Products & Portfolio (30)
5 discontinued products not shown
BIKTARVY
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Peak
ORAL · TABLET
Nucleoside Reverse Transcriptase Inhibitors
2018
0
CAYSTON
aztreonam
LOE Approaching
INHALATION · FOR SOLUTION
12.1 Mechanism of Action Aztreonam is an antibacterial drug [see ] . 12.3 Pharmacokinetics Sputum Concentrations Sputum aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in clinical trials. The mean sputum concentration 10 minutes following the first dose of CAYSTON (n = 195 patients with CF) was 726 mcg/g. Mean sputum concentrations of aztreonam in patients receiving CAYSTON 3 times a day for 28 days were 984 mcg/g, 793 mcg/g, and 715 mcg/g 10 minutes after dose administration on Days 0, 14, and 28, respectively, indicating no accumulation of aztreonam in sputum. Plasma Concentrations Plasma aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in the clinical trials. The mean plasma concentration one hour following the first dose of CAYSTON (at approximately the peak plasma concentration) was 0.59 mcg/mL. Mean peak plasma concentrations in patients receiving CAYSTON 3 times a day for 28 days were 0.55 mcg/mL, 0.67 mcg/mL, and 0.65 mcg/mL on Days 0, 14, and 28, respectively, indicating no systemic accumulation of aztreonam. In contrast, the serum concentration of aztreonam following administration of aztreonam for injection (500 mg) is approximately 54 mcg/mL. Absorption Evaluation of plasma and urine aztreonam concentrations following administration of CAYSTON indicates low systemic absorption of aztreonam. Approximately 10% of the total CAYSTON dose is excreted in the urine as unchanged drug, as compared to 60–65% following intravenous administration of aztreonam for injection. Distribution The protein binding of aztreonam in plasma is approximately 77% within the clinical dose range of concentrations achieved following CAYSTON administration. Metabolism Following intramuscular administration of aztreonam for injection 500 mg every 8 hours for 7 days, approximately 6% of the dose was excreted as a microbiologically inactive open β-lactam ring hydrolysis product in an 8-hour urine collection on the last day of multiple dosing. Excretion The elimination half-life of aztreonam from plasma is approximately 2.1 hours following administration of CAYSTON to adult patients with CF, similar to what has been reported for aztreonam for injection. Approximately 10% of the total CAYSTON dose is excreted in the urine as unchanged drug. Systemically absorbed aztreonam is eliminated about equally by active tubular secretion and glomerular filtration. Following administration of a single intravenous dose of radiolabeled aztreonam for injection, about 12% of the dose was recovered in the feces. 12.4 Microbiology Mechanism of Action Aztreonam exhibits activity in vitro against Gram-negative aerobic pathogens including P. aeruginosa . Aztreonam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis and death of the cell. Aztreonam activity is not decreased in the presence of CF lung secretions. Sus
respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa
2010
30
COMPLERA
emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Peak
ORAL · TABLET
Nucleoside Reverse Transcriptase Inhibitors
2011
0
DESCOVY
emtricitabine and tenofovir alafenamide
Peak
ORAL · TABLET
Nucleoside Reverse Transcriptase Inhibitors
HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agentsincluding darunavircobicistat but not other protease inhibitors+7 more
2016
0
EMTRIVA
emtricitabine
LOE Approaching
ORAL · CAPSULE
Nucleoside Reverse Transcriptase Inhibitors
combination with other antiretroviral agents for the treatment of HIV-1 infection
2003
30
EMTRIVA
emtricitabine
LOE Approaching
ORAL · SOLUTION
Nucleoside Reverse Transcriptase Inhibitors
combination with other antiretroviral agents for the treatment of HIV-1 infection
2005
30
EPCLUSA
velpatasvir and sofosbuvir
Peak
ORAL · PELLETS
Breast Cancer Resistance Protein Inhibitors
older with chronic HCV genotype 16 infection (): without cirrhosiscompensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin+1 more
2021
0
EPCLUSA
velpatasvir and sofosbuvir
Peak
ORAL · TABLET
Breast Cancer Resistance Protein Inhibitors
older with chronic HCV genotype 16 infection (): without cirrhosiscompensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin+1 more
2016
0
GENVOYA
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
Peak
ORAL · TABLET
Cytochrome P450 3A Inhibitors
2015
0
HARVONI
ledipasvir and sofosbuvir
Peak
ORAL · PELLETS
RNA Replicase Inhibitors
2019
0
HARVONI
ledipasvir and sofosbuvir
Peak
ORAL · TABLET
P-Glycoprotein Inhibitors
2014
0
LETAIRIS
