The EU industry commissioner has said the scale of pharmaceutical counterfeiting “exceeded our worst fears” and the EPHA has weighed into the debate on the development of the draft directive.
Medidata says the latest addition to its EDC platform, the Rave Safety Gateway, will cut the time it takes to report adverse events during trials and help CROs and their sponsors comply with increasingly stringent reporting rules.
Almac has entered into a partnership with FACIT.org to gain PRO and QoL assessments which it believes will help it recruit patients and generate high quality data for regulatory submissions.
Hermes Biosciences has been acquired by Merrimack Pharmaceuticals in a deal which aims to combine the companies’ drug discovery and delivery platforms to develop cancer treatments.
Teva will continue to use Codexis’ biocatalysis technology for key processing steps in the production of four generic drugs under a revised agreement announced last week.
Preclinical drug testing specialist Absorption Systems has branched out and opened a new surgical lab designed to help pharmaceutical firms assess the safety of biomaterials and medical devices.
Irish CRO Icon has received a US Food and Drug Administration (FDA) warning letter relating to two studies of an antibiotic it conducted between 2004 and 2006.
Dow has joined with Signet Healthcare Partners to form a new independent company which will use the chemical company’s Pfenex protein expression technology to accelerate development.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at PharmaNet, Chiltern and Cardinal Health.
Repeated mandatory inspection of overseas API facilities should be performed to prevent falsified products entering the EU, according to a committee which has published proposed amendments to the draft directive.
India’s Ministry of Health and Family Welfare (MHFW) want to make the collection biometric data from all clinical trial participants standard across the country’s research sector.
inVentiv Health has rolled-out FlightPath, a new bespoke service designed to help pharmaceutical and biotechnology companies chart a clear course to commercial launch.
Watson Pharmaceuticals gained US rights to market a generic version of Lipitor (atorvastatin) in 2011 with the acquisition of non-branded drugmaker Arrow Group late last week.
Synexus has agreed to acquire Clinpharm, giving it access to 10 clinical trial sites in Germany, Austria and Ukraine and increasing its patient population reach in Europe by 100 per cent.
in-PharmaTechnologist presents its latest round up movements in the pharma sector, including CytRx bolstering its manufacturing expertise and KV preparing its management as it strives to resume distribution.
CDMO Haupt Pharma has invested in a combined heat and power unit (CPHU) for its site in Wolfratshausen, Germany, which is now expected to produce 14 per cent less CO2 a year.
PPD is targeting growing demand for contract data analysis with a new biostatistics infrastructure that, it says, offers improved security and reporting.
Pfizer and Protalix have increased the pressure on Genzyme by signing a new accord to commercialise Uplyso (taliglucerase alfa), a potential rival to its Gaucher’s disease treatment Cerezyme, just days after the US biotech resumed production.
Roche has licensed Aegis Therapeutics’ ProTek stabilisation technology, which uses GRAS excipients to prevent aggregation and therefore improve production of peptide and protein drugs.
India-based CRO Ecron Acunova will support its geographic expansion and strengthen its service offering after receiving Series B financing from OrbiMed’s Caduceus Asia Mauritius.
CMO Vetter Pharma has expanded its manufacturing capacity with a new in Illinois, US that it says brings it closer to customers and will allow it to collaborate with clients earlier in the drug development process.
Indian API maker Avon Organics’ share price rocketed 10 per cent on the Bombay exchange yesterday after the US launch of a generic herpes treatment by Ranbaxy Laboratories.
A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Takeda, Aquapharm and Cannabis Science.
Terapio has secured $5m (€3.3m) in funding to develop RLIP76, which is being used to counteract radiation and deliver large molecules across cell membranes, such as genetic material across the BBB.
Leeds University in the UK has unveiled a new £4m (€4.4m) laboratory designed to make small-scale process development “greener, cheaper and more effective.”
Patheon and JLL are to end the legal actions between them by entering into a litigation settlement which establishes a board of directors and limits JLL acquiring additional restricted voting shares before April 27 2012.
US CRO Life Science Research has become a private company with the completion of its acquisition by Lion Holdings, an investment vehicle owner by CEO Andrew Baker.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at West Pharmaceutical Services, Catalent and Kforce Clinical Research.
World Courier has GxP compliant status for its whole distribution network, covering more than 140 offices in 50 countries, which it believes no other business in the sector has achieved on such a large scale.
IQWiG says Pfizer’s refusal to make some data available “hindered” its report on antidepressants and called for EU mandated trial registration and publication rules.
Sanofi-Aventis plans to participate with a Russian state-owned corporation in a project to attract innovative drug manufacturers to the country, using its insulin facility as a pilot initiative.
Unilife Medical Solutions has filed US patents for Unifill Select, which it claims is the first ready-to-fill (RTF) syringe specifically designed for vaccine delivery.
Infosys Technologies has helped CRO Quantum Solutions India (QSI) implement Microsoft Dynamics NAV 2009 which will allow data management, process harmonisation and reduce delays.
Indian drugmaker Ranbaxy Laboratories has withdrawn stocks of its acne drug Sotret in the US for the second time this year after some tablets were found to be out of specification.
Synexus has recruited more than 2,000 children in three months for a Phase III rotavirus vaccine study, which it believes validates its methods and demonstrates they are particularly effective in late stage vaccine trials.
Amcor has indicated it would be prepared to sell a flexible packaging business to address European Union anti-trust fears over its proposed takeover of Alcan.
The recent wave of M&A will lead to manufacturing over-capacity at pharma companies but only a small number of these sites will be sold to CMOs, in part because of the facilities’ suboptimal locations, according to a report.
Sinovac Biotech has formed a joint venture which will give it cost effective manufacturing capacity for 20m does of live attenuated vaccines and 20m doses of vero cell cultured vaccines a year.
The market for contract manufacturing organisations (CMO) will be worth $33.7bn (€22.4bn) by 2014, according to a report which says developing biologics capabilities is a key imperative for growth.
Novartis says its new cell culture plant in Holly Springs, North Carolina could begin making its flu vaccine boosting MF59 adjuvant as early as next month if approved by US regulators.
The USP has clarified its proposed revision to the labelling of injectable drug vials which states that ferrules and cap overseals can only have markings intended to prevent an imminent life-threatening situation.
