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

The Pharma Data

Comer will oversee a team of physicians and nurses led by Jeanne Manubay, MD, the study’s medical director, who is monitoring the patients’ response to the vaccine, including their subsequent drug use and behaviors.

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

The Pharma Data

This approval is based on results from a multicenter, open-label, actively controlled clinical trial evaluating DALVANCE in pediatric patients from birth to less than 18 years of age with ABSSSI and 3 pharmacokinetic studies. There are no adequate and well-controlled studies with DALVANCE use in pregnant or nursing women.

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2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

Roche will present data on the increased use of home nursing capabilities in the Phase III GRADUATE studies of gantenerumab during the COVID-19 pandemic, which enabled home-bound trial participants to continue dosing to maintain medicine exposure. Alzheimer’s Disease (AD). P1: Aging and Dementia: Biomarkers.

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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

This trial is a multicenter, randomized, double-blind, placebo-controlled, ascending, dose-finding, adaptive Phase 2 study designed to evaluate the safety, pharmacokinetics and efficacy of BXCL501 in intensive care unit patients experiencing agitation associated with delirium, including COVID-19 patients.

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Stoke Therapeutics Announces Presentations Related to the Company’s Work to Advance STK-001, the First Potential New Medicine to Target the Underlying Cause of Dravet Syndrome at the American Epilepsy Society (AES) 2020 Annual Meeting

The Pharma Data

Safety and Pharmacokinetics of Antisense Oligonucleotide STK-001 in Children and Adolescents with Dravet Syndrome: Single and Multiple Ascending Dose Design for the Open-Label Phase 1/2a MONARCH Study. The primary endpoints are safety, tolerability and pharmacokinetic (PK) profile of STK-001 in Dravet syndrome patients.

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FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. The most common adverse reactions (?10%) Source link:[link].

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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. The most common adverse reactions (?10%) About Pfizer Oncology.