News

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

Johnson&Johnson will open a network of partnering offices across the UK.

GlaxoSmithKline plans to expand its facilities in Ware and Worthing in the United Kingdom and will build a new facility for manufacturing innovation.

Roche and Prothena sign deal worth up to $600 million to develop and commercialize antibodies that target alpha-synuclein.

Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

Octapharma and Pfizer form an agreement for the future marketing and commercialization of human prothrombin complex concentrate.

GSK forms the Oncology Clinical and Translational Consortium, a scientific research network comprised of six international cancer centers.

OGD is under pressure to improve review operations.

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

LSNE appoints Shawn Cain as COO, a new position within the company.

EMA revises its polices on fee reductions for orphan drugs for 2014.

TxCell has received manufacturing accreditation status of its cell-therapy production site in Besancon, France, from the French National Agency for Drug Safety (ANSM).

SGS Life Science Services announced that its bioanalytical laboratory in Poitiers, France has received GMP certification, following approval from ANSM.

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

The Indiana Biosciences Research Institute will accelerate collaboration and focus on human-health solutions.

Additional companies join Merck KGaA and Neviah Genomics in the Israel BioIncubator.

Almac releases an enhanced third-party logistics customer billing application.

GSK and Amicus Therapeutics revise Fabry agreement entered into in July 2012.

GlaxoSmithKline plans to invest nearly $41 million to expand its operations at its facility in Montrose, the United Kingdom.

Thermo Fisher must divest of cell culture media and sera lines, and other businesses, in purchase of Life Technologies.

Catalent opens clinical-trial supply facility in Shanghai, China.

Mylan and the Indian biopharmaceutical company Biocon receive approval for a biosimilar version of trastuzumab in India. Also, Mylan and Teva reach settlement on Copaxone in the EU.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

Merck KGaA plans to build a new biomanufacturing facility in Nantong, China.

Catalent has signed a product development agreement with immunology company Pure MHC (major histocompatibility complex), which specializes in MHC-based diagnostics and therapeutics.

Phase I/II study to evaluate treatment of patients with melanoma using Pfizer’s palbociclib and GSK’s trametinib.