US CRO Quintiles expands PI3K assay offering, predicting increased drug industry demand for expertise in key survival pathway in era of personalised cancer treatments.
The Consortium for the Advancement of Patient Safety (CAPS) says research shows that USP plans to restrict printing on pharmaceutical vial ferrules and caps are “ambiguous and vague.”
Chiltern’s early phase unit in Dundee, Scotland has achieved supplementary accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA).
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Genzyme adding more manufacturing experience and resignations at Uluru and Par.
Nampak Europe is to invest €4.5m ($5.4m) in a new purpose-built factory to replace its Wolfen facility in a move to reduce product costs in the northern European arm of the business.
Massachusetts-based Pharmalucence is constructing a 70,000 sq ft production facility to boost the contract manufacturing capacity it can offer local biotechs.
Investors are funding the creation of a RUB1.6bn ($52m), 10,000 sq m preclinical Russian CRO to fill the gap in the nation’s development chain and undercut western prices by 40 per cent.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Harlan, OmniComm, Cedra, OmniComm and Clearstone.
American chemicals maker Cambrex has announced its active pharmaceutical ingredient (API) manufacturing facility has completed a successful FDA inspection.
X-ray transparency and added durability are benefits of a new conveyor belt that helps improve performance for contaminant detection in glass containers on food and pharmaceutical lines, said Mettler Toledo Safeline.
Malaysia is keen to attract Indian biopharm companies and is offering incentives and infrastructure to encourage firms to establish manufacturing operations, according to local media reports.
The USP is strengthening links with Eastern Europe and Russia by agreeing to share quality standards with Ukraine and offering training courses in Moscow.
US-based contract research organisation (CRO) Novella Clinical has acquired Prologue Research to enhance its offering of oncology clinical trial services.
Celerion has implemented a hybrid ECG core lab across its Phase I network to help clients get through this early developmental stage “much cheaper and much faster”.
Increased focus on post-market safety and value has resulted in CROs handling more Phase IV work, according to a PharmaNet EVP, and this trend may continue as regulators seek real world evidence.
India-based Surya Pharmaceuticals is planning to raise Rs 500 crore ($100m) to fund construction of an active pharmaceutical ingredient (API) production plant, according to local media reports.
Indian-based drug makers continue to come under intense scrutiny by the US Food and Drug Administration (FDA) as the regulatory body issues warnings to healthcare professionals not to use certain brands of antibiotics due to potential contamination.
CMOs are set to gain biologics business and capacity in the coming years as large pharma increasingly outsources to cut costs and speed development, according to a report published today.
Clearstone Central Laboratories is to wind down or sell its centralised cardiac services (CCS) business because significant investment would be required to remain competitive.
ISP Pharmaceuticals has expanded its extrusion spheronisation offering with the installation of new dedicated technology at its laboratory in Sao Paulo, Brazil.
Ampac Flexibles continues to utilise its High-Speed (HS) Laminate technology by launching its laminate films – a product, which the makers claim will heat seal at temperatures 40 degrees lower than standard laminate materials.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Pfizer and AstraZeneca naming R&D leaders and appointments at APV and Lonza.
Siegfried is to supply at least 60 per cent of Jazz Pharmaceutical’s global requirement for sodium oxybate, the active pharmaceutical ingredient (API) in Xyrem.
Claris has initiated a recall of three antibiotics it manufactures, which are also sold by Sagent, Pfizer and West-Ward, after the FDA warned of contamination.
The EMA has published its thoughts on monitoring overseas trials and will seek to establish an international network of regulators to develop and implement a robust oversight framework.
Hungary-based Ubichem Research has gained approval to supply cGMP radiolabelled APIs in the European Union (EU), positioning it to benefit from increased demand.
A trio of robots that can cope with the demands of vaccine handling and its packaging is ushering in new automation know how as part of a growing army of pharmaceutical production robotics.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Girindus, Lonza, Idis and Flagship Biosciences.
Lanxess has signalled its intentions for the future by investing €35m ($43m) to expand its German Basic Chemicals business unit in a move that is set to make the firm one of Europe’s biggest active pharmaceutical ingredients (API) producers.
The business process outsourcing (BPO) unit of Indian IT services firm Mahindra Satyam has had its contract with GlaxoSmithKline (GSK) renewed for another five years.
The EMA’s EudraVigilance post-authorisation module (EVPM) speeds detection of adverse drug reactions in some cases, according to a new study published in the journal Drug Safety
DPT Laboratories has added bulk production and packaging capacity at its liquid and semi-solids plant in San Antonio, Texas in a continuation of its recent manufacturing reorganisation.
More than 50 per cent of large pharma keep all pharmacovigilance in-house but among smaller firms, and even some big businesses, outsourcing is considerable, according to a new report.
Indian’s Biocon will supply US biopharma Optimer Pharmaceuticals with the API fidaxmicin for its candidate Clostridium difficile infection (CDI) drug OPT-80 under a new long-term contract.
AMRI is reducing its US workforce 10 per cent and halting operations in one R&D lab at its facility in Rensselaer, New York as “softness” in the domestic market continues beyond its expectations.
Adcock Ingram recorded an 11 per cent rise in profit in the first half of 2010 and is looking to continue this upwards trend through manufacturing expansions, plus local and overseas acquisitions.
US biotech Genzyme will pay $175m and cease some manufacturing operations at its facility in Allston, Massachusetts under final terms of Food and Drug Administration (FDA) consent decree.
Sepha has introduced EZ Blister II to meet rising demand from India, China and South America for an affordable, mobile blister packaging machine for clinical trial use.
The Indian Government plans to help medium sized pharmaceutical firms meet World Health Organisation (WHO) manufacturing plant standards with a new subsidy scheme.
