketing, Immunodeficiency, INN, Risk, Woman, Sensation, COVID 19, Messenger, Nausea, Myocarditis, DNA, Erythema multiforme, Vaccination, Heart, Inflammation, COVID, Obesity, Liver disease, Anatomy, Paresthesia, IIA, Skin, Hypoesthesia, Chills, Diarrhea, COVID-19 vaccine, Fever, Fatigue, Infection, ATC, Pain, Palsy, Disease, Ageing, Profile, Omicron, Allergy, Pregnancy, HIV, Thigh, Safety, Somnolence, RNA, Medical Subject Headings, Group, Immune system, HIV/AIDS, Antibody, International, Injection, Crying, Language, Dizziness, Select, Patient, Vomiting, Pericarditis, Anaphylaxis, Arm, System, Vaccine, Diabetes, Headache, Abdominal pain, Clinical trial, Swelling, Hypersensitivity, Irritability, Temperature, COVID-19, European Medicines Agency, Face, Cell, Miscarriage, Rash

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41, Status: Authorised

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

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Martedì, Gennaio 2, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, Pemphigus, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Bone marrow, GPA, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

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Martedì, Dicembre 5, 2023
Chills, CRS, Melanoma, RP1, CRC, Food, Melanoma Research, RECIST, NMSC, Transplant, Diarrhea, FDA, Cytokine release syndrome, Colorectal cancer, SCCHN, Type, RP3, CRR, Fatigue, Headache, Nausea, Itch, Myocarditis, Incidence, Nivolumab, Influenza-like illness, Research, Clinical trial, Injection site reaction, Myalgia, CSCC, Skin cancer, HCC, Weakness, Society, Head, Appetite, RP2, Regeneron Pharmaceuticals, Carcinoma, Investment, Webcast, Patient, Lipase, Angiosarcoma, MCC, Vomiting, Neck, Uveal melanoma, Rash, BLA, Pharmaceutical industry

The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.

Key Points: 
  • The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.
  • The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692).
  • The registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients and completed enrollment earlier this year.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

Protara Therapeutics Announces Presentation of Additional Encouraging Data from Phase 1a ADVANCED-1 Trial of TARA-002 in NMIBC at the 24th Annual Meeting of the Society of Urologic Oncology

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Giovedì, Novembre 30, 2023
Chills, Fever, CIS, Carcinoma, Fatigue, Headache, Urinary bladder, Therapy, Cancer, Society, Urination, BCG, Neoplasm, System, SUO, Bacillus, Patient, NMIBC, Pharmaceutical industry

The data will be featured during a poster session at the 24th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Washington, D.C. from November 28, 2023 through December 1, 2023.

Key Points: 
  • The data will be featured during a poster session at the 24th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Washington, D.C. from November 28, 2023 through December 1, 2023.
  • The patient who did not achieve HGRFS was dosed at 10KE, the lowest dose of TARA-002 offered in the trial.
  • Additional details on the trial design will be featured in a Trial in Progress poster at the SUO meeting.
  • A copy of the SUO posters will be available in the Events and Presentations section of the Company’s website: https://ir.protaratx.com .

Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn

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Martedì, Novembre 28, 2023
HIV-1, Risk, Heartburn, MOA, Enzyme inhibitor, Potassium, FDA, Magnesium, Nausea, PPI, Inflammation, Prescription, Esophagus, Bone fracture, Skin, Chills, Extrapyramidal system, Fever, Vitamin, Breast milk, Infection, Diarrhea, Helicobacter pylori, Indigestion, Bleeding, Disease, Muscle weakness, Tongue, Calcium, Acid, University, Human, Pharmacy, Clostridioides, Vonoprazan, Urine, Hip, B-12, Food, Polyp, Esophagitis, GERD, Chronic pain, Blood, Dizziness, Blister, Gastroesophageal reflux disease, Tablet, Vitamin B12, Scar, Patient, Wrist, Medicine, Seizure, HIV, Stomach, Lymph, Allergy, Clostridioides difficile, Rash, Weakness, Urinary tract infection, Hypoesthesia, Week, Myalgia, Spine, Spasm, Kidney, Face, Rilpivirine, Lansoprazole, Pharmaceutical industry

“We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.

Key Points: 
  • “We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.
  • “Erosive GERD is a highly prevalent condition affecting over 20 million people in the U.S.,3,4 many of whom experience troubling symptoms, including painful heartburn.
  • Phathom is offering programs for eligible patients who face coverage or affordability issues, including co-pay assistance for patients with commercial insurance.
  • for up to 6 months to maintain healing of Erosive Acid Reflux and for relief of heartburn related to Erosive Acid Reflux.