http://www.ptemag.com/pharmtecheurope A publication featuring peer-reviewed technical articles on all aspects of pharmaceutical and biopharmaceutical manufacture. Subjects include solid dosage, drug delivery, packaging, raw materials, clean rooms and IT applications, supported by regulatory columns from Brussels and Washington. Information on products and literature used in drug manufacturing, as well as industry news, are also provided. 2009-07-03T23:25:05Z http://www.ptemag.com/pharmtecheurope/Latest+News/UK-strengthens-medicines-supply-chain/ArticleStandard/Article/detail/607307?ref=25 The UK's Medicines and Healthcare Regulatory Agency (MHRA) has published the outcome of a consultation on measures to strengthen the country's medicines supply chain. 2009-07-03T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607307null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/New-EU-committee-leaves-member-states-out-in-the-c/ArticleStandard/Article/detail/607306?ref=25 Although all Member States are in favouring of tightening pharmacovigilance rules, which element of the 'pharma package' is causing dispute? 2009-07-03T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607306null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/FTC-issues-report-on-authorized-generics/ArticleStandard/Article/detail/607844?ref=25 The Federal Trade Commission (FTC) last week issued an interim report that examined the effects of authorized generics on competition in the prescription drug market. 2009-07-03T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607844null HTML http://www.ptemag.com/pharmtecheurope/Technology-approaches-to-quality-management/ArticleStandard/Article/detail/608680?ref=25 Sparta's TrackWise 2009-07-03T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/608680null PDF http://www.ptemag.com/pharmtecheurope/Latest+News/Rheumatoid-arthritis-treatment-gets-EU-thumbs-up/ArticleStandard/Article/detail/607310?ref=25 The Committee for Medicinal Products for Human Use (CHMP) of the EMEA has recommended that the EC grants a marketing authorization for Belgium based-UCB's Cimzia, in combination with methotrexate, for the treatment of rheumatoid arthritis (RA). 2009-07-03T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607310null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Artificial-liver-aids-drug-testing/ArticleStandard/Article/detail/607308?ref=25 Could artificial organs help replace animals experiments? Researchers at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB (Germany) believe so; they have developed an artificial liver that they believe will offer greater security for pharma companies and shorten the path to new drugs. 2009-07-03T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607308null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/European-Knowledge-Centre-opened-in-the-UK/ArticleStandard/Article/detail/607309?ref=25 Eisai (Japan) has opened its new European Knowledge Centre in Hertfordshire (UK) after investing approximately 117 million euro in the region to help develop new medicines for Alzheimer's Disease, Parkinson's Disease and epilepsy, as well as new treatments for cancer. 2009-07-03T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607309null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Improving-asthma-treatments/ArticleStandard/Article/detail/608490?ref=25 Better asthma treatments are hoped to arise from a collaboration between Domainex Ltd, St George?s University of London and the University of Manchester (all UK). 2009-07-02T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/608490null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/USP-collaborates-with-Asian-authorities/ArticleStandard/Article/detail/607843?ref=25 The US Pharmacopeial (USP) Convention and the Vietnamese Pharmacopoeia Commission (VPC) have signed a memorandum of understanding (MOU) that will help ensure the safety of Vietnamese medicines. 2009-07-02T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607843null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Is-EU-and-US-drug-approval-process-integration-a-n/ArticleStandard/Article/detail/603357?ref=25 Pharmaceutical Technology Europe interviews Sylvia M. Findlay, Programme Leader at Frost & Sullivan. The company has recently released a report entitled Drug Approval Process in Europe — An Outlook and believes that integration of the EU and US drug approval process is a necessity. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/603357null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/A-special-process/ArticleStandard/Article/detail/604658?ref=25 Pharmaceutical Technology Europe interviews the Managing director of The Specials Laboratory, a leading manufacturer of unlicensed medicines in the UK. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/604658null HTML http://www.ptemag.com/pharmtecheurope/Spotlight/EU-and-US-unite-against-rare-diseases/ArticleStandard/Article/detail/605697?ref=25 Rare diseases represent an important area of unmet medical need. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605697null XML http://www.ptemag.com/pharmtecheurope/Manufacturing+%26+Processing/Nanotechnology-the-next-silver-bullet/ArticleStandard/Article/detail/605695?ref=25 A number of commentators during the past few years have speculated that nanotechnology is the wave of the future in biotech and pharma. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605695/Fisher_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Talking+Point/Thinking-of-theranostics/ArticleStandard/Article/detail/605706?ref=25 Are manufacturers ready to deal with the economic and logistical challenges that accompany tailored therapeutics? 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605706null XML http://www.ptemag.com/pharmtecheurope/Analytical/Dynamic-avalanching-accurately-assesses-flowabilit/ArticleStandard/Article/detail/607093?ref=25 Cefaclor is a β-lactam cephalosporin antibiotic that has a wide particle size distribution. Because of the nonporous nature of the material, the specific surface area value accounts for a significant amount of fine particles possibly present in the samples under analysis. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607093/Bonfichi_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Latest+News/US-Marshalls-seize-Caracos-drug-products/ArticleStandard/Article/detail/607842?ref=25 On 25 June, US Marshalls seized all drug products and ingredients at three facilities of Caraco Pharmaceutical Laboratories: Detroit, Farmington Hills and Wixom (MI, USA) Michigan. