US drug firms’ qualification of overseas API vendors will be subject to increased FDA scrutiny in the coming years according to a new industry report by analysts Hogan & Hartson (H&H).
A new 9,500 unit per hour sterilised syringe filler was a highlight of Bosch Packaging Technology’s busy programme of machine launches at Achema 2009 in Frankfurt, Germany this week.
eClinical provider Datatrak has posted flat revenues in Q1 but its operating loss was badly affected by the severance packages of two executive officers.
PDI posted a larger operating loss in Q1 2009 than in the previous year, with the company blaming the decline on the expiration, termination and postponement of contracts.
CRO Encorium has unveiled plans to sell both its US business and its Finnish subsidiary Encorium Oy just weeks after posting a gloomy set of Q1 financials dominated by a 15 per cent drop in net revenues.
Sanofi-aventis is has made its largest ever investment in its vaccine capacity, using €350m ($479m) to construct a dengue fever vaccine manufacturing plant in France.
ExcellGene’s OrbShake 250L mammalian cell culture bioreactor has equalled biomass productivity and oxygenation levels previously only achieved by traditional stirred tank systems.
Sanofi-Aventis has expanded its collaboration with Pilgrims to include its Dagenham, UK facility, which will now be guarded by the security services company.
GlaxoSmithKline (GSK) is to take a 16 per cent stake in Aspen in exchange for a manufacturing facility and eight medicines, building on the companies’ relationship and the big pharma’s profile in Africa.
A new $60m (€43m) manufacturing suite is operational at the South Carolina, US plant where Roche makes APIs for some of its leading products, including for its anti-flu drug Tamiflu (oseltamivir).
Rottendorf Pharma has completed its development and upscaling pilot plant, which will complement its other sites that provide manufacturing and packaging services.
Baxter International says Pfizer supplied the bulk API used in a batch of Heparin linked to two patient deaths in Delaware, US last week, amid concerns of a repeat of last year’s contamination scandal.
Cambridge Consultants has developed its ‘connected patient’ technology, which creates a communication network between drug delivery devices and healthcare professionals to increase compliance.
US non-clinical contract research firm Wil Research Laboratories has reduced its 700 strong workforce by 4 per cent, citing a drop in business due to the global economic downturn as the basis for the cuts.
UK CMO SCM Pharma, which specialises in the handling of volatile materials, has won a contract to fill and finish a radiolabelled oncology drug on behalf of European drug major Sanofi Aventis.
Italian machining specialist Marchesini’s claims its new 150 carton per minute Unica monobloc packaging system offers syringe makers greater packaging flexibility, improved cleaning access and quicker change over.
BioClinica is continuing its expansion in eClinical by proposing to acquire etrials, which underwent significant restructuring in 2008 but still suffered repeated quarterly losses.
The FDA plans to increase field tests in imported drugs by over 100 per cent and has requested a 19 per cent rise in its budget for 2010 to enable it to achieve this and other targets.
A new ready-to-use WFI prefilled syringe for the reconstitution of lyophilised drugs is likely to win fans among producers of high-value biopharma drugs according to West Pharmaceutical Services’s VP of European marketing, Mike Schaefers.
Agilent has completed the second expansion of its nucleic acid active pharmaceutical ingredient (API) manufacturing facility, which is intended to meet rising demand for oligonucleotide-based drugs.
UK software group Cisiv has unveiled a web-based EDC platform, Baseline Plus, which is specifically tailored to meet the demands of post market trials.
Definitive FDA guidance on adaptive trials cannot come soon enough for the pharmaceutical and biotech sectors, according to Perceptive Informatics (PI).
US chemistry firm PharmaTek Laboratories has a green light to start making high potency APIs and cytotoxics at its facility in California after meeting strict safety and control rules that govern their production.
Medica Packaging is upgrading its label inspection capabilities through the installation of three Surfscan Technologies systems, which should eliminate customer returns by detecting defects.
SurModics has completed the three year Phase I trial of I-vation TA (triamcinolone acetonide), which uses a novel drug delivery system capable of sustained ocular release of a therapeutic.
Drug delivery specialist Hospira has set up a “biologics clock” that counts the amount spent on cell culture-derived medications in the US in a bid to highlight the potential savings greater use of generics could provide.
AstraZeneca (AZ) has become the latest company to enter into a research collaboration with Jubilant, with the companies initially focusing on delivering preclinical candidates in the neuroscience area.
CRO Eurotrials has brought in US business consultant AmeriStart to publicise and sell its trial services to pharmaceutical and biotech firms in North America.
Copley Scientific is expanding its range of nebuliser testing equipment by launching its NGI Cooler, which has been developed in light of suggested revisions to aerosol monographs on both sides of the Atlantic.
Creative thinking is required by biotechs if they are to stay afloat despite the lack of funding, according to a report by Ernst & Young, and this could reshape the landscape of the industry.
Charles River Laboratories (CRL) has bucked the CRO sector trend and reaffirmed its forecasts for 2009, citing an improved order book and better pricing as the reasons for its relative optimism.
Venezuela has inaugurated a state funded pharmaceutical manufacturing facility and allocated resources for a new complex as part of the nation’s attempts to provide subsidized drugs to citizens.
French drug major Sanofi Aventis has unveiled plans for a €200m ($268m) biotechnology investment at its manufacturing facility in Vitry-sur-Seine near Paris, under its collaborative Biolaunch project.
Pharmafreight and Kryotrans have teamed up to offer a one-way, temperature-controlled shipping service that they claim will help pharmaceutical exporters cut costs and boost efficiency.
Perceptive Informatics has expanded its offering for trials involving Alzheimer's disease with a new medical imaging method, which it claims produces higher quality, reproducible and regulatory compliant assessments.
Axentis Pharma has received orphan drug designation (ODD) in the US for its cystic fibrosis treatment, which uses liposomes to deliver prolonged high-concentrations of a therapeutic to the infected area.
German industrial phosphate maker Budenheim has been certified to produce calcium phosphates as pharmaceutical excipients under ICH Q7A GMP guidelines.
Greek authorities have banned the export of the anti-virals Relenza and Tamiflu to prevent the country’s stockpile being sold off through parallel trade as global demand for the drugs increases on concerns about a H1N1 influenza pandemic.
Outsourcing-Pharma provides its latest round up of movements in the pharmaceutical outsourcing sector, including appointments at Cardiocore and HUNT Biosciences.
Bemis has confirmed that “confidential efforts are ongoing” in its attempt to acquire Alcan Packaging, which has been up for sale since mining giant Rio Tinto bought its parent company.
Suspicious spikes in the trading of Schering-Plough shares prior to its merger with Merck & Co are being investigating by the SEC, according to media reports.
Althea Technologies’ biologics and injectables contract development, manufacturing and testing facility in San Diego, US is open for business, bringing to an end the firm’s two year campaign to expand capacity.
Two recombinant human albumins made by Novozymes' biopharma division have become the first to comply with the USP-NF's recently revised excipient monograph.
US contract research organisation (CRO) Encorium has reported $2m in new and repeat business deals on the same day it posted gloomy Q4 figures and cited the "drop in demand" refrain heard across the trial sector.
US strategic consultants CourtSquareGroup say that while optimisation of operations is key for the drug industry, companies risk losing the business knowledge required to undertake such action in the scramble to cut costs in the global downturn.