Remdesivir

AHF Hammers Gilead Over Continued Profiteering

Retrieved on: 
Wednesday, February 7, 2024
Environmental, Social and Governance (ESG), COVID-19, Socially Responsible Investing, Healthcare Reform, Pharmaceutical, Professional Services, Philanthropy, Advocacy Group Opinion, Infectious Diseases, Public Policy, Government, LGBTQ+, Foundation, Biotechnology, AIDS, Consumer, Health, HIV, AHF, Patient, Safety, Remdesivir, AIDS Healthcare Foundation, Assault, Hepatitis, Gilead Sciences, Pharmaceutical industry

AIDS Healthcare Foundation (AHF) continued its assault on Gilead Sciences in its ongoing advocacy campaign against the Bay Area drug maker over its voracious greed, patent manipulation, and obscene price hikes.

Key Points: 
  • AIDS Healthcare Foundation (AHF) continued its assault on Gilead Sciences in its ongoing advocacy campaign against the Bay Area drug maker over its voracious greed, patent manipulation, and obscene price hikes.
  • “Gilead continues to place profit above all else at the expense of patients’ access to its lifesaving drugs, including its latest and safest drug formulations,” says Michael Weinstein, AHF president and cofounder.
  • “From suppressing a safer formulation of one of its key HIV drugs to price gouging on its Hepatitis C medications, Gilead remains a company in search of a moral compass.
  • To learn more about AHF, visit us online at AIDShealth.org , find us on Facebook , follow us on Instagram , Twitter , and TikTok , and subscribe to our AHFter Hours podcast.

Gilead Sciences Announces Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Pharmaceutical, AIDS, Oncology, General Health, Health, Infectious Diseases, Hospitals, BIRCH, Food, Pembrolizumab, B-cell lymphoma, Impact of the COVID-19 pandemic on hospitals, EPS, COVID-19, Tax rate, ETR, CAPELLA, Cohort study, Infection, Acute lymphoblastic leukemia, American Association for the Study of Liver Diseases, SARS-CoV-2, Earnings per share, HIV, GAAP, HCV, Safety, Patient, Food and Drug Administration, European Commission, Conference, Obeldesivir, Research, Growth, European, Lung cancer, Total, HDV, PD-L1, Research and development, Incidence, Hepatology, Axicabtagene ciloleucel, Omicron, Liver, Lung, Risk, Science, FTC, Table, Liver disease, HBV, Pharmaceutical industry, Video game, Fine chemical, Security (finance), Virology, Sacituzumab govitecan, Remdesivir

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.
  • During the third quarter of 2023, Gilead generated $1.8 billion in operating cash flow.
  • During the third quarter of 2023, Gilead repaid $2.3 billion of debt, paid dividends of $953 million and repurchased $300 million of common stock.
  • Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.

Gilead to Present Latest Innovative Virology Data on Current and Potentially Transformative Therapies Across HIV and COVID-19 at IDWeek 2023

Retrieved on: 
Tuesday, October 3, 2023
Biotechnology, FDA, AIDS, Health, Pharmaceutical, Research, Infectious Diseases, Hospitals, Science, COVID-19, Clinical Trials, XBF, Abstract, Gilead Sciences, Omicron, Senior, HIV, Obeldesivir, Virology, SARS-CoV-2, Safety, Pre-exposure prophylaxis, Lenacapavir, HIV capsid inhibition, Tablet, Drug resistance, MD, Patient, Boxed warning, Liver, CAPELLA, Pharmaceutical industry, Bictegravir/emtricitabine/tenofovir alafenamide, Remdesivir

These latest data demonstrate the company’s ongoing efforts to address the unmet medical needs of people and communities affected by HIV and COVID-19.

Key Points: 
  • These latest data demonstrate the company’s ongoing efforts to address the unmet medical needs of people and communities affected by HIV and COVID-19.
  • Gilead will be presenting 16 abstracts, including real-world evidence, as the company continues to pursue the next wave of scientific discovery in virology.
  • “At IDWeek 2023, we look forward to sharing our latest data with the broader community and discussing potential implications for the treatment of COVID-19 among some of the most vulnerable populations.
  • At IDWeek 2023, Gilead will present data that reinforces the ongoing role Veklury® (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19.

CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir) to Treat COVID-19 in People With Hepatic Impairment

Retrieved on: 
Tuesday, September 19, 2023
Health, Infectious Diseases, Hospitals, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Gilead Sciences, Liver disease, Safety, European Medicines Agency, Committee for Medicinal Products for Human Use, Pharmacokinetics, Virus, Emergent virus, Liver, European Commission, Committee, EMA, Hepatitis, Patient, Risk, European, Disease, Science, Mortality, EC, Infection, CHMP, Vaccine, Pharmaceutical industry, EU, MD, Remdesivir

Europe has the highest burden of liver disease in the world and cases are expected to grow across many countries.

Key Points: 
  • Europe has the highest burden of liver disease in the world and cases are expected to grow across many countries.
  • Safety data in people with severe hepatic impairment are limited and there are few treatment options that are safe and effective.
  • This positive opinion was based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment (GS-US-540-9014).
  • “Expanding the use of Veklury to those with hepatic impairment will help more people gain access to treatment for COVID-19.”
    This positive opinion follows recent approvals in the U.S. and the EU which extended the approval of Veklury to treat COVID-19 in people with renal and hepatic impairment.

FDA Approves Veklury® (Remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment

Retrieved on: 
Thursday, August 24, 2023
Biotechnology, Pharmaceutical, Health, FDA, COVID-19, Infectious Diseases, Hospitals, Clinical Trials, Gilead Sciences, Senior, Liver disease, Alanine transaminase, Pharmacokinetics, Research, Mount Sinai, Liver, Dialysis, Kidney, Shanda, MD, Patient, Hepatology, Risk, Division, Icahn School of Medicine at Mount Sinai, Disease, ALT, Science, Mortality, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, European Commission, Safety, Hepatitis, Pharmaceutical industry, Remdesivir

The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but the pharmacokinetics of Veklury had not previously been evaluated in patients with hepatic impairment.

Key Points: 
  • The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but the pharmacokinetics of Veklury had not previously been evaluated in patients with hepatic impairment.
  • This latest approval is based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment (GS-US-540-9014).
  • Based upon these results, the label has been updated to reflect that no dose adjustment is required across all stages of liver disease.
  • Furthermore, people with liver disease represent a population that is vulnerable to COVID-19 and are at increased risk of morbidity and mortality.

Vizient: Expansion of Specialty Drugs Driving a 3.42% Projected Increase in Hospital Pharmacy Spend

Retrieved on: 
Tuesday, August 1, 2023
Medical Supplies, Medical Devices, Health, Hospitals, Practice Management, Pharmaceutical, Rituximab, Bevacizumab, Migraine, Drug development, Trastuzumab, Ustekinumab, Adalimumab, Cancer, Remdesivir, CGRP, Multimedia, Pharmacy, Multiple sclerosis, Outlook, Acquisition, COVID-19, Patient, Tebentafusp, Teclistamab, FDA, News, Calcitonin, Pharmaceutical industry, Generic drug, Denosumab, Vizient, Inc., Ocrelizumab

Vizient, Inc. projects a 3.42% increase in hospital pharmaceutical spend in its Summer Pharmacy Market Outlook, released July 31.

Key Points: 
  • Vizient, Inc. projects a 3.42% increase in hospital pharmaceutical spend in its Summer Pharmacy Market Outlook, released July 31.
  • The overall increase, forecasted for the year beginning January 2024, is being driven by specialty pharmaceuticals and medications in the neurology service line.
  • “Specialty medications overall accounted for 51% of spending in 2022,” said Carina Dolan, associate vice president, clinical oncology, pharmacoeconomics & market insights.
  • Projections in the Vizient Pharmacy Market Outlook are based on the top 85% of Vizient Pharmacy Program participants’ aggregated purchasing volume.

FDA Approves Veklury® (Remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis

Retrieved on: 
Friday, July 14, 2023
Biotechnology, Pharmaceutical, Health, FDA, COVID-19, Infectious Diseases, Hospitals, Clinical Trials, Gilead Sciences, Chronic kidney disease, Civil service commission, Hospital, Clinical trial, EGFR, Pharmacokinetics, Virus, Medicine, Emergent virus, Kidney, Dialysis, Kidney disease, Hepatitis, Shanda, Nephrology, MD, Patient, Risk, Disease, Allergy, Science, Mortality, ESKD, Massachusetts General Hospital, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Food, European Commission, Pharmaceutical industry, Remdesivir

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.
  • With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease.
  • “Patients with advanced CKD and end-stage kidney disease (ESKD) are at high risk for severe COVID-19 with hospitalization and mortality rates remaining high, even for those who are vaccinated.
  • Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.

CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir) to Treat COVID-19 in People With Severe Renal Impairment, Including Those on Dialysis

Retrieved on: 
Friday, May 26, 2023
Health, Infectious Diseases, Hospitals, COVID-19, Pharmaceutical, Biotechnology, Gilead Sciences, Chronic kidney disease, European Medicines Agency, Committee for Medicinal Products for Human Use, Virus, Kidney disease, Emergent virus, Kidney, European Commission, Dialysis, Committee, EMA, Hepatitis, Patient, Risk, Disease, Science, Mortality, ESKD, EC, CKD, CHMP, Pharmaceutical industry, Remdesivir

The European Commission (EC) will review the CHMP recommendation and, if adopted, Veklury will become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease.

Key Points: 
  • The European Commission (EC) will review the CHMP recommendation and, if adopted, Veklury will become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease.
  • In Europe, approximately 75 million people suffer from chronic kidney disease (CKD).
  • Patients with advanced CKD or end stage kidney disease (ESKD) represent a population that is highly vulnerable to COVID-19.
  • “Gilead’s commitment to address the unmet needs of the most susceptible populations remains a top priority.

Gilead Sciences Announces First Quarter 2023 Financial Results

Retrieved on: 
Thursday, April 27, 2023
Oncology, AIDS, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Table, IRAK4, Lenacapavir, GAAP, Earnings per share, Immunomedics, Acquisition, Investment, Patient, TS, Infection, Rheumatoid arthritis, Acute lymphoblastic leukemia, Obeldesivir, Liver disease, Impact of the COVID-19 pandemic on hospitals, Research, European Congress of Mathematics, B-cell lymphoma, FTC, Growth, Immunodeficiency, FDA, Conference, IPR, Cell therapy, COVID-19, ETR, CAR, CROI, European, Tax rate, Mortality, Inflammation, Omicron, HIV, Fungal infection, Kidney, Science, EPS, Society, Breast cancer, Pharmaceutical industry, Video game, Arms industry, Vaccine, Fine chemical, Bank, Sacituzumab govitecan, Remdesivir, Brexucabtagene autoleucel

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter of 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter of 2023.
  • During the first quarter of 2023, Gilead generated $1.7 billion in operating cash flow.
  • During the first quarter of 2023, Gilead paid dividends of $969 million and repurchased $400 million of common stock.
  • First Quarter 2023 Product Gross Margin, Operating Expenses and Effective Tax Rate
    Product gross margin was 77.8% for the first quarter of 2023 compared to 78.2% for the same period in 2022.

Veklury® (Remdesivir) Efficacy and Safety Profile Further Demonstrated in Vulnerable Patient Populations

Retrieved on: 
Sunday, April 16, 2023
Health, Infectious Diseases, Hospitals, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Gilead Sciences, Omicron, Chronic kidney disease, Senior, Obeldesivir, Cancer, Pharmacokinetics, VOC, Kidney disease, Trial of the century, AKI, Plasma, Kidney, Acute kidney injury, Congress, ECCMID, MD, Patient, European, Risk, Science, Mortality, ESKD, Immunodeficiency, Death, CKD, Infection, Safety, Pharmaceutical industry, Remdesivir

A Phase 3 clinical study demonstrated that Veklury® (remdesivir) was generally well tolerated in people with moderate to severe renal impairment.

Key Points: 
  • A Phase 3 clinical study demonstrated that Veklury® (remdesivir) was generally well tolerated in people with moderate to severe renal impairment.
  • A separate real-world analysis demonstrated that use of Veklury is also associated with reduced hospital readmission risk in immunocompromised patients hospitalized with COVID-19.
  • “The breadth of clinical and real-world evidence data presented at ECCMID further support the strong efficacy and safety profile of Veklury,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences.
  • Gilead has advanced obeldesivir into two Phase 3 studies – BIRCH and OAKTREE – in broad populations and geographies to assess the efficacy and safety of obeldesivir for the treatment of non-hospitalized participants with COVID-19.