Industry News

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.

The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.

The Michelson Medical Research Foundation and the Human Vaccines Project have awarded three young scientists $150,000 for their novel approaches toward human immune system research.

ABPI has published a guide for pharmaceutical companies on how to work successfully, collaboratively, and ethically with patients and patient groups, in line with the ABPI Code of Practice.

Vida International received an FDA warning letter after an inspection found quality control violations.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO in Philadelphia.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

ERS Genomics and Bioneer have revealed the signing of a license agreement for access to CRISPR/Cas9 genome editing technology intellectual property.

Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.

FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.