Butterworth Laboratories Ltd has secured an additional facility in Hampton, Middlesex as it aims to increase capacity by 60% over the next three years.
The inability to identify the best clinical trial sites is a big problem – and one of the major challenges negatively affecting drug pricing and sponsors, says CEO.
WuXi AppTec’s LabNetwork is collaborating with Reaxys in order to simplify customer’s purchasing decisions and expand exposure to the WuXi eCommerce platform.
Fresenius Kabi wants Wockhardt to change a BSE filing it says does not accurately reflect its role in the production of a Zosyn generic recently approved in the US.
Pfizer CentreOne has recently expanded its fill-finish and highly potent solid oral dose service offerings at two of its contract manufacturing facilities as it aims to fulfill a promise to grow its capabilities.
INC Research and Medidata are among those supporting the Leukemia & Lymphoma Society’s (LLS) novel, multi-arm clinical trial for acute myeloid leukemia (AML).
The National Institutes of Health (NIH) has reached a milestone in its goal of accelerating multisite clinical studies through a single institutional review board (IRB) model.
As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.
The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.
Alexion Pharmaceuticals will use the LNP delivery licensed from Arbutus Biopharma as part of its messenger RNA therapeutics development partnership with Moderna Therapeutics.
Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.
Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive disadvantage.
Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.
Imprimis Pharmaceuticals says it is evaluating pursuing New Drug Application (NDA) status for some of its product reformulations through the US FDA 505(b)(2) development pathway.
Marken has secured two new operating licenses in Argentina, allowing it to provide a full range of logistics services to the country’s clinical trial market.
Solvias has struck a deal with Germany’s Merck to supply a monocyte activation test (MAT) kit for detecting pyrogens in pharmaceutical raw ingredients.
The US FDA has issued AstraZeneca with a second CRL for its hyperkalaemia candidate Zs-9 after finding problems at a Texas facility operated by subsidiary Zs Pharma.
The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
Envigo is developing new In vitro tests in advance of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) recommendations expected at the end of the year.
DHL Global Forwarding plans to certify seven US stations in the Americas throughout 2017 with the remaining global stations slated for certification by the end of the second quarter.
Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.
update - Epipen manufacturer Meridian Medical Technologies completes investigation
Fred Hutchinson Cancer Research Center will use Origin Sciences’ novel mucosal sampling device, OriCol, for sample collection as part of a Phase I HIV study.
The US Justice Department has announced Charles River Laboratories International Inc. will pay the US government $1.8m to settle claims that it violated the False Claims Act.
The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.
