Vial

DECEMBER 11, 2023

Hepatitis C Virus (HCV) Drug Development There is an urgent need to develop novel, efficient, reliable, and cost-effective diagnostic technologies and therapeutic and immune prophylactic interventions to manage HCV. The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

They are called immune modulators because they help to minimize the effects of an overactive immune response in some COVID-19 patients. This response, called a “cytokine storm,” can lead to acute respiratory distress syndrome, multiple organ failure, and other life-threatening complications.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. Food and Drug Administration (FDA)-approved drug library, some of which inhibit E. tuberculosis. coli bacteria from growing. However, hope prevails.

Vaccine 83

Vaccine Trials Therapies Treatment 83

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Source: Regeneron. Posted: November 2020.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Casirivimab and imdevimab injection is not FDA approved for any use. did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals 52

Hospitals Production Clinical Trials Therapies 52

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. On November 23, the FDA published a new, direct-to-final post-PHE version of the document.

FDA 40

FDA Clinical Trials Vaccine Trials 40

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

JULY 6, 2021

The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. There are currently no FDA-approved treatment options for FTD.

Disease 52

Disease Science Treatment Clinical Development 52

The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. This indication is approved under accelerated approval based on tumor response rate and duration of response.

Vaccine 40

Vaccine Trials Treatment Virus 40