Winners from the seven categories will be announced live at the event in Madrid.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.

Novo Nordisk will build a local manufacturing plant for FlexPen prefilled insulin delivery devices in Iran.

ReposiTrak signs agreement to pilot track and trace system in pharma.

The company will showcase its range of drug packaging and delivery systems as well as launch a new ready-to-use validated packaging component.

Intuniv (guanfacine hydrochloride prolonged-release tablets) is the first selective alpha-2A adrenergic receptor agonist licensed for the treatment of attention deficit hyperactivity disorder in Europe.

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.

Exports and domestic market have each been valued at more than US$15 billion.

West Pharmaceutical Services and HealthPrize Technologies are collaborating on self-reporting and bar coding capabilities for injectable drug-delivery systems.

The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.

BASF is working together with top universities to develop a new supersonic spray-drying process for production of stable and soluble amorphous nanoparticles.

Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile pharmaceutical manufacturing process, including vial filling; operators share best practices for cleaning.

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

EDQM clarifies elemental impurities guidelines for veterinary and other products.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.

The Duran Group’s acquisition of Wheaton combine two brands of laboratory consumables.

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.

GS1 standard tracks movement and status of goods, enabling better visibility, security and regulatory compliance.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

PharmSource forecasts slow growth in a new report on the outlook for the contract manufacturing industry.

According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.