Simvastatin

23andMe Reports Second Quarter Fiscal 2024 Financial Results

Retrieved on: 
Wednesday, November 8, 2023
FDA, Research, African Americans, 23andMe, PGS, Health, Science, CORE (research service), Society for Immunotherapy of Cancer, Behavior, BRCA1, Consumer, Genetics, EBITDA, Workforce, Health Action International, Premium, Bangladesh Technical Education Board, Inflammation, BRCA2, DNA, Advertising, Pharmacokinetics, Consumer service, SITC, Science (journal), Immunotherapy, Database, Growth, Marketing, Webcast, GSK, GSK plc, Blood, Society, African, Total, Table, Pharmacogenomics, Harvard University, Lijun International Pharmaceutical (Holding) Co. Ltd., SAN, Pharmaceutical industry, Mobile phone, CD200R1, Simvastatin, Therapy

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME), a leading human genetics and biopharmaceutical company, reported its financial results for the second quarter of fiscal year 2024 (FY24), which ended September 30, 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME), a leading human genetics and biopharmaceutical company, reported its financial results for the second quarter of fiscal year 2024 (FY24), which ended September 30, 2023.
  • Members of Total Health will also receive all the reports and features offered in our existing 23andMe+ Premium Membership.
  • Full year Adjusted EBITDA deficit is reaffirmed to be in the range of $180 to $160 million for fiscal year 2024.
  • 23andMe will host a conference call at 4:30 p.m. Eastern Time today, November 8, 2023, to discuss the financial results for Q2 FY2024 and report on business progress.

Global Platform Study Presents Results to Guide Care of Severely Ill Patients With COVID-19 Using Routinely Available Drugs – Simvastatin and Vitamin C

Retrieved on: 
Wednesday, October 25, 2023
Science, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Hospitals, Clinical Trials, WHO, Urinary tract infection, Survival, FRCP, Patient, Vitamin C, Simvastatin, Royal Victoria Hospital, Montreal, Bronchopneumonia, MPH, Global Coalition Against Pneumonia, Oregon Health & Science University, University, Respiratory tract infection, JAMA, Professor, Vitamin, Multimedia, Queen's University Belfast, University of Pittsburgh School of Medicine, Learning, Critical Care Medicine (journal), COVID, Clinical trial, Intensive care unit, Hospital, NEJM, Probability, Pittsburgh, European Society of Clinical Microbiology and Infectious Diseases, Wilfrid Sellars, SUNY Downstate Health Sciences University, Hospice and palliative medicine, Intensive care medicine, Royal Victoria Hospital, UPMC, Consultant, Ohio State University Wexner Medical Center, Pharmaceutical industry, Dietary supplement, MD

Vitamin C is widely available around the world and was used in some settings for the treatment of COVID-19.

Key Points: 
  • Vitamin C is widely available around the world and was used in some settings for the treatment of COVID-19.
  • Through harmonizing two clinical trials – REMAP-CAP and LOVIT-COVID – over 2500 patients in 20 countries took part, including both critically ill and non-critically ill patients with COVID-19 in hospital.
  • It was shown that high dose vitamin C did not improve outcomes for patients.
  • Intravenous Vitamin C for Patients Hospitalized with COVID-19: Two Harmonized Randomized Clinical Trials.

Homozygous Familial Hypercholesterolemia in the 7MM, 2023-2032: Epidemiology, Treatment Trends, Pipeline Activities, Expert Insights - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 29, 2023
Pharmaceutical, Health, Cardiology, Other Health, Prevalence, Rosuvastatin, Simvastatin, Epidemiology, FH, MTP, Atorvastatin, ANGPTL3, Patient, LDL, PCSK9, Improved, Population growth, Pharmaceutical industry

The "Homozygous Familial Hypercholesterolemia: Market Insights, Epidemiology and Forecast to 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Homozygous Familial Hypercholesterolemia: Market Insights, Epidemiology and Forecast to 2032" report has been added to ResearchAndMarkets.com's offering.
  • The diagnosed prevalence of homozygous familial hypercholesterolemia (FH) has been on the rise in the US due to increased awareness and population growth.
  • Updated international diagnostic and clinical guidelines provide evidence-based therapeutic approaches and screening strategies for early identification of FH and homozygous FH.
  • The report offers a comprehensive understanding of homozygous FH epidemiology, treatment trends, pipeline activities, and expert insights.

