News

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Alcami and the University of North Carolina Wilmington received a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to prepare students for careers in pharmaceutical sciences.

The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.

Girish Malhotra argues in CPhI Annual Report that shorter approval times and financial incentives are needed to promote manufacturing improvements.

Flush solutions for liquid chromatography mass spectrometry (LC-MS) systems and ultrapure solvents for ultra-high-performance LC-MS systems from Thermo Fisher Scientific can minimize interference and maximize lab instrument uptime.

Shimadzu’s Imagereveal MS mass spectrometry imaging data analysis software can analyze large sets of data or simultaneously analyze multiple sets of data.

The acquisition strengthens Nelson Labs’ outsourced testing capabilities for the pharmaceutical and medical device industries.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

The TSQ Fortis Triple Quadrupole Mass Spectrometer from Thermo Fisher Scientific offers fast, robust liquid chromatography-mass spectrometry (LC-MS/MS) analysis for clinical research laboratories.

The Lumis electron backscatter diffraction (EBSD) detector incorporates a large-format complementary metal oxide semiconductor (CMOS) sensor to enable higher sample throughput, higher resolution measurements, and precise phase identification.

The company’s new electron microscopy and microanalysis solutions offer scientists enhanced research capabilities.

Bristol-Myers Squibb appointed a new executive vice-president and chief commercial officer from within the company, effective immediately.

The company is certified as a manufacturer of pressure vessels and components for use in China.

Pharma packaging manufacturer Sanner has expanded capacity at its site in Budapest, Hungary.

The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.

Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.

An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.

Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.

The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

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.