Remove FDA Approval Remove Nurses Remove Pharmacokinetics Remove Trials
article thumbnail

First-in-human clinical trial for a vaccine to treat opioid use.

The Pharma Data

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

article thumbnail

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

The Pharma Data

The Company plans to initiate a Phase 2 trial within the next several months. “We An exploratory endpoint of this trial will be to determine the overall clinical improvement after drug administration using the Clinical Global Impression – Improvement Scale (“CGI-I”).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

The Pharma Data

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

article thumbnail

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

New 2-year findings from Part 2 of the Phase II/III FIREFISH trial show longer-term efficacy and safety of EVRYSDI in infants with symptomatic Type 1 SMA treated with EVRYSDI. Multiple Sclerosis (MS). Neuromyelitis Optica Spectrum Disorder (NMOSD). Roche will present five sets of data on adults living with NMOSD. Alzheimer’s Disease (AD).

article thumbnail

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. It remains under review by the FDA. INDIANAPOLIS, Jan.