Remove Development Remove Genotoxicity Remove Production Remove Regulation
article thumbnail

IN FOCUS: Solvias

Pharmaceutical Technology

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict.

article thumbnail

Expert consortium comment on FDA report on risk of T-cell malignancy  

Drug Discovery World

These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container closure systems are highly regulated by health agencies.

article thumbnail

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

The Pharma Data

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 is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Food and Drug Administration (FDA). 2,3 In the U.S.,

HR 52
article thumbnail

The Future for Biotesting

Pharmaceutical Technology

The first activities of the company concerned the pre-clinical toxicological testing of several new candidate molecules showing cytostatic activity, initially developed by a former research institute, as well as the breeding and supplying of laboratory animals.

In-Vitro 130
article thumbnail

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

The Pharma Data

Chief Development Officer, Oncology, Pfizer Global Product Development. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. 2,3 In the U.S.,

HR 52
article thumbnail

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Drug discovery and development is an arduous process that can cost upwards of $2.6 This stage is more highly regulated and consists of both preclinical testing and clinical trials. These guidelines are in place to evaluate a pharmaceutical’s potential health risks, including genotoxicity, immunotoxicity, and reproductive toxicity.