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

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 vaccine alternative, 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.

J&J’s Darzalex, in combination with two older drugs, was found to significantly extend progression-free survival in patients with relapsed refractory multiple myeloma.

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 new company is the product of a merger with Formex.

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

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

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.

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

The company plans to introduce HDX–MS in quarter three of 2016 at its West Chester, PA facility.

The company showcased new technologies at ASMS for biopharmaceutical characterization.

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.

New research presented at the American Society of Clinical Oncology meeting demonstrates that atezolizumab could be a promising first-line therapy for the treatment of bladder cancer in cisplatin-ineligible patients.

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

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

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

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.

A naturally occurring CRISPR (clustered regularly interspaced short palindromic repeats) system that specifically can be used to modify the RNA of an organism is the newest development in the technology’s evolution. A new study, published on June 2, 2016 in Science, identifies C2c2, a bacterial protein that can be used as a tool to cleave single-stranded RNA sequences at desired locations.

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

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

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

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

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