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.

Biopharma proponents argue for FDA resources, Cures legislation, and science-based drug regulation.

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.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

NIH researchers developed a test to identify existing drugs that might be able to combat drug-resistant bacteria.

The new Boston laboratory offers advanced analytical testing services.

The agreement allows Bristol-Myers Squibb exclusive license to manufacture and commercialize Nitto Denko Corporation’s NASH treatment.

The Broad Institute and IBM Watson Health will collaborate on a $50 million project to study how cancers become resistant to therapies.