CRO PFC Pharma Focus is using a HMO database to provide feasibility information before a clinical trial starts, reducing costs, risks and developmental timelines.
US CRO Quintiles expands PI3K assay offering, predicting increased drug industry demand for expertise in key survival pathway in era of personalised cancer treatments.
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.
An anti-counterfeiting pilot project in Nigeria, which uses a mobile authentication service (MAS) to validate genuine medication, has completed a 100-day pilot phase. Preliminary results suggest the scheme is well on the way to becoming an effective defence...
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.
Indian API manufacturer Shasun Chemicals and Drugs turned a previous loss into profit for Q4 of this year as it seeks to make a dent in the biosimilar manufacturing sector.
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.
ISP Pharmaceuticals has expanded its extrusion spheronisation offering with the installation of new dedicated technology at its laboratory in Sao Paulo, Brazil.
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.
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.
Contract research organisation (CRO) Quintiles Transnational has boosted its UK marketing teams through a deal with Nycomed but is planning cutbacks at US operations in RTP.
US CMO Contract Pharmaceuticals (CPL) to close Buffalo plant by the end of 2011 on weak demand it attributes to pharmaceutical industry outsourcing cuts in downturn.
Invida has acquired a stake in Indonesia-based MUGI, giving it the local manufacturing presence needed to offer partners access to “a vast untapped market”.
The US FDA should change its disclosure policy relating to manufacturing site inspections according to new draft recommendations by the Department of Health and Human Services (HHS) Transparency taskforce.
Contract research organisation (CRO) Chiltern says new Australia and Singapore offices are a natural progression for its contract research business in the Asia-Pacific region.
An increase in demand for rayon fabric in China has led to higher prices for microcrystalline cellulose, an excipient for pharmaceuticals and a stabilizer for foods, drinks and personal care products.
CRO Quintiles says Southern California Permanente Medical Group (SCPMG) partnership will improve patient recruitment and, ultimately, accelerate the drug development process.
Encorium has posted a $1.9m (€1.6m) operating loss in the first quarter, with contract cancellations and reduced new business driving net revenues down by almost 34 per cent.
India and Thailand have requested the WHO ends its involvement with IMPACT, which the countries believe has conflicts of interest, and begin a programme focused on quality, safety and efficacy.
Pfizer plans to close eight manufacturing sites and reduce operations at a further six by the end of 2015, leading to 6,000 job losses, as part of its reorganisation after acquiring Wyeth.
Operating income at Medidata grew in the first quarter, underpinned by record bookings by contract research organisations (CRO) and rising revenues from Asia Pacific.
Parexel has opened two offices in China, expanding its presence in Asia Pacific to 17 sites, as part of efforts to provide cheaper, faster drug development services.
