News

The company installed a ZSE-3D twin screw extrusion system at its Somerville, NJ process laboratory.

The acquisition will support Novo Nordisk’s development of glucose-responsive insulins.

FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.

The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.

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.

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.

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.