Pharmaceutical Technology Editors

Agilent’s new facility in Folsom, California includes laboratory, order fulfilment, and warehousing space.

Mylan signed a sub-license agreement with the Medicines Patent Pool to develop a generic version of daclatasvir to market in developing countries.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

FDA has revised its draft guidance to provide greater clarity and focus. This version would establish an initial voluntary phase to allow regulators and industry to focus, first, on a limited set of metrics.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor

PCI is extending its cryogenic storage capabilities to its Rockford, Illinois operations to support storage and distribution of clinical trial materials.

Domestic sales will be the key driver of revenue growth.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

Spanish CRO, Kymos Pharma Services, announced that it has acquired Pharmaprogress, an Italian firm based in Ancona, specializing in contract research and analysis services.

The acquisition boosts Allergan’s CNS R&D pipeline and adds development programs focused on treatment for Alzheimer’s disease.

Shire plans to establish a 550,000-square-foot campus that will focus on innovation in rare diseases and highly specialized conditions.

Saneca Pharma has secured an agreement with Italian pharmaceutical company Menarini Group to deliver controlled-release pellets for one of its products.

ESCMID has organized various activities to promote prudent use of antibiotics in Europe.

The company plans to expand access to its Prevanar 13 vaccine in humanitarian emergency settings.

STEERLife and the University of Mississippi will collaborate on fractional lobe processing research.On Nov, 15, 2016 STEERLife, creator of proprietary continuous processing technology, and the University of Mississippi, announced an agreement for collaborative research using fractional lobe processing. The agreement is for the development of advanced pharmaceutical applications including semisolid formulations for dermal and transdermal applications.

CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.

Neovacs acquired Amegabiotech’s Interferon Alpha manufacturing license for the manufacture of its lead therapeutic candidate.

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.

Research by agency scientists may help speed development of Zika virus vaccines.

Despite some progress, pharmaceutical companies have a long way to go in making their products accessible and affordable, this year's study finds.

Roche launched imCORE, a global network of cancer immunotherapy centers of excellence.

Nine fellows recognized for research ranging from cancer treatment to improved vaccines.

AAPS presents Dale E. Wurster award to Stephen Byrn for his work in the field of solid state chemistry.