ambrisentan
Peak
ORAL · TABLET
Endothelin Receptor Antagonists
2007
0
Pipeline & Clinical Trials
WelTel
HIVClinical Trials (1)
NCT02603536WelTelOAKTREE: Text Messaging to Support Patients With HIV/AIDS in British Columbia
N/ANeurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond
CAR T Cell TherapyClinical Trials (1)
NCT07375628Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond
N/AN/A
Clinical Trials (1)
NCT05095818Impact of Nursing Involvement on Implementation of HIV Prevention Services
N/ANewSpringForMe digital solution
Hematologic DiseasesClinical Trials (1)
NCT06148610Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
N/Atenofovir disoproxil fumarate
Chronic Hepatitis BClinical Trials (5)
NCT02957864Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide
Phase 4NCT02616783Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years
Phase 3NCT01745822Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand
Phase 3+2 more
GeneXpert HCV VL Fingerstick test
Hepatitis C, ChronicClinical Trials (1)
NCT04610762HCV RNA Fingerstick Assay as Useful Point of Care of Diagnostic Tool for Drug Users in Brussels
N/ADigital nutritional program
Metabolic Dysfunction-Associated Steatotic Liver DiseaseClinical Trials (1)
NCT07456332Effect on Body Weight Reduction of a Behavioral Intervention on Lifestyle Using a Digital Nutritional Program in People Living With HIV and Metabolic Dysfunction-associated Steatotic Liver Disease
N/AAdaptability of an Undetectable = Untransmissible Model for HBV
Chronic Hepatitis bClinical Trials (1)
NCT07449091Adaptability of an Undetectable = Untransmissible Model for HBV
N/ABiopsies and bloood samplings
HIV-1-infectionClinical Trials (1)
NCT05222945A Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing bictégravir, Emtricitabine and ténofovir alafénamide
N/AEC clinic support - whole of practice interventions delivery through nurse-led model
Hepatitis CClinical Trials (1)
NCT04061551Eliminate Hepatitis C/EC Partnership Evaluation Protocol
N/ABurden of Hepatitis D Virus (HDV) Infection in Italy
Chronic Hepatitis DClinical Trials (1)
NCT05723068Burden of Hepatitis D Virus (HDV) Infection in Italy
N/AFinancial Incentive
Pre-Exposure ProphylaxisClinical Trials (1)
NCT03078153Effect of Social Media Support and Financial Incentives on PrEP Adherence
N/ARemdesivir
COVID-19Clinical Trials (1)
NCT04582266PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US
N/AAxicabtagene Ciloleucel
Large B-cell LymphomaClinical Trials (1)
NCT05776160Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
N/ANo intervention
Breast CancerClinical Trials (2)
NCT00645736CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study
N/ANCT06683482A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
N/ADirectly Observed Therapy
HEPATITIS CClinical Trials (1)
NCT02573376Antiviral Pharmacology and Adherence in Drug Users
N/ABulevirtide
Chronic Hepatitis Delta Virus InfectionClinical Trials (1)
NCT06780579Expanded Access for Bulevirtide
N/AB/F/TAF
HIV-1-infectionClinical Trials (1)
NCT03580668Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
N/AThe Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'
HIV PositiveGS-4774
Chronic Hepatitis BClinical Trials (1)
NCT02258581Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
N/AVirtual clinical visits with home lab kits and mailed HIV PrEP
HIV InfectionsClinical Trials (1)
NCT05319613Reducing Disparities in Rural HIV Prevention
N/ARapid Treatment strategy
Hepatitis CClinical Trials (1)
NCT03627546HCV Seek, Test and Rapid Treatment for Young PWID
N/AA Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir in HIV-H
HIV InfectionsClinical Trials (1)
NCT00660361A Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir in HIV-HBV co-Infected Patients
N/ASOF
Hepatitis CClinical Trials (1)
NCT02562742Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
N/AELISA testing
Hepatitis BClinical Trials (1)
NCT01767597Application of HBV Rapid Tests as a Tool for Wide-Use Screening
N/AIdelalisib
Chronic Lymphocytic LeukaemiaClinical Trials (1)
NCT03582098Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
N/ABulevirtide
Chronic Hepatitis D InfectionClinical Trials (1)
NCT05718700Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
N/Abirth dose vaccination against hepatitis B strategy
Hepatitis BClinical Trials (1)
NCT04029454Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule
N/ATelePrEP
HivClinical Trials (1)
NCT05520905TelePrEP for At-risk Youth in Colorado
N/AHepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in th
Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected SubjectsClinical Trials (1)
NCT02196064Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."
