Dysgeusia

New US product, ORMALVI™ (dichlorphenamide) tablets, launches for Primary Periodic Paralysis (PPP) treatment

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수요일, 5월 8, 2024
FDA, General Health, Pharmaceutical, Health, Fetus, Cardiomyopathy, Torrent, Acidosis, Respiratory acidosis, Full, Diclofenamide, Risk, Pregnancy, Cognitive disorder, Milk, Aspirin, Metabolic acidosis, Dysgeusia, Hyperkalemia, Aplastic anemia, Partnership, PPP, Agranulocytosis, Anorexia nervosa, Human, Carbonic anhydrase inhibitor, SVP, Tablet, Incidence, Patient, Nursing, Lethargy, Serum, Hyperkalemic periodic paralysis, Diagnosis, Myopathy, Hypokalemic periodic paralysis, Paralysis, Paresthesia, Cycle, Stevens–Johnson syndrome, Hypokalemia, Quality of life, Argyreia nervosa, Sulfonamide, Coma, Pharmaceutical industry

We want to provide them with the support that they require to effectively manage their PPP.

Key Points: 
  • We want to provide them with the support that they require to effectively manage their PPP.
  • ORMALVI™ is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
  • Simply Stated: Research Updates in Periodic Paralysis - Quest | Muscular Dystrophy Association [online] Available at: https://mdaquest.org/simply-stated-research-updates-in-periodic-paralysis Accessed 23 Nov. 2023.
  • The impact of permanent muscle weakness on quality of life in periodic paralysis: a survey of 66 patients.

FDA Approves New Antibiotic for Three Different Uses

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수요일, 4월 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

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화요일, 1월 2, 2024
Blood pressure, Patient, Medical Subject Headings, Marketing, DSM-IV codes, INN, Risk, Rupture, ATC, Depression, System, Bleeding, International, Headache, Nausea, Language, Brain, Dizziness, Vertigo, MADRS, Emotion, European Medicines Agency, Select, Cell, Overalls, Safety, NMDA, Anatomy, Somnolence, SSRI, IIA, SNRI, Dysgeusia, Hypoesthesia, Vomiting, Medical device

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 70, Status: Authorised

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화요일, 1월 2, 2024
Liver, Medical Subject Headings, Peripheral neuropathy, Diarrhea, Marketing, Zidovudine, European Commission, Protease, Pharyngitis, INN, Immune system, Heartburn, HIV/AIDS, Fatigue, Saquinavir, Darunavir, ATC, Depression, Itch, Ritonavir, AIDS, International, Capsule, Cough, European, Headache, Disease, CD4, Ageing, Body surface area, Blood, Sore throat, Nausea, Rash, Language, Mouth, Abdominal pain, Dizziness, Flushing, Infection, Food, Indigestion, HIV, Tablet, Chronic pain, Reproduction, Back pain, Select, Committee, Patient, Dysgeusia, Risk management, Anatomy, Medicine, Paresthesia, Vomiting, IIA, Lopinavir, CHMP, Viral load, Vaccine

Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 70, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 70, Status: Authorised

EQS-News: MorphoSys’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3 MANIFEST-2 Study 

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토요일, 12월 30, 2023
Spleen, Patient, EST, Food, TNF, Survival, Constipation, Bone marrow, BET, Prognosis, Diarrhea, Plasma, Anemia, Fatigue, Headache, Disease, Nausea, GMT, Ruxolitinib, Thrombocytopenia, Weakness, Dizziness, ASH, JAK, MorphoSys, COVID-19, Periodic breathing, European Medicines Agency, IL-6, PST, Development, Fibrosis, Cough, Dysgeusia, FACP

Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.

Key Points: 
  • Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
  • Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes.
  • Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib.
  • “The four hallmarks of myelofibrosis – enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms – have a strong impact on a patient’s life.

Scilex Holding Company Announces Market Research Results with Neurologists, Headache Specialists, and Primary Care Physicians Demonstrating Potential High Unmet Needs In Treating Acute Migraine Targeted By ELYXYB® with Potential Advantages Compared to Cal

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수요일, 11월 22, 2023
Sound, Conference, Contraindication, Migraine, Physician, Disability, CGRP, Chronic pain, Calcitonin gene-related peptide, Headache, Nausea, PALO, MRF, Light, Neurology, Exhibition, Patient, Dysgeusia, Pharmaceutical industry

A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2 Clinicians stated their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use.

Key Points: 
  • A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2 Clinicians stated their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use.
  • ELYXYB’s product profile mapped with a high degree of certainty to these stated unmet needs.
  • In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in nearly 50% of patients.
  • Approximately 34% of patients were pain free at two hours.3 Notably, these data are well differentiated from two other new oral migraine medications of a different class, calcitonin gene-related peptide (CGRP) receptor antagonists.

