FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

King Bio is recalling several of its kids and infant products due to possible microbial contamination.

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.

The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral dose manufacturing.

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

The acquisition will strengthen Astellas Pharma’s position in ophthalmology.

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

The company’s purpose-built facility in Norwich, United Kingdom specializes in plant-based expression of proteins, metabolites, and complex natural products.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.

FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

Pharmaceutical scientist association announces upcoming term’s board of directors.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.

Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.

Ebola vaccinations by the World Health Organization began in North Kivu, Democratic Republic of the Congo, one week after the country’s latest outbreak.

The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

Denmark-headquartered pharmaceutical company LEO Pharma is set to acquire Bayer’s prescription treatment portfolio.