BioPharm International Editors

InstantGMP INV is a validated software for real-time material tracking and inventory control in biopharmaceutical manufacturing.

The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.

Johnson & Johnson’s Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen’s immunotherapy platform.

Takeda expands its global and therapy base with announced acquisition of Shire.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.

GE Healthcare’s new Sefia S-2000 cell processing system allows operators to conduct multiple cell therapy manufacturing steps with one instrument.

The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.

The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.

The companies plan to advance programs for dementia and other neurological conditions.

As Astellas Pharma winds down its Agensys research operations, the company sells the Santa Monica, CA, facility to Gilead.

Geofrey Wyatt has been named CEO and Clifford Wyatt named president of Wyatt Technology.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

The company’s investment in new laboratory equipment and personnel will strengthen its cell line development services.

The company doubled capacity for laboratory services at its facility in Itasca, IL.

The company showcased newer products and equipment for cell culture laboratories at Analytica 2018 in Munich, Germany.

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.

Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.

Thermo Fisher Scientific invests $50 Million to expand biologics drug development and manufacturing capabilities in St. Louis, MO.

The new platform is expected to speed up cell line development.

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.