Pharmaceutical Technology Editors

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

A study shows significant improvement in public perceptions of clinical trial safety, trust in the motives of research professionals, and appreciation for trial volunteers.

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.

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

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.

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.

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

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.

A proposed deal with Aspen includes the GSK’s site in Notre-Dame-de-Bondeville, France.

The settlement comes after a nearly 10-year legal battle in which Pfizer and Nycomed (now part of Takeda) sought to enforce the patent for its blockbuster acid reflux medicine.

The billion-dollar deal provides strengthens J&J’s oncology portfolio.

PSL has developed a microsphere refiner for microsphere formulation, from small scale processes to commercial production.

The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented.

Eli Lilly has discontinued its Phase II study, which investigated the company's beta secretase (BACE) inhibitor, LY2886721, as a treatment for Alzheimer's disease. The decision to terminate the study was because of abnormal liver biochemical tests identified during routine monitoring.

Catalent is investing nearly $35 million in a major expansion of its controlled-release drug manufacturing facility in Winchester, Kentucky.

Almac has announced expansion of its UK facility and a new non-GMP drug development facility at the Craigavon site, representing an investment of $21.5 million.

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

USP appoints regulatory experts to elemental impurities implementation advisory group.

One employee is dismissed, another has resigned, and three others are put on administrative leave.

The multimillion-dollar deal focuses oncology.

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.