N/ASofosbuvir
Hepatitis C VirusClinical Trials (1)
NCT02907996Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
N/ABiospecimen Collection
Absence of Signs or SymptomsClinical Trials (1)
NCT02928510Mechanisms of Idelalisib-Associated Diarrhea in Patients With Relapsed Chronic Lymphocytic Leukemia, Indolent Non-hodgkin Lymphoma, or Small Lymphocytic Lymphoma
N/ASymptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery
Pulmonary HypertensionClinical Trials (1)
NCT01646541Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery
N/AEvaluating the Chain of Addiction Care (CAC)
Hepatitis C, ChronicClinical Trials (1)
NCT05401136Evaluating the Chain of Addiction Care (CAC)
N/AHepatitis C Treatment Alerts in CHORUS™
Hepatitis CClinical Trials (1)
NCT05725109Hepatitis C Diagnosis to Treatment Management
N/ANAVAH
Breast CancerClinical Trials (1)
NCT05978232NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
N/ABictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
HIV-1-infectionClinical Trials (1)
NCT05064020Bictegravir in the Elderly Living With HIV (BICEP)
N/AA chatbot designed to promote PrEP awareness and uptake for Black MSM
HIV PreventionClinical Trials (1)
NCT05968755Leveraging Chatbot to Improve PrEP in the Southern United States
N/ATenofovir disoproxil fumarate
HIV InfectionsClinical Trials (1)
NCT01066858Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding
N/AEffects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patien
HIVClinical Trials (1)
NCT01766726Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients
N/AN/A
Clinical Trials (1)
NCT01505179The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction
N/ARemdesivir
SARS-CoV2 InfectionClinical Trials (1)
NCT04323761Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)
N/ACT scan
COVID-19 PneumoniaClinical Trials (1)
NCT04868864The Ontario Multi-Regional Hospital COVID-19 Registry (COREG)- Recovery Trajectory Sub-study
N/ARnalozine
Coronary MicrocirculationClinical Trials (1)
NCT01815957Impact of Ranolazine on Coronary Microcirculatory Resistance
N/APalbociclib
Metastatic Breast CancerDescovy
HIV PreventionClinical Trials (1)
NCT05690815Express Testing and Same-day Initiation of PrEP Study
N/ACOVID-19
HIV-1-infectionClinical Trials (1)
NCT05481216HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
N/ATenofovir Alafenamide
Chronic Hepatitis bClinical Trials (1)
NCT03752658TAF Real World Study for Universal Effectiveness
N/ARanolazine
CardiomyopathyClinical Trials (1)
NCT01705509The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients (ERIC)
N/AA Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjec
Limited SclerodermaClinical Trials (1)
NCT01881529A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
N/AOpen Jobs (267)
Cell Therapy Account Manager(北陸)
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CommercialJust now
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Interview Prep Quick Facts
Portfolio: 35 approved products, 153 clinical trials
Top TAs: Infectious Diseases, Oncology, Cardiovascular
H-1B (2023): 1 approval
Publications: 25 in PubMed
SEC Filings: 2 available
Open Roles: 267 active jobs
Portfolio Health
Launch2 (6%)
Growth1 (3%)
Peak24 (69%)
LOE Approaching8 (23%)
35 total products
Therapeutic Area Focus
Infectious Diseases
23 marketed597 pipeline
Oncology
1 marketed285 pipeline
Cardiovascular
1 marketed67 pipeline
Immunology
42 pipeline
Rare Diseases
1 marketed27 pipeline
Metabolic Diseases
28 pipeline
Gastroenterology
1 marketed22 pipeline
Respiratory
19 pipeline
Marketed
Pipeline
Hiring Trend
Actively Hiring
267
Open Roles
+268
Added
-1
Filled/Removed
Based on last 2 crawl cycles
Visa Sponsorship
Sponsors Work Visas
H-1B Petitions (FY2023)
1
Approved
0
Denied
100%
Rate
Source: USCIS H-1B Employer Data Hub