Industry News

The new unit aligns existing modified-release and medication-delivery businesses of the company.

Parexo Labs, a division of Azaya, launches as a new CDMO with an emphasis on nanotechnology and liposomal manufacturing.

The core DNA-sequencing technology is based on the concept of passing a single strand of DNA through a nanometer-scale pore and reading out the sequence directly as it does so.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

Programs assist in the fast track of drugs for serious conditions.

Thermo Fisher Scientific Inc., has introduced a new-generation triple quadrupole liquid chromatography-mass spectrometry (LC-MS) platform.

Waters Corporation introduced the Waters SYNAPT G2-Si Mass Spectrometer, which integrates a third dimension of resolution and separation power.

Agilent Technologies Inc. introduced the MassHunter BioConfirm application, which allows users to rapidly create targeted screening methods.

Bruker Chemical and Applied Markets offers three LC-triple quadrupole (LC-TQ) mass spectrometers, the EVOQ Qube, the EVOQ Elite, and the EVOQ Elite ER.

Thermo Fisher Scientific Inc. introduced the Thermo Scientific Orbitrap Fusion Tribrid liquid chromatography-mass spectrometry (LC-MS) system, which combines three mass analyzers.

ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.

EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

FDA Discovers Microbial Contamination in Compound Pharmacy Products

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

Modular containment room at Belfast facility allows studies of biologics and vaccines.

Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.

New design meets new process requirements.

Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines.

Evaluation system for single-use bags and assemblies is now available for onsite testing.

New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes.

A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients.

Prefilled-syringe line features automation and novel disinfection techniques.

At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.