MorphoSys’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3 MANIFEST-2 Study

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월요일, 12월 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Cough, FACP, Spleen, PST, Food, European Medicines Agency, JAK, GMT, ASH, Headache, Plasma, Disease, Constipation, IL-6, Fatigue, MorphoSys, Patient, Thrombocytopenia, CET, Periodic breathing, Weakness, COVID-19, Prognosis, Diarrhea, Nausea, Survival, EST, Dysgeusia, TNF, Anemia, Fibrosis, Ruxolitinib, BET, Bone marrow, Dizziness, Vaccine, Dietary supplement, Medical imaging

Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.

Key Points: 
  • Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
  • Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes.
  • Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib.
  • “The four hallmarks of myelofibrosis – enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms – have a strong impact on a patient’s life.

C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

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수요일, 11월 1, 2023
Neoplasm, Controlled Impact Demonstration, Research, NSCLC, Public expenditure, National Medical Products Administration, Dexamethasone, Disease, CRC, Annual general meeting, Security (finance), Melanoma, BRAF, Wind, Caregiver, Roche, NHL, Safety, Therapy, Patient, Administration, BRAF V600, Research and development, Plasma, CCCC, Xerostomia, G&A, Conference, CTA, Synovial sarcoma, TPD, Clinical trial, ODI, Anemia, BRD9, Finance, Fatigue, Half-life, NMPA, Aes, Strategic planning, Colorectal cancer, R, High-level radioactive waste management, RECIST, Lung cancer, Combination therapy, Neutropenia, Pharmaceutical industry, Cryptocurrency, Fine chemical, Vaccine, Video game, Dysgeusia, Biogen

WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported financial results for the third quarter ended September 30, 2023, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the third quarter of 2023 was $11.1 million, compared to $6.8 million for the third quarter of 2022.
  • Research and Development (R&D) Expense: R&D expense for the third quarter of 2023 was $28.3 million, compared to $29.7 million for the third quarter of 2022.
  • Net Loss and Net Loss per Share: Net loss for the third quarter of 2023 was $27.0 million, compared to $32.0 million for the third quarter of 2022.
  • Net loss per share for the third quarter of 2023 was $0.55 compared to $0.65 for the third quarter of 2022.

Phathom Pharmaceuticals Announces FDA Approval of Reformulated Vonoprazan Tablets for VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA® DUAL PAK® (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults

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월요일, 10월 30, 2023
Neoplasm, PDUFA, Food, Dysgeusia, Rash, Vitamin, Vonoprazan, Abdomen, Clarithromycin, Liver, Chills, Pain, Hypersensitivity, Infection, Allergy, Azithromycin, Rilpivirine, Diarrhea, Liver disease, Tablet, Medicine, Genetically modified bacteria, Drug, Safety, Patient, Chronic pain, DUAL, Catalent, History, Weight loss, Colchicine, GERD, Helicobacter pylori, Fever, Calcium channel, Common, PAS, Jaundice, CGA, Abdominal pain, FDA, Infectious mononucleosis, Headache, Aes, Skin, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Candidiasis, Erythromycin, Urine, Hypertension, Breast milk, Blood, AE, Pharmaceutical industry, Vaccine, Soft drink, Teahouse, Antibiotics, Medicinal plants, Dietary supplement, Birth control, Amoxicillin, Emtricitabine/rilpivirine/tenofovir

The full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK can be found here.

Key Points: 
  • The full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK can be found here.
  • VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) are co-packaged prescription medicines for the treatment of a Helicobacter pylori (H. pylori) bacterial infection in adults.
  • It is not known if VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are safe and effective in children.
  • Stop taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK if you are diagnosed with mononucleosis and call your doctor right away.

AMGEN PRESENTS NEW TARLATAMAB DATA IN SMALL CELL LUNG CANCER

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금요일, 10월 20, 2023
Survival, SCLC, ESMO, Progression-free survival, Trae tha Truth, Dysgeusia, MOS, Congress, European Society for Medical Oncology, Fever, Confidence interval, Amgen, Cytokine release syndrome, The New England Journal of Medicine, Oncology, ORR, AMGN, CRS, DLL3, Patient, Prognosis, Pharmaceutical industry, Research

THOUSAND OAKS, Calif., Oct. 20, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational delta-like ligand 3 (DLL3) targeting BiTE® (bispecific T-cell engager) molecule, in patients with advanced stage small cell lung cancer (SCLC) who had failed two or more prior lines of treatment. The data are being presented today at 3:20 PM CEST at a Proffered Paper session as a late-breaking oral presentation (LBA92) during the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, with publication in the New England Journal of Medicine.

Key Points: 
  • THOUSAND OAKS, Calif., Oct. 20, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational delta-like ligand 3 (DLL3) targeting BiTE® (bispecific T-cell engager) molecule, in patients with advanced stage small cell lung cancer (SCLC) who had failed two or more prior lines of treatment.
  • Of the patients who responded to treatment with tarlatamab at 10 mg dose, 58% experienced at least six months of response and 55% of responses were ongoing at data cutoff.
  • "Small cell lung cancer has represented one of the greatest challenges in cancer treatment, where there has been little progress against this deadly tumor type in decades," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "The tarlatamab results show the potential for this BiTE® molecule in a common solid tumor.