USP focuses on building worldwide partnerships in standards-setting activities.

Pharma and biotech companies, with the rest of the health care industry, must face change.

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

As the dreaded patent cliff continues to haunt the pharmaceutical industry, some companies are resorting to desperate measures to delay generic drug entry into the market.

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.

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

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

The US Food and Drug Administration has approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older.

Mettler Toledo's global weighing standard, GWP, can help pharmaceutical manufacturers meet the new requirements of USP Chapter 41 and Chapter 1251.

The US Food and Drug Administration took action against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers.

Hermes Pharma announced that the company completed a successful inspection by the US FDA of its production facility located in Wolfratshausen, Germany.

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

The FDA approved Brisdelle (paroxetine) to treat moderate to severe hot flashes.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended 10 new medicines for approval, including the first two monoclonal antibody biosimilars, and a new advanced therapy medicine.

Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.

Eisai has launched a new dry syrup formulation of its Alzheimer's disease treatment Aricept (donepezil hydrochloride) in Japan.

The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.

The move is part of a strategy to cultivate innovation in key regions.

Serelaxin, to treat acute heart failure, is the second Novartis drug to get new designation from FDA.

Entries open to any company across three categories - formulation, process development and best packaging.

Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.

Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.

NIH awards $12.7 million for collaborations between nine academic research groups and pharmaceutical industry partners to explore new treatments.

Lundbeck and eight other pharmaceutical companies have been fined for delaying generic entry of the blockbuster antidepressant, Celexa (citalopram), into the market.

New production capabilities in Normandy, France will include a cleanroom.

A screening method predicts delamination in primary packaging.

Semi-automatic technology aids egg-based influenza vaccine production in smaller facility footprints.

The multimillion investment in a facility in Cambridge is part of the company's move to create strategic global R&D centers in the UK, US and Sweden.