Gilead Sciences - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 2 supporting sources.

Score 1002 references

Featured Reference

Managed Access at Gilead SciencesOpens in new window

“When it isn't possible for a patient to enroll in a clinical trial, we consider requests for access to the medical products for individual patient use, or through an expanded access protocol when appropriate.”

Gilead Sciences Medication Access ProgramsSource

“Managed access provides eligible patients with serious or life-threatening conditions with access to medicinal products for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Managed access encompasses compassionate use, expanded access, early access and individual patient use.”

EAP Related Articles from Sponsor

Score contribution: 80 — 6 supporting sources.

Score 806 references

Featured Reference

Gilead Sciences Announces Start of Expanded Access Program for PREVEONOpens in new window

Gilead Sciences, Inc. today announced an expanded access program for PREVEON; (adefovir dipivoxil) for people with advanced HIV infection in the United States who have limited treatment options.

Gilead Announces Start of Early Access Program for Investigational Anti HIV Agent Tenofovir DF in United States and FranceSource

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the initiation of a limited expanded access program to provide tenofovir disoproxil fumarate (tenofovir DF) to people with advanced human immunodeficiency virus (HIV) infection in the United States and multiple countries in the European Union.

Gilead Announces Expanded Access Program for Aztreonam Lysine for Inhalation for Patients with Cystic FibrosisSource

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company will initiate an expanded access program beginning August 1, 2007 to provide its investigational therapy, aztreonam lysine for inhalation, to patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (P. aeruginosa) infection who have limited treatment options and are at risk for disease progression. The expanded access program for aztreonam lysine for inhalation will be open to participating treatment centers in the United States.

Gilead Statement on Discontinuation of Phase 3 ENHANCE-3 Study ...Source

FDA Places Full Clinical Hold on All Magrolimab AML and MDS Studies, Including Expanded Access Programs

Gilead Announces Partial Clinical Hold for Magrolimab Studies in AMLSource

Effective immediately, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused.

4 Questions with Diana BrainardSource

She and her team have been collaborating with others at Gilead and external partners around the world to coordinate clinical studies, expanded access programs and emergency access for the company’s investigational COVID-19 treatment, remdesivir.

Active EAPs on ClinicalTrials.gov

Score contribution: 60 — 1 supporting sources.

Score 601 references

Featured Reference

Expanded Access for BulevirtideOpens in new window

Conditions: Chronic Hepatitis Delta Virus Infection

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 8 supporting sources.

Score 408 references

Featured Reference

Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis COpens in new window

Conditions: Post-transplant Hepatitis C

Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic FibrosisSource

Conditions: Cystic Fibrosis, Pseudomonas Aeruginosa

Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway InfectionSource

Conditions: Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection

US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid LeukemiaSource

Conditions: Relapsed/Refractory Acute Myeloid Leukemia

Expanded Access for IMMU-132Source

Conditions: Metastatic Triple-Negative Breast Carcinoma

Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic LeukemiaSource

Conditions: Chronic Lymphocytic Leukemia (CLL)

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