News

CN Bio and LifeNet Health LifeSciences Partner to Supply Pre-Validated Cells

September 20, 2023

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Staying Compliant in 2023

September 20, 2023

Leaders at CDER and CBER give update on organizational changes at FDA.

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

September 19, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

Pharma Award Finalists for CPHI Barcelona Have Been Announced

September 19, 2023

The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.

EMA Prepares for Regulation on Health Technology Assessment

September 19, 2023

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

FDA Approves Treatment for Myelofibrosis Patients with Anemia

September 19, 2023

Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.

Being Innovative in CGMP Training While Adapting to Change

September 19, 2023

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment

September 19, 2023

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

September 18, 2023

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

FDA Issues Guidance on Biosimilar Labeling

September 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.