Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

A skilled workforce is needed to deliver on technology’s promising medical advances.

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.

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

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

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

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.

The event, taking place on June 6–7, 2018 in Clinton and Somerville, NJ, will focus on the latest melt extrusion and granulation technologies for pharmaceutical and nutraceutical products.

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

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

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.

Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.

The company will add a new $5-million drug development center of excellence at its facility and headquarters in Somerset, NJ.

Grand River Aseptic Manufacturing announces equipment purchase to add vial filling capacity.

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.

Porton will use biocatalyst technologies from Codexis to accelerate API development for clients.

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

A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.

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.