XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

Packaging 98

Packaging Packaging Containment Production 98

The Pharma Data

FEBRUARY 8, 2021

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. Food and Drug Administration (FDA). hypoxia, cough, dyspnea).

HR 52

HR Containment Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 25, 2021

The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation. The validation of our EU marketing application is an important step toward addressing the significant unmet medical need for people with metastatic triple-negative breast cancer.”.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

Camargo

APRIL 20, 2021

Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies. Build a Pitch and Team That Appeal to Investors. A strong IP position.

Development 137

Development Genotoxicity Production Drugs 137

The Pharma Data

APRIL 7, 2021

The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. All filings are based on data from the Phase 3 ASCENT study.

HR 52

HR Genotype FDA Approval Genotoxicity 52