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607842null HTML http://www.ptemag.com/pharmtecheurope/News/News/ArticleStandard/Article/detail/605696?ref=25 A round up of news from across the globe. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605696null XML http://www.ptemag.com/pharmtecheurope/Biopharmaceuticals/Expression-systems-royalties-battle/ArticleStandard/Article/detail/607154?ref=25 Biopharmaceutical companies generally try to avoid paying royalties on novel technologies, including novel expression systems, in part because of the inability to predict revenue flow after a product is commercialized. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607154/BioArticle_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Human-error-costs-industry-billions/ArticleStandard/Article/detail/605700?ref=25 One of the greatest risks to the success of a business is human error caused by employees' misunderstanding of key aspects of their job roles, and this risk is commonly overlooked or underestimated. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605700null XML http://www.ptemag.com/pharmtecheurope/Information+Technology/Pharmas-Facebook/ArticleStandard/Article/detail/605698?ref=25 Social media is big news. From Facebook to Twitter, individuals are embracing the opportunity to participate in online publishing at an unprecedented rate. Communities of users interact globally, minutetominute within huge databases of content that they themselves create. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605698/LinkedIn_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Outsourcing/SCMs-secrets/ArticleStandard/Article/detail/604224?ref=25 Shirley Dann, Managing Director at SCM Pharma (UK) talks about outsourcing and QbD, and explains why CMOs must focus on what they do well to avoid being left behind. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/604224null HTML http://www.ptemag.com/pharmtecheurope/Regulatory/Are-we-moving-towards-global-patenting/ArticleStandard/Article/detail/607156?ref=25 Patents are an important tool for protecting innovative products, uses or processes intended for commercialization. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607156/Roberts_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Outsourcing/Penny-wise-pound-foolish/ArticleStandard/Article/detail/605694?ref=25 During the past decade, big pharmaceutical companies have been making major efforts to restructure their manufacturing networks. In their haste to shed costs and assets, however, some may be adding risk to their product supply chains. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605694null XML http://www.ptemag.com/pharmtecheurope/Business/The-Pharma-Top-50/ArticleStandard/Article/detail/605705?ref=25 The world's top 50 pharmaceutical companies accounted for prescription drug sales of $558 billion (413 billion euro) in 2008. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605705/Pharma50_flash.jpg XML http://www.ptemag.com/pharmtecheurope/APIs/The-pepper-pot-principle-ensuring-the-most-effecti/ArticleStandard/Article/detail/605704?ref=25 In today's cash-starved economic climate, both large and small pharmaceutical companies are striving to shorten drug development times to enable drugs to be marketed for the maximum amount of time before their patent protection expires. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605704/Robin_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Latest+News/FDA-inspects-Hoviones-API-manufacturing-plant/ArticleStandard/Article/detail/607860?ref=25 Hovione's API plant in Macau (CA, USA), which is responsible for one third of the company's total production, has successfully passed a pre-approval inspection by the FDA. 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607860null HTML http://www.ptemag.com/pharmtecheurope/Editor%27s+comment/We-invite-you-to-Link-in/ArticleStandard/Article/detail/605702?ref=25 You are invited to Link In and Twitter with PTE! 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605702null XML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Creating-certainty-in-an-uncertain-world/ArticleStandard/Article/detail/606011?ref=25 How can companies ensure they create certain outcomes during the economic crisis? 2009-07-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/606011null HTML http://www.ptemag.com/pharmtecheurope/Custom-Manufacturing-Driven-by-Core-Competencies/ArticleStandard/Article/detail/607335?ref=25 Custom Manufacturing Driven by Core Competencies 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607335null PDF http://www.ptemag.com/pharmtecheurope/TLM-Packaging-Machine-for-Wallets-A-beautiful-open/ArticleStandard/Article/detail/607322?ref=25 A wallet is only as attractive as the way it is folded. To achieve high, lasting quality during ongoing production is truly a demanding task for any machine. 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607322null PDF http://www.ptemag.com/pharmtecheurope/Reducing-Risk-with-the-Right-CRO-Partner/ArticleStandard/Article/detail/607330?ref=25 For drug developers, finding the right patients, investigators and outsourcing partners is essential. With shareholders demanding improved efficiencies, the resources, reach and expertise of a contract research organization (CRO) can expedite the research and development process. 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607330null PDF http://www.ptemag.com/pharmtecheurope/Scale-up-of-Crystallisation/ArticleStandard/Article/detail/607331?ref=25 Application of process tomography as a tool for monitoring and scale-up of crystallisation 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607331null PDF http://www.ptemag.com/pharmtecheurope/Ultrasonic-Particle-Engineering-for-the-production/ArticleStandard/Article/detail/607332?ref=25 The control of crystal particle size of active ingredients is necessary when the final product performance is reliant upon having well defined and, ideally, engineered mesoscopic particles, such as in the pharmaceutical and agrochemical industries. 