Hypertension

FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose

Retrieved on: 
Monday, April 8, 2024
General Health, FDA, Health, Pharmaceutical, Medical Supplies, Hypoventilation, Hypersensitivity, Nalmefene, Pulmonary edema, Caregiver, Safety, Tachycardia, Risk, New Drug Application, Patient, Ventricular tachycardia, Naloxone, Health care, Buprenorphine, Mortality, NDA, MD, Methadone, Ventricular fibrillation, Hypotension, Oxygen, LAAM, Recurrence, Allergy, Purdue University, Hypertension, Fentanyl, Pharmaceutical industry

Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.

Key Points: 
  • Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.
  • "Through this auto-injector FDA submission, our goal is to help expand the availability of nalmefene to the community alongside existing available options for healthcare professionals.
  • Priority review status means that FDA will expedite the review process to evaluate a drug that would significantly improve treatment of a serious condition.
  • Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

Study of NFL Alumni Cohort Finds Majority Suffer From Heart Disease Without Knowing It

Retrieved on: 
Sunday, April 7, 2024
Health, Sports, Football, Other Health, Other Science, Research, Science, Blood pressure, TTE, FACC, African Americans, Prevalence, Aortic stenosis, National Football League, Patient, Education, Ageing, Journal, History, MD, City, Male, American College, TAVR, EKG, AFL, Interventional cardiology, Alumni association, NFL, National Football League Alumni, Hypertension, Pharmaceutical industry

Edwards Lifesciences (NYSE: EW) announced the release of data from the HUDDLE study that examined the prevalence of heart disease and associated risk factors among members of the National Football League (NFL) Alumni Association and their families.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) announced the release of data from the HUDDLE study that examined the prevalence of heart disease and associated risk factors among members of the National Football League (NFL) Alumni Association and their families.
  • Results of the HUDDLE study indicated that the prevalence of hypertension in the 498 screened participants was 83.8%, though only about half (46.5%) self-reported a history of hypertension.
  • Conducted across eight U.S. cities in cooperation with NFL Alumni Health, a subsidiary of the NFL Alumni Association, HUDDLE was a cross sectional study of NFL alumni and their family members aged 50 years and above.
  • Study participants self-reported their medical histories and participated in heart health education and screenings that included blood pressure, electrocardiogram (EKG) and echocardiogram.

Alnylam Presents Positive Results from the KARDIA-2 Phase 2 Study of Zilebesiran Added to Standard of Care Antihypertensives in Patients with Inadequately Controlled Hypertension

Retrieved on: 
Sunday, April 7, 2024
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Managed Care, Health, Pharmaceutical, Science, Blood pressure, Medication, Indapamide, Risk, Patient, Month, SBP, ABPM, American College, Olmesartan, Injection, Safety, RNA interference, Therapy, AGT, ACC, Amlodipine, Cardiomyopathy, Hypertension, Pharmaceutical industry

Zilebesiran is an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension with the potential for biannual dosing.

Key Points: 
  • Zilebesiran is an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension with the potential for biannual dosing.
  • The results were presented today as a late-breaking clinical trial at the 2024 American College of Cardiology (ACC) Annual Scientific Session.
  • The Company previously announced positive topline results from the KARDIA-2 study in March 2024.
  • “Although many effective oral treatments are available, a large proportion of patients with hypertension are not managed to guideline-recommended targets.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Sequana Medical announces three month follow-up data from MOJAVE non-randomized cohort confirming dramatic improvement in diuretic response and virtual elimination of loop diuretics following DSR® therapy

Retrieved on: 
Monday, March 25, 2024
Cardiorenal syndrome, Congestion, Myocardial infarction, DSR, Brussels Stock Exchange, Liver disease, Partnership, RED, Patient, 2.0, Blood urea nitrogen, Cancer, Fluid, Heart, Heart failure, Furosemide, EGFR, Safety, DSMB, Overload, Hyponatremia, Hypertension, Pharmaceutical industry

These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.

