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.

Development 130

Development Manufacturing Production Vaccination 130

Drug Discovery World

JANUARY 10, 2024

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.

Gene Therapy 59

Gene Therapy Genotoxicity Gene Genetics 59

XTalks

MAY 13, 2022

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.

Packaging 98

Packaging Packaging Containment Production 98

Pharmaceutical Technology

SEPTEMBER 10, 2008

NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.

In-Vitro 130

In-Vitro Genotoxicity In-Vivo Clinical Research 130

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 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

HR Clinical Trials Clinical Trials Containment 52

FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

In-Vivo 45

In-Vivo Manufacturing Engineer Genotoxicity 45

The Pharma Data

MARCH 25, 2021

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

HR Clinical Trials Clinical Trials Trials 52