Industry News

The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.

Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.

The guidance describes a risk-based approach to monitoring of clinical trials.

The companies initially focused on five biosimilar products.

Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.

The licensed cell line combines BioWa's engineered glycosylation Potelligent Technology with Lonza's GS Gene Expression System.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

FDA releases FY 2014 generic-drug user fees.

EMA restructures organization.

EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.

Molecular Profiles has opened a new clinical manufacturing facility following a successful inspection from the Medicines and Healthcare products Regulatory Agency.

Almac's Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products.

Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.

The facility, which includes state-of-the-art formulation, analytical and synthetic laboratories as well as a customer training center, will focus on bioavailability enhancement and oral dosage formulations.

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.