Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

The company showcased new technologies at ASMS for biopharmaceutical characterization.

The company opened a 200,000-square-foot facility in Kakegawa, Japan to serve the needs of domestic and global clinical trial sponsors.

MilliporeSigma surveyed 250 biopharmaceutical executives on how their companies will manage new risks associated with the changing biopharmaceutical landscape.

The new company is the product of a merger with Formex.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

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.

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.

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.