BioPharm International Editors

Articles

LIfT BioSciences and Minaris Regenerative Enter Cell Therapy Partnership

LIfT and Minaris will work together to develop a manufacturing process for LIfT’s allogeneic neutrophil progenitor cell therapy.

FDA Publishes New Product-Specific Guidelines for Generic Drug Development

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

FDA Announces BsUFA III Regulatory Science Program to Support Future Research

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

Bayer Names Bill Anderson as CEO

Bill Anderson, former CEO of Roche’s pharmaceutical division, will take over as CEO of Bayer on June 1, 2023.

GenScript PrioBio and Bio Immunitas Announce Platform Collaboration

GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.

Charles River Launches Novel IgY-based ELISA Kit

The kit is meant for use for the detection and quantitation of residual host cell protein.

New Data from EMA’s Review of Medicines with Pseudoephedrine

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.

FDA Accepts Biologics License Application for Proposed Biosimilar Denosumab

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

Elektrofi Establishes Contract Manufacturing Agreement with Thermo Fisher Scientific

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

Roche Reports Positive Data for Rare Blood Condition Treatment

Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.