A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

Uncertainty about the demand for a biologic medication can be partly mollified with some well-planned capacity outsourcing, contends a new report by ORC International sponsored by Patheon.

An article in Nature Reviews Drug Delivery reports the clinical success rates of biologics, and these numbers differ from those recently highlighted in a similar BIO study.

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

Amyris will use its platform technology to develop a library of natural and natural-like compounds to test against Janssen’s therapeutic target.

The agency published a report on fostering the development of advanced therapy medicinal products.

Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Process analytical technology paved the way for continuous manufacturing.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.

Production of kilogram-scale batches of synthetic molecules for early-stage development are now available to US customers.

As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.

During its May 2016 meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.

The Start-up Hub is designed to give start-up companies the opportunity to network at Pharmapack.

The company opened its 62,000 square foot facility, called the BioProcess Innovation Center, in Triangle Park, NC.

The company opened a new sales office located in Seoul, South Korea.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

Pharma has voiced strong opposition against Britain’s departure from the EU.

Jazz will acquire Celator for approximately $1.5 billion.

FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.

The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Lagarde will be based out of the company’s Boston office and will lead Patheon’s global corporate and cross-enterprise operations.

PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.