Key Points: 
  • These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.
  • Unlike loop diuretics which, on average, have a negative impact on renal function and diuretic response, DSR has again demonstrated its potential to restore renal health and control of volume status.
  • Dramatic improvement in diuretic response and stable kidney function: During the four-week DSR treatment period, all three patients maintained euvolemia without the need of loop diuretics.
  • In January 2024, the independent DSMB approved the start of the randomized MOJAVE cohort following review of the safety data reported from the non-randomized cohort.

Three Patients with Invasive Fusarium Infection in Matinas BioPharma’s Oral MAT2203 Compassionate/Expanded Use Access Program Achieve Complete Clinical Response

Retrieved on: 
Friday, March 22, 2024
Nephrotoxicity, Urinary tract infection, Fungal infection, Culture, Ventilator-associated pneumonia, Burns, Internal medicine, Amphotericin B, Emphysema, Azole, Coronary artery disease, Debridement, Carcinoma, Risk, Hyperlipidemia, Patient, Lung, LNC, Fusarium, Female, Malignancy, University, Doctor of Philosophy, MD, Aspergillosis, Echinocandin, Fever, Immune system, Division, Hypertension, Voriconazole, Physician, Infection, Pharmaceutical industry

The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.

Key Points: 
  • The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.
  • She was transitioned to oral MAT2203 for two weeks, which led to clinical resolution of her fungal infection.
  • She began to show clinical improvement following two weeks of oral MAT2203 treatment and her skin wounds completely healed following six months of MAT2203 treatment.
  • “MAT2203 continues to demonstrate its potential to effectively treat invasive fungal infections and help patients achieve complete clinical resolution.

Mineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, American Heart Association, Administration, Conference call, Conference, Target, Obesity, Prevalence, CKD, Part, Patient, SGLT2, G&A, Pivotal, Insurance, Investment, Research and development, AHA, Therapy, EGFR, Senior management, Safety, Chronic kidney disease, Hypertension, Leptin, BMI, Aldosterone, Pharmaceutical industry

RADNOR, Pa., March 21, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update.

Key Points: 
  • R&D expenses for the quarter ended December 31, 2023 were $23.7 million, compared to $7.8 million for the quarter ended December 31, 2022.
  • G&A expenses were $4.0 million for the quarter ended December 31, 2023, compared to $2.2 million for the quarter ended December 31, 2022.
  • Total other income, net was $3.3 million for the quarter ended December 31, 2023, compared to $0.9 million for the quarter ended December 31, 2022.
  • Net loss was $24.4 million for the quarter ended December 31, 2023, compared to $9.1 million for the quarter ended December 31, 2022.

Checkpoint Therapeutics Announces Appointment of Accomplished Life Sciences Executive Amit Sharma, M.D. to Board of Directors

Retrieved on: 
Monday, March 18, 2024
Internal medicine, Circulatory system, Certification, CKPT, FASN, Biotechnology, FACP, Research, University, Nephrology, Society, Marketing, Hematology, Alexion, Bayer, Health, Hypertension, Pharmaceutical industry

WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately.

Key Points: 
  • WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately.
  • Prior to joining Alexion, he served as Vice President of Medical Affairs for the Cardiovascular and Renal Division of Bayer Pharmaceuticals.
  • “We are pleased to welcome Dr. Sharma to our Board of Directors,” said James F. Oliviero, President and Chief Executive Officer of Checkpoint.
  • “He is a highly accomplished life sciences executive, with leadership experience in many facets of both patient care and the research, development, approval and commercialization of pharmaceutical products.

FDA’s Approval of Breakthrough NASH Treatment Opens Door for a Long-Neglected Patient Population

Retrieved on: 
Thursday, March 14, 2024
Organization, Obesity, Cirrhosis, Exercise, Cardiology, Partnership, F2, Risk, Patient, Fatty liver disease, Hope, Diet, NASH, Language, Liver disease, Liver cancer, Hypertension, FDA, Drug development, JD, Food, GLI

Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.

Key Points: 
  • Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.
  • This breakthrough follows years of NASH patient-led, multi-stakeholder advocacy and partnership with researchers in both drug and diagnostic development.
  • “Today’s announcement represents the culmination of the work of the united NASH community.
  • It is particularly satisfying that we can mark Women’s History Month with a breakthrough from a female-founded company.