Digoxin

Urovant Sciences® Presents Interim Data from Phase 2a Study of Investigational Novel Gene Therapy, URO-902, Supporting Safety, Tolerability, and Efficacy Endpoints at 2022 American Urological Association Meeting

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금요일, 5월 13, 2022
Health, Genetics, Clinical Trials, General Health, Pharmaceutical, Biotechnology, American Urological Association, Urination, Sex, Medicine, Urinary urgency, Urine, Sore throat, Overactive bladder, Vitamin, Neurogenic bladder dysfunction, Female, Nasal congestion, Urinary incontinence, Headache, Twitter, Science, Oakland University, Burden, Allergy, Nausea, Professor, Journal, Liver, Breast milk, Woman, Medical school, Beaumont, Vats, The Journal of Urology, Man, Urinary tract infection, Trial of the century, Diarrhea, NYSE, Department, Urinary retention, Catheter, Kopp, Digoxin, Doctor of Philosophy, I, Micturition syncope, Beaumont Hospital, Patient, OAB, Adult, FDA, Public health, LinkedIn, MD, Kidney, Upper respiratory tract infection, Population, Injection, Nocturia, Cystoscopy, Gesellschaft mit beschränkter Haftung, Safety, Pharmaceutical industry, Dietary supplement, Urology, Sexton

This was a prespecified, 12-week interim analysis of a 48-week multicenter, randomized, double-blind, placebo-controlled, dose-escalation study ( NCT04211831 ).

Key Points: 
  • This was a prespecified, 12-week interim analysis of a 48-week multicenter, randomized, double-blind, placebo-controlled, dose-escalation study ( NCT04211831 ).
  • Treatment-emergent adverse events occurred in 45.5% of patients receiving URO-902 24 mg, 46.2% receiving 48 mg, and 50.0% receiving placebo.
  • We are encouraged by these promising interim safety and efficacy findings for URO-902, said Sef Kurstjens, MD, PhD, Executive Vice President and Chief Medical Officer of Urovant Sciences.
  • UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

Urovant Sciences Announces Publication of EMPOWUR Trial Subgroup Analysis Showing Similar Efficacy for GEMTESA® in Dry and Wet Overactive Bladder Populations

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화요일, 4월 19, 2022
Health, Pharmaceutical, Overactive bladder, Urinary urgency, Urination, Woman, Population, Urinary tract infection, Drug, Patient, Sore throat, LinkedIn, Vibegron, Nocturia, Allergy, Urinary incontinence, Journal, FDA, Upper respiratory tract infection, Diarrhea, Breast milk, Adult, Paced Auditory Serial Addition Test, Hypertension, Incidence, Digoxin, The Journal of Urology, Canadian International Council, Liver, Man, Senior, Nausea, Vitamin, International Journal of Clinical Practice, Medicine, Twitter, MD, Urinary retention, Safety, OAB, Kidney, Nasal congestion, Common, Gesellschaft mit beschränkter Haftung, Urine, Headache, NYSE, Â, Science, Pharmaceutical industry, Copper, Dietary supplement, Fine chemical, Urology

The peer-reviewed paper is entitled, Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.

Key Points: 
  • The peer-reviewed paper is entitled, Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.
  • OAB is characterized by urgency and frequency with (OAB wet) or without (OAB dry) urge urinary incontinence (UUI).
  • The post-hoc analysis was developed to compare efficacy of vibegron vs. placebo in OAB wet and dry populations.
  • UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

Urovant Sciences to Present Interim Data from Phase 2a Study of Potential Novel Gene Therapy, URO-902, and New Analyses of Data from Phase 3 EMPOWUR Extension Trial of GEMTESA® (vibegron) 75 mg at 2022 American Urological Association Annual Meeting

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수요일, 4월 13, 2022
Health, Genetics, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Patient, Vitamin, Breast milk, Overactive bladder, Kidney, Urinary urgency, Urination, Medicine, Public health, Woman, Cystoscopy, I, Urinary tract infection, Twitter, Adult, Nasal congestion, Incidence, Neurogenic bladder dysfunction, Urinary retention, Sore throat, Burden, Digoxin, Kopp, LinkedIn, Injection, Vats, Urine, Nocturia, Allergy, Sex, Female, Liver, Urinary incontinence, Man, Headache, NYSE, Safety, FDA, OAB, Diarrhea, Nausea, Upper respiratory tract infection, Pharmaceutical industry, Medical imaging, Dietary supplement, Urology, Sexton

URO-902 has the potential to be the first gene therapy for patients with OAB.

Key Points: 
  • URO-902 has the potential to be the first gene therapy for patients with OAB.
  • If approved, this innovative treatment has the potential to address an unmet need for patients who have failed oral pharmacologic therapies.
  • Secondary endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total urinary incontinence.
  • Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions.

