The shipping requirements of drugs means the TSA’s new law poses unique problems to the pharma industry, according to DHL, but experience of tight regulations should help companies achieve compliance.
Amcor has dismissed claims that it should pay hundreds of millions of dollars in damages over allegations it took part in a packaging price fixing cartel.
CRO NexMed says new data from preclinical trials show that its NexACT delivery technology can act as a sustained release “depot” for drugs like insulin and taxol.
The Botswanan government is seeking to initiate local pharma manufacturing, which would lower drug prices, by entering into public-private partnerships (PPP), according to a report by F&S.
PPD and Southern Research are collaborating to strengthen their pandemic and seasonal influenza development services by working together on client bids and projects.
CEO Steffen Mittwich updates in-PharmaTechnologist on Atacama Labs' pneumatic dry granulation (PDG) API processing tech, its deal with German CMO Excella and future development plans.
Outsourcing to Asia is changing “from a tactical to a strategic imperative” as a result of the region gaining the capabilities needed to perform work high up the biopharma value chain, according to Quintiles.
Ireland must become an R&D hub as well as a drug manufacturing destination to prosper in the increasingly competitive global pharmaceutical market, says industry body PharmaChemical Ireland (PCI).
Indian CRO GVK Biosciences hopes new clinical pharmacology unit in Ahmedabad will help boost patient recruitment to meet growing demand for clinical trials in the region.
Prosonix’ new UMAX particle engineering technology is set to “revolutionise” the field of respiratory medicines, according to company CEO David Hipkiss.
Quintiles has relocated its global central laboratory in Japan to meet rising demand from the local market and US and European pharmas keen to include the country in their clinical trial network.
Compugen has developed a computer-based, in silico system which can assist drug delivery research by identifying peptides that have the potential to penetrate cell membranes.
US drugmaker Genzyme has detected an impurity in one vial of the Gaucher’s disease drug Cerezyme produced at its manufacturing facility in Waterford, Ireland.
US Food and Drug Administration (FDA) request for more Afrezza data is not safety related and will not require new clinical trials, says developer MannKind.
Patheon attributes Q1 loss to charges and plant closure costs and says there has been “an encouraging increase in new sales activity” in calendar 2010.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Pacific Biomarkers, Halloran Consulting Group and Venn Life Sciences.
GSK, Genentech, BIO and PDA have stated that it is “unnecessarily burdensome” for pandemic production plans to conform to parts of 21 CFR and requested that the FDA revises its draft guidance.
Indian CMO Bilcare says need to test new drugs in diverse patient groups drove expansion of its cold chain clinical trial supply packaging and storage facility in Crickhowell, Wales.
INC Research is partnering with invivodata to add ePRO to its offering, selecting the eClinical firm over its competitors in part because it understands the “aggressive” approach the CRO takes.
Australia-based CRO TetraQ is doubling throughput of trial samples, resulting in a 30 per cent time saving for clients, by installing a Spark Symbiosis system at its site in Brisbane.
Merck & Co has joined a coalition to build a vaccine facility which is capable of simultaneously manufacturing multiple products and can quickly switch in response to a crisis.
The Chinese government is supporting a $100m (€73m) project to build a contract biologics production facility in Beijing, which, by some measures, would be the largest in Asia.
E Research Technology (ERT) launches Centralised Cardiac Safety 2.0 (CCS 2.0) service for ECG data and says approach improves efficiency, cuts costs and helps sponsors reach database lock quicker than distributed model.
Stason Pharmaceuticals’ subsidiary Standard Chem and Pharm will act as primary distributor for the Unitract 1ml safety syringe in China, Japan and Taiwan under a five-year new deal with US delivery device maker Unilife.
DNA sequencing specialist Genewiz has added gene synthesis to its service portfolio, providing researchers with a time- and cost-saving alternative to techniques such as molecular cloning and protein engineering.
Kendle has implemented a centralised biostatistics platform which will “create significant time savings” by improving global access to clinical trial data, according to the company.
Japan-based CRO Mitsubishi Chemical Medience (MCM) has purchased a range of Provantis preclinical software modules from Instem to manage study processes and collect data.
An adaptive approach to both the design and operation of a clinical trial can boost efficiency, reduce timelines and cut costs says Health Decisions' CEO Michael Rosenberg.
Cambridge Major Laboratories (CML), Avantium, Xcelience and Beckloff have formed a consortium to offer tailored, client-focused CMC packages which are particularly suited to atypical compounds.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at PharmaNet, Albemarle, VGXI and Ocimum Biosolutions.
Synthon has completed the acquisition of Mexico-based Nafar Laboratories, adding to its presence in Latin America which includes recent purchases in Chile and Argentina.
WuXi PharmaTech posted an operating profit of $52m (€38m) in 2009 and is optimistic about 2010, when it will make investments in laboratory services and large-scale manufacturing to drive growth in coming years.
Wacker Chemie AG has expanded its biologics production facility, adding GMP manufacturing capacity and a process development building in response to customer demand.
Drug firms continue to make basic errors in their electronic submissions according to French regulatory group the AFSSAPS, which said recently that it returns half the NeeS dossiers it receives as they do not meet basic validation standards.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Agilent Technologies, iBio, Sanofi Aventis and Q Chip.
Xcellerex is using its single use bioreactor system, FlexFactory, to develop a novel manufacturing process for Humacyte’s regenerative medicine candidate.
OmniComm has launched a comprehensive Phase I eClinical tool, which it believes is the first of its kind, to help users make cost and time savings by improving efficiencies.
Indian generic drugmaker Aurobindo Pharma officially launched its CRAMS unit AuroSource last week, also unveiling plans for an R&D facility in Pashamylaram near Hyderabad, India.
Payne Security has acquired BP Secure Solutions, adding the UK firm's roster of adhesive security labelling technologies to its drug industry offering.
Kendle is setting up a facility in a special economic zone (SEZ) in India which will provide clinical support services and be able to rapidly increase staffing in response to spikes in demand.
Inovio Biomedical has developed a hand-held, cordless electroporation device, Cellectra-SP, which it believes is well suited to administering DNA vaccines in mass immunization programmes.
German contract manufacturing organisation (CMO) Excella will provide pneumatic dry granulation (PDG) tablet making services through a new partnership with Finnish specialty pharmaceutical firm Atacama Labs.
Trial planning can be a big challenge for small pharmas says US software group ClearTrial, which has launched a brand new contract study costing and optimisation service (SCOS).
South Africa-based Aspen Pharma is to sell its Brazilian oral solid dosage form manufacturing facility to Strides Arcolab after posting a 15 per cent drop in revenues from Latin America.
Fujifilm has introduced an anti-counterfeiting label, called ForgeGuard, which it claims is the first product with full colour images and text that can be checked using a viewing device.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Cytovance Biologics, PharmaNet and Cook Pharmica.
