News

Sterigenics International will triple West Memphis sterilization capacity with $15 million expansion.

The Grünenthal Group’s Tecnandina manufacturing plant in Ecuador has received the country’s first certification from the Regulatory Authority of Brazil.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.

The results from an international study on nivolumumab, published in the New England Journal of Medicine, suggest a paradigm shift in the standard of care for previously treated lung cancer patients.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

Pharma development and manufacturing firm Patheon announces new tagline and logo.

The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

MedImmune and 3M Drug Delivery Systems collaborate to develop toll-like receptor (TLR) agonists for immuno-oncology.

Stephen J. Ubl to succeed John J. Castellani as the next president and chief executive officer of PhRMA.

US Compounding, Inc. issues voluntary recall of all sterile products.

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

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.

IMA Active’s new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.

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.