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Emergent Biosolutions (EBS)
:EBS
Brincidofovir
Smallpox
Phase I
Completed
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
Jun 05, 2023
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Chikv Vlp/Adjuvant
Chikungunya Virus
Phase III
Completed
Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years
Apr 21, 2022
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16 Mg Naloxone Ap003, 8 Mg Naloxone Narcan Nasal Spray
Opioid Overdose
Phase I
Completed
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
Mar 11, 2022
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Stabilized Isoamyl Nitrite (Sian)
Cyanide Poisoning
Phase I
Completed
Study of SIAN Nasal Spray in Healthy Adults
Jan 04, 2022
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Covid-Hig
Sars-Cov-2 Infection
Phase I
Completed
A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults
Nov 30, 2021
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Uflua 20 Μg Each Antigen/Dose, Uflua 60 Μg Each Antigen/Dose
Human Influenza
Phase I
Completed
Universal Influenza A Vaccine in Healthy Adults
Nov 25, 2021
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Chikv Vlp/Adjuvant
Chikungunya Virus
Phase III
Completed
A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine)
Sep 28, 2021
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Chikv Vlp, Adjuvanted
Chikungunya Virus
Phase II
Completed
A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine
Sep 23, 2021
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Covid-Higiv
Covid-19
Phase I
Completed
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
Dec 09, 2020
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Av7909, Ciprofloxacin 500Mg Tablet, Doxycycline 100Mg Tablet
Anthrax
Phase II
Completed
Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Jul 15, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Emergent Biosolutions (EBS) have in its pipeline
EBS is currently developing the following drugs: Brincidofovir, Chikv Vlp/Adjuvant, 16 Mg Naloxone Ap003, 8 Mg Naloxone Narcan Nasal Spray. These drug candidates are in various stages of clinical development as the company works toward FDA approval.