Esperion Presents Two CLEAR Outcomes Study Late-Breakers at European Society of Cardiology Congress 2023

Retrieved on: 
Saturday, August 26, 2023
CV, Shoulder, Diabetes, Life, Splenic infarction, Spasm, Fetus, Lactation, Pregnancy, European Society of Cardiology, Bempedoic acid, Doctor of Philosophy, Pain, Congress, Prediabetes, Patient, Risk, Disease, Gout, Diet, MBBS, Ezetimibe, Drug, Simvastatin, Cardiovascular disease, Pravastatin, Back pain, Fellow of the Academy of Medical Sciences, ESPR, Tablet, ESC, Safety, Rotator cuff, Atrial fibrillation, CVD, Abdominal pain, Uric acid, Anemia, Mortality, Imperial College London, Achilles tendon, Glycated hemoglobin, Bronchitis, Tendon rupture, Monash University, ATP, Rupture, Kidney, NEJM, CLEAR, Moyamoya disease, Upper respiratory tract infection, Health, Dietary supplement, Pharmaceutical industry, MD, Esperies, Hyperuricemia

ANN ARBOR, Mich., Aug. 26, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from two oral presentations at the Late-Breaking Science Session entitled, “Clinical trial updates on prevention and lipid lowering” at the European Society of Cardiology (ESC) 2023 Congress, taking place August 25-28, 2023, in Amsterdam, Netherlands.

Key Points: 
  • “We are pleased to share additional results from our landmark CLEAR Outcomes study in late-breaker presentations at ESC 2023,” said Sheldon Koenig, President and CEO of Esperion.
  • Of the 13,970 patients included in CLEAR Outcomes, 45.6% had diabetes, 41.5% were pre-diabetic, and 12.9% had normoglycemia.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

23andMe Releases New FDA-Cleared Genetic Report on Simvastatin, a Commonly Prescribed Statin

Retrieved on: 
Thursday, July 20, 2023
Lijun International Pharmaceutical (Holding) Co. Ltd., 23andMe, Genomic Health, Diet, Genetics, Stroke, Simvastatin, Pharmacogenomics, Cholesterol, Myopathy, Splenic infarction, Weakness, Prescription, Myalgia, Risk, Blood, SLCO1B1, Liver, FDA, Dietary supplement, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., July 20, 2023 (GLOBE NEWSWIRE) --  23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, released a new Simvastatin Medication Insight report as part of its 23andMe+ membership service that reports on a person's likelihood of experiencing side effects from this commonly prescribed statin drug.

Key Points: 
  • Simvastatin is a commonly prescribed statin drug used to lower cholesterol in the blood and reduce the risk of heart attacks, strokes, or other heart problems.
  • “But we have also known for some time that genetic differences play a major role in the effectiveness of many medicines.
  • The insight report provides clear information about whether an individual has an increased chance of experiencing side effects.
  • About 8 million people in the US were prescribed the statin simvastatin in 2020, amounting to about 36 million prescriptions, making it among the most prescribed medications in the United States.

Endo Launches First Generic Version of Noxafil® (posaconazole) Injection

Retrieved on: 
Thursday, June 29, 2023
CLL, Hypersensitivity, Lymphocytosis, Pimozide, Arrhythmia, Tacrolimus, Chronic lymphocytic leukemia, SLL, Liver disease, Simvastatin, Magnesium, Atorvastatin, Antifungal, Person, QT, Sirolimus, QT interval, Ergot, Alkaline phosphatase, Plasma, Kidney, Lovastatin, Ergotism, Patient, Azole, Risk, Electrolyte, Ergotamine, Dihydroergotamine, Tumor lysis syndrome, Ciclosporin, ALT, Quinidine, Rhabdomyolysis, Potassium, AST, Venetoclax, Pharmaceutical industry, Posaconazole, CYP3A4

Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.

Key Points: 
  • Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
  • Posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism.
  • Reserve azole antifungals, including posaconazole injection, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
  • Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.

Endo Launches First Generic Version of Noxafil® (posaconazole) Injection

Retrieved on: 
Thursday, June 29, 2023
CLL, Hypersensitivity, Lymphocytosis, Pimozide, Arrhythmia, Tacrolimus, Chronic lymphocytic leukemia, SLL, Liver disease, Simvastatin, Magnesium, Atorvastatin, Antifungal, Person, QT, Sirolimus, QT interval, Ergot, Alkaline phosphatase, Plasma, Kidney, Lovastatin, Ergotism, Patient, Azole, Risk, Electrolyte, Ergotamine, Dihydroergotamine, Tumor lysis syndrome, Ciclosporin, ALT, Quinidine, Rhabdomyolysis, Potassium, AST, Venetoclax, Pharmaceutical industry, Posaconazole, CYP3A4

Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.

