Remove FDA Approval Remove Pharmacokinetics Remove Vaccine
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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. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.

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Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients. . Please see full Prescribing Information for more details. Use in Specific Populations.

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ChEMBL 34 is out!

The ChEMBL-og

71 out of the 882 newly added EMA drugs are only authorised by EMA, rather than from other regulatory bodies e.g. FDA. For legacy AUC and Cmax records (< ChEMBL 34), pharmacokinetic parameters have been extracted from the assay descriptions using regular expression matching (RegEx).

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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The FDA approval was based on the review of a comprehensive data package which demonstrated biosimilarity of ABRILADA to the reference product.

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Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

The Pharma Data

The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. About the Phase 1/2 Trial.

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New Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Achieved Complete Skin Clearance and Favorable

The Pharma Data

TREMFYA q4w is not currently FDA-approved. Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. •

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Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Agency IQ

The examples provided from the agency both relate to studies of infectious disease: the assessment of an antimicrobial agent or a preventive vaccine in well-established infection models. The guidance notes that this is separate from FDA’s Animal Rule pathway, which was originally developed to respond to bioterrorism.

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