XTalks
JUNE 21, 2024
The European Union (EU) recently introduced a ban on eight artificial smoke flavorings used in various food products. The European Food Safety Authority (EFSA) found that smoky flavorings can contain harmful chemicals formed during the smoking process. The ban targets artificial smoke flavorings linked to genotoxicity concerns.
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.
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Pharmaceutical Technology
DECEMBER 9, 2022
M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Pharmaceutical Technology Excellence Rankings – The Verdict.
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. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. DISCLOSURE NOTICE : The information contained in this release is as of February 5, 2021.
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. SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Embryo-Fetal Toxicity.
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.
The Pharma Data
APRIL 7, 2021
TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
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