Key Points: 
  • Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
  • Posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism.
  • Reserve azole antifungals, including posaconazole injection, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
  • Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.

Esperion Presents Results from New Analysis on Cardiovascular Benefits with Bempedoic Acid Treatment at ENDO 2023

Retrieved on: 
Thursday, June 15, 2023
ENDO, MVE, CV, Shoulder, Spasm, Fetus, Lactation, Pregnancy, Bempedoic acid, CTT, Pain, Patient, Analysis, Risk, Concentration ratio, The New England Journal of Medicine, Disease, Gout, Diet, Myocardial infarction, Ezetimibe, ANN, Drug, Simvastatin, Pravastatin, Back pain, ESPR, Tablet, Death, Safety, Rotator cuff, Atrial fibrillation, Stroke, CVD, Abdominal pain, Uric acid, Molina Healthcare, Anemia, Mortality, IL, Achilles tendon, Bronchitis, Tendon rupture, ATP, Rupture, Kidney, CLEAR, Moyamoya disease, Upper respiratory tract infection, Health, Pharmaceutical industry, Dietary supplement, Esperies, Hyperuricemia

“We are pleased to present this analysis at ENDO 2023, demonstrating that the cardiovascular risk reduction benefit of bempedoic acid treatment is comparable to that of statins based on an analysis of per unit decrease in LDL-C,” said Sheldon Koenig, President and CEO of Esperion.

Key Points: 
  • “We are pleased to present this analysis at ENDO 2023, demonstrating that the cardiovascular risk reduction benefit of bempedoic acid treatment is comparable to that of statins based on an analysis of per unit decrease in LDL-C,” said Sheldon Koenig, President and CEO of Esperion.
  • The beneficial effect of bempedoic acid on MVE reduction generally improved over time, similar to what was observed in statin CVOTs.
  • Limitations of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

Retrieved on: 
Tuesday, June 6, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, MSD, Cytomegalovirus, Neutropenia, Male, Pimozide, Aciclovir, IV, AE, Culture, Alkaloid, Simvastatin, Aes, Myopathy, Valganciclovir, MRK, HSCT, Immunotherapy, Merck & Co., Hypertension, Incidence, Ergotism, Diarrhea, Drug, Patient, Leukopenia, Blood, CMV, Kidney, Ciclosporin, ALT, Transplant, Rhabdomyolysis, AST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, NYSE, Food, Safety, Disease, Medical device, Vaccine, Pharmaceutical industry, Merck

PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Key Points: 
  • PREVYMIS is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
  • Increased pimozide concentrations due to concomitant administration of PREVYMIS may lead to QT prolongation and torsades de pointes.
  • Study drug was initiated between Day 0 and Day 7 post-kidney transplant and continued through Week 28 (~200 days) post-transplant.
  • The most common primary reasons for transplant were congenital cystic kidney disease (17%), hypertension (16%), and diabetes/diabetic nephropathy (14%).

Esperion Retains Gibson Dunn to Secure $300 Million Payment From DSE; Will Announce First Quarter Financial Results Tuesday, May 9

Retrieved on: 
Thursday, May 4, 2023
DSE, Rotator cuff, Pressure, Gout, Pregnancy, Bronchitis, Diet, Shoulder, ANN, Spasm, Tendon rupture, Drug, Atrial fibrillation, Simvastatin, Lactation, Fetus, ATP, Rupture, Kidney, Pravastatin, CVD, Abdominal pain, Complaint, Uric acid, Pain, CLEAR, Back pain, ESPR, Patient, Risk, Anemia, Disease, Mortality, Moyamoya disease, Upper respiratory tract infection, Health, Achilles tendon, Safety, Property management, Pharmaceutical industry, Dietary supplement, Hyperuricemia, Bempedoic acid, Esperies

The complaint seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to Esperion upon regulatory approval.

Key Points: 
  • The complaint seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to Esperion upon regulatory approval.
  • “This amended complaint, filed by Gibson Dunn and supported by new evidence, makes clear that we are entitled to the $300 million milestone payment from DSE upon regulatory approval.
  • We will not acquiesce to DSE’s commercially dishonest tactics,” says Esperion President and Chief Executive Officer Sheldon Koenig.
  • “We are working diligently to resolve this dispute as we continue to commercialize bempedoic acid in Europe and around the world.