BioPharm International Editors

Tosoh Bioscience adds TOYOPEARL Sulfate-650F, a strong cation exchange resin that exhibits high salt tolerance, to its process media product line.

A PESU membrane is now available for Sartorius Stedim Biotech Sartocon benchtop and production-scale filtration assemblies.

Bio-Rad Laboratories’ Nuvia IMAC Resin, an immobilized metal affinity chromatography resin, is optimized for use from laboratory-scale through pilot studies to process-scale manufacturing.

Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn’s disease.

The new company will focus on R&D of cancer treatments.

The Phase III trial examined guselkumab compared with a placebo and Humira at treating moderate-to-severe plaque psoriasis.

The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.

The company invested in a new cGMP facility located in Berlin, Germany.

ViraTherapeutics will develop its VSV-GP therapy alone and in combination with other therapies.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.

PaizaBio will add aseptic injectable production capacity in Hangzhou, China.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Could grading finished-drug manufacturers on their quality and efficiency lead to greater transparency, improve quality and reduce drug shortages?

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Onset expanded its product line for pharmaceutical cold-chain management with the launch two new products.

The most recent PharmSource report says bio/pharma companies have spent more than $150 billion for new plant equipment in the past five years.

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

FDA and EMA set up new working group on the development of treatments for rare diseases.

Pfizer announced its decision to remain one company after debating the possibility of splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies.

HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

R-Pharm Group, a private Russian pharmaceutical company, has opened a biopharmaceutical production plant in Yaroslavl, Russia, to produce biologics and biosimilars to treat autoimmune diseases and cancer. The facility, which has a line capacity is 2,000 L of cell culture per production cycle, is ready to be validated to US and Russia FDA and GMP requirements, the company reports.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

Mucodel reported that the study met its objectives, and effectively delivered a dose of naloxone using an oromucosal route.