Urovant Sciences Announces Appointment of Sef Kurstjens as Executive Vice President and Chief Medical Officer

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월요일, 4월 4, 2022
Health, Pharmaceutical, LinkedIn, Headache, Paced Auditory Serial Addition Test, Upper respiratory tract infection, Nasal congestion, United Kingdom, Diarrhea, University of the Witwatersrand, CMO, NYSE, Adult, Overactive bladder, Digoxin, Kidney, Allergy, Urinary incontinence, Urinary retention, Urinary tract infection, Medicine, Health, Pediatrics, Man, Nausea, CEO, Senior, Breast milk, Science, Lead, Allergan, Inc., Industry, Pfizer, Vitamin, Sore throat, Twitter, OAB, Drug, Liver, FDA, University, Patient, Management, Pharmaceutical industry, Fine chemical, Dietary supplement, Urology, VideoRay UROVs, Health, Pharmaceutical

Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced Sef Kurstjens, M.D., PhD., has been appointed Executive Vice President and Chief Medical Officer (CMO).

Key Points: 
  • Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced Sef Kurstjens, M.D., PhD., has been appointed Executive Vice President and Chief Medical Officer (CMO).
  • I am delighted to welcome Sef Kurstjens to the executive leadership team to lead our clinical and medical affairs activities.
  • His appointment reflects his deep commitment to Urovant and improving the lives of people with urological conditions, said James Robinson, president and CEO of Urovant Sciences.
  • Dr. Kurstjens appointment comes as we work to expand commercial access to GEMTESA and advance our product pipeline.

Cytokinetics Announces Results From METEORIC-HF and Additional Data From GALACTIC-HF Presented at the American College of Cardiology 71st Annual Scientific Session

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일요일, 4월 3, 2022
Hospital, Kidney, Exercise, Risk, Heart failure, University, HF, CV, Heart, Yale School of Medicine, NYHA, Death, Health, Blood, University of Glasgow, Digoxin, RRR, NNT, Patient, Evaluation, MPH, Standard of care, Associate, New York Heart Association Functional Classification, Cardiology, ARR, Center, Systole, Outcomes research, Duke University School of Medicine, American College, Institute, GLOBE, Cytokinetics, Medicine, LVEF, NDA, EF, Contractility, Prescription Drug User Fee Act, Atrial fibrillation, PDUFA, CPET, SAN, Research and development, FDA, Prognosis, Functional, Pharmaceutical industry, Medical device

SOUTH SAN FRANCISCO, Calif., April 03, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the full results from METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF), were presented by Michael Felker, M.D., Professor of Medicine, Duke Clinical Research Institute, at the American College of Cardiology 71st Annual Scientific Session (ACC.22). Additional data from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were also presented including a healthcare resource utilization analysis and an analysis of the effect of treatment with omecamtiv mecarbil in hospitalized patients compared to outpatients.

Key Points: 
  • After 20 weeks of treatment, there was no change in pVO2 in patients treated with omecamtiv mecarbil versus placebo.
  • Adverse events, including major cardiac events, were similar between the treatment arms, even with patients reaching peak exercise.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Urovant Sciences Announces Publication of New Review of Efficacy and Safety Data for GEMTESA® (vibegron) 75 mg in Overactive Bladder Patients in the Journal Therapeutics and Clinical Risk Management

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화요일, 3월 22, 2022
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Urine, List of Dove Medical Press academic journals, Therapy, LinkedIn, Headache, Blood pressure, Upper respiratory tract infection, Hypertension, Nasal congestion, Vibegron, Diarrhea, NYSE, Overactive bladder, Digoxin, Adult, Urinary tract infection, Allergy, Urinary incontinence, Doctor of Philosophy, Kidney, Urination, Urinary retention, Woman, Incidence, Urinary urgency, Man, Medicine, Nausea, Nocturia, Breast milk, Science, MD, Safety, Review, Vitamin, Sore throat, Twitter, OAB, Sumitomo Dainippon Pharma, Heart rate, Common, Liver, AES, FDA, Patient, Dietary supplement, Pharmaceutical industry, Copper, Fine chemical, Urology, THE EMPOWUR TRIAL, THE 40-WEEK EMPOWUR EXTENSION

Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the publication of a new review of data on GEMTESA (vibegron) 75 mg in the peer-reviewed journal, Therapeutics and Clinical Risk Management ( https://bit.ly/Vibegron ).

Key Points: 
  • Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the publication of a new review of data on GEMTESA (vibegron) 75 mg in the peer-reviewed journal, Therapeutics and Clinical Risk Management ( https://bit.ly/Vibegron ).
  • Titled, An evaluation of the efficacy and safety of vibegron in the treatment of overactive bladder, the paper reviews published data from studies conducted over the past three years.
  • The 40-week EMPOWUR extension study evaluated safety in patients receiving GEMTESA for 52 weeks.
  • In EMPOWUR, the most frequently occurring treatment-emergent AEs (TEAEs) with incidence greater for vibegron than placebo were headache and nasopharyngitis.

Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902

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월요일, 3월 7, 2022
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Sumitomo Dainippon Pharma, Upper respiratory tract infection, Patient, Adult, Medicine, Breast milk, Twitter, Sore throat, Doctor of Philosophy, Safety, Liver, LinkedIn, FDA, Kidney, Science, NYSE, Urinary incontinence, Headache, Nausea, Overactive bladder, American Urological Association, Urinary retention, Man, Vitamin, Allergy, Oakland University William Beaumont School of Medicine, Oakland University, Micturition syncope, Injection, Diarrhea, Beaumont Hospital, Female, Nasal congestion, MD, OAB, Digoxin, Urinary tract infection, Beaumont, Pharmaceutical industry, Fine chemical, Dietary supplement, Urology, the Phase 2a Study, URO-902, the Phase 2a Study, URO-902, THE PHASE 2A STUDY, URO-902

URO-902 has the potential to be the first gene therapy for patients with OAB.

Key Points: 
  • URO-902 has the potential to be the first gene therapy for patients with OAB.
  • The company plans to present the topline results of the study at the American Urological Association annual meeting being held May 13-16, 2022 in New Orleans, LA.
  • Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in Urology.
  • The Companys second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.

BioCryst to Present New ORLADEYO® (berotralstat) Data at 2022 American Academy of Allergy, Asthma & Immunology Annual Meeting

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화요일, 2월 1, 2022
Safety, Food, Patient, HAE, BCRP, Ciclosporin, PARK, Poster, American Academy, Quality of life, BioCryst Pharmaceuticals, CYP3A4, Plasma kallikrein, American Academy of Allergy, Asthma, and Immunology, Abdominal pain, AAAAI, Adult, Back pain, Hereditary angioedema, Rifampicin, Berotralstat, Diarrhea, Gastroesophageal reflux disease, Plasma, GLOBE, CYP2D6, Digoxin, Liver, RESEARCH, Kallikrein, 2021 Essex County Council election, Nasdaq, Vomiting, Pharmaceutical industry, Dentistry, QT

We look forward to presenting our findings at the AAAAI annual meeting later this month.

Key Points: 
  • We look forward to presenting our findings at the AAAAI annual meeting later this month.
  • One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
  • ORLADEYO (berotralstat)is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
  • The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established.

BioCryst Announces Preliminary Full Year 2021 ORLADEYO® (berotralstat) Net Revenue and Provides Full Year 2022 ORLADEYO Net Revenue and Peak Sales Guidance

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월요일, 1월 10, 2022
Plasma kallikrein, Diarrhea, Safety, Back pain, POC, Ciclosporin, BioCryst Pharmaceuticals, Hereditary angioedema, CYP3A4, PMN, Investor, Berotralstat, Patient, PNH, Physician, Vomiting, IgA nephropathy, Conference, Adult, Liver, Kallikrein, Plasma, PARK, Rifampicin, Immunoglobulin A, Abdominal pain, BCRP, RESEARCH, Company, Nasdaq, Paroxysmal nocturnal hemoglobinuria, Digoxin, CYP2D6, GLOBE, Gastroesophageal reflux disease, HAE, Food, Pharmaceutical industry, Dentistry, QT

RESEARCH TRIANGLE PARK, N.C., Jan. 10, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced preliminary, unaudited ORLADEYO® (berotralstat) revenue for the fourth quarter and full year 2021 and provided new guidance for full year 2022 ORLADEYO net revenue and expected peak ORLADEYO sales.

Key Points: 
  • Preliminary, unaudited ORLADEYO net revenue in Q4 2021 was $45.6 million.
  • Preliminary, unaudited ORLADEYO net revenue for full year 2021 (FY 2021) was $122 million.
  • Approximately 70 percent of patients starting ORLADEYO, including those switching from injectable prophylaxis, remain on ORLADEYO in the first year.
  • The number of new physicians prescribing ORLADEYO in Q4 2021 was similar to the number added in Q3 2021.

Royalty Pharma Acquires Additional Royalty Interests in BCX9930 and ORLADEYO from BioCryst Pharmaceuticals

Patient, HAE, Sidley Austin, Safety, BCRP, PNH, Digoxin, Plasma kallikrein, PARK, BioCryst Pharmaceuticals, Kallikrein, Plasma, Partnership, Berotralstat, RESEARCH, Armin Maiwald, Abdominal pain, Back pain, Nasdaq, Legorreta, Liver, GLOBE, Diarrhea, Adult, CYP3A4, Ciclosporin, Rifampicin, Vomiting, Hereditary angioedema, Royalty Pharma, Food, CYP2D6, Gastroesophageal reflux disease, Degenerative disease, OMERS, Pharmaceutical industry, Music, Dentistry

These royalties are additional to the royalties purchased by Royalty Pharma in December 2020.

Key Points: 
  • These royalties are additional to the royalties purchased by Royalty Pharma in December 2020.
  • The first royalty payment from BioCryst to OMERS will occur based on royalties from direct annual net sales of ORLADEYO in the fourth quarter of 2023.
  • We are excited to expand our partnership with BioCryst to continue to support their growth journey, said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma.
  • Almost a year into its launch, BioCryst has established ORLADEYO as a leading HAE prophylactic therapy.