CRO PPD (Pharmaceutical Product Development) is bolstering its bioassay and bioanalytical services in both the US and Brazil, respectively, in preparation for more niche biologic and biosimilar developments.
The US FDA has waived normal pre-approval inspection requirements and cleared CMO Cook Pharmica to make an injectable drug that is currently in short supply.
Drugmakers Merck & Co and Eisai have both substantially cut internal data management costs through two unique off-shoring operations in China and India, respectively.
Drug solubility science, technology and solutions will take centre stage at “The Bioavailability Challenge” a free to attend online event in-Pharmatechnologist.com is hosting on Wednesday, March 20.
Pennsylvania-based Calvert Laboratories and Particle Sciences are combining their expertise in preclinical drug development to provide clients with more streamlined options.
In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Glide, BASF and Pall.
Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry, including news from Catalent, Dow and Agere Pharmaceuticals.
The US FDA’s ability to inspect facilities, trial sites, and deal with all but its most pressing priorities will be restricted by mandatory government spending cuts according to the Alliance for a Stronger FDA.
Merck Serono says “fast progress” in its restructure programme helped double its net savings guidance for 2012 though headcount dropped by almost 2,000 with more cuts to come.
WuXi PharmaTech has expanded its partnership with Open Monoclonal Technology (OMT) to use its transgenic rats and mice in China and other Asian countries.
A new partnership between a niche cancer drug discovery company and biotech powerhouse Celgene could pave the way for the future of cancer drug discovery and delivery.
Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.
Welcome to Outsourcing-Pharma.com’s round-up of CRO focused partnerships and collaborations including news from Particle Science and Agility Clinical Partners.
Ajinomoto says its flexible approach to tech licensing differs from rivals who are more focused on locking customers into manufacturing services contracts.
As anticipation swells over how the biosimilar market will shape up in the US, some contract biologic manufacturing executives don’t seem to think the size of the market is worth all of the hype yet.
SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.
Contract drug developer Particle Sciences has recently chosen China-based CRO Crystal Pharmatech to analyse the bioavailability and material properties of its developing compounds, and the collaboration may turn into a joint venture.
The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.
Good ideas in drug delivery will continue to attract investment though the increasing cost of clinical trials does pose a difficulty according to MIT Professor Robert Langer.
Ireland-based CRO Icon unveiled higher than expected revenue and backlog increases in 2012 when compared to 2011, and the company expects even stronger results in 2013.
Pantarhei Bioscience has sold in Estetra, its oral contraceptive development JV, to partner Uteron Pharma and will use the proceeds to fund further development.
Biopharmaceutical CMOs have seen their business slowly shrink as companies seek less volume and smaller batches, but outsourcing is expected to increase over the next three years.
West Pharmaceuticals says it is still intent on shifting to proprietary products following results from its packaging and contract manufacturing businesses.
The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.
CMO ProBioGen says its GlymaxX ADCC antibody enhancement technology can be adapted to any biomanufacturing cell line and will attract both Big and Small Pharma.
Quintiles painted a rosy picture of the CRO sector in its much anticipated IPO, predicting that biopharma R&D spending will increase and demand for outsourced research will grow.
PPD has expanded its central lab testing services at its Brussels and Singapore labs and will offer additional services in microbiology, peripheral blood mononuclear cell and molecular pathology services.
Protalix Biotherapeutics is attempting to use its US FDA-approved Gaucher's disease treatment as a proof of concept and springboard for its plant-based cell manufacturing technology.