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607332null PDF http://www.ptemag.com/pharmtecheurope/Case+Studies/PTK-Tablet-Presses/ArticleStandard/Article/detail/607323?ref=25 Tablets, PTK Tablet Presses, Surepharm Services 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607323null PDF http://www.ptemag.com/pharmtecheurope/XP500-Optimized-Evolutionary-ODT-Performance/ArticleStandard/Article/detail/607333?ref=25 An orally disintegrating tablet (ODT) is designed to rapidly disintegrate in the oral cavity, providing for the liberation of one or more active pharmaceutical ingredients (API). 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607333null PDF http://www.ptemag.com/pharmtecheurope/Case+Studies/Successful-Cooperation-Yields-Anti-Stick-Rewards/ArticleStandard/Article/detail/607321?ref=25 Successful Cooperation Yields Anti-Stick Rewards 2009-06-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607321null PDF http://www.ptemag.com/pharmtecheurope/Latest+News/Big-Pharma-to-donate-swine-flu-vaccines/ArticleStandard/Article/detail/605714?ref=25 Sanofi-aventis will donate 100 million doses of vaccine against the pandemic H1N1 2009 virus to the World Health Organization (WHO). 2009-06-26T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605714null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/FDA-approves-first-macular-oedema-drug-therapy/ArticleStandard/Article/detail/605708?ref=25 The FDA has approved the first drug therapy for the treatment of macular oedema following branch retinal vein occlusion or central retinal vein occlusion, which is a significant cause of vision loss. 2009-06-26T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605708null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Will-biotech-rule-pharmas-world-in-2014/ArticleStandard/Article/detail/605709?ref=25 According to market analysis firm EvaluatePharma, the top six selling drugs of 2014 are all expected to be biotech products compared with only five in 2008 and one in 2000. 2009-06-26T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605709null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Product-information-management-and-the-pharma-indu/ArticleStandard/Article/detail/606738?ref=25 Good information management is essential to help pharmaceutical companies efficiently translate large amounts of data into drug market applications, achieve fast time to market and reduce costs and in Europe, many companies and regulatory agencies are actively assessing the potential of the EMEA's XML-based Product Information Management initiative. 2009-06-26T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/606738null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Vetter-claims-success-with-new-facility/ArticleStandard/Article/detail/605713?ref=25 Vetter has completed the installation of six automatic packaging lines at its new packaging services facility in Ravensburg (Germany). 2009-06-24T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605713null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EFCG-launches-new-guidelines-compliance-tool/ArticleStandard/Article/detail/605605?ref=25 Following the 2008 launch of the European Fine Chemicals Group (EFCG) Voluntary Guidelines (VGs) to promote supply chain security, the group has now announced the official launch of an assessment template that will allow fine chemicals customers and suppliers to assess and implement this new set of recommendations. 2009-06-23T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605605null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EMEA-launches-public-consultation-on-new-transpare/ArticleStandard/Article/detail/605609?ref=25 The European Medicines Agency (EMEA) is inviting comments on its draft transparency policy. 2009-06-23T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605609null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Budenheim-achieves-GMP-certification/ArticleStandard/Article/detail/605607?ref=25 Budenheim, a producer of pharmaceutical grade Phosphate, is now formally certified according to the ?Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients? (ICH Q7A). 2009-06-23T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605607null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/PEGylated-patent-for-PolyTherics/ArticleStandard/Article/detail/605744?ref=25 PolyTherics's first patent covering the targeted PEGylation of proteins has been allowed in Europe. 2009-06-23T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605744null HTML http://www.ptemag.com/pharmtecheurope/Chemspec-2009-the-numbers/ArticleStandard/Article/detail/605301?ref=25 Chemspec 2009 2009-06-22T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/262009/605301null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Swine-flu-vaccine-manufacture-underway/ArticleStandard/Article/detail/604912?ref=25 Protein Sciences Corp (CT, USA) is the latest company to join the H1N1 influenza vaccine race after initiating manufacture of its vaccine PanBlok, which is made using the company's baculovirus and insect cell manufacturing technology. 2009-06-19T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/604912null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Report-on-follow-on-biologics-sparks-debate/ArticleStandard/Article/detail/604636?ref=25 The Subcommittee on Health of the US House of Representatives Energy and Commerce Committee held hearings last week to discuss the findings of a report by the Federal Trade Commission (FTC) that examined the competitive effects for follow-on-biologics (FOBs). 2009-06-19T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/604636null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Europe-takes-action-on-rare-diseases/ArticleStandard/Article/detail/603814?ref=25 Stakeholders say that Europe and its rare disease patients will benefit from a series of political commitments that Health Ministers from all 27 member states have signed up to by adopting a Council Recommendation on European Action in the Field of Rare Diseases. 2009-06-18T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/603814null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Renvela-approved-for-chronic-kidney-disease/ArticleStandard/Article/detail/603812?ref=25 The European Commission has approved Genzyme Corp's Renvela for patients with chronic kidney disease (CKD). The approval covers both tablet and powder formulations. 2009-06-18T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/603812null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Controversial-EU-cross-border-directive/ArticleStandard/Article/detail/603813?ref=25 Draft legislation that would allow patients to seek treatment in any EU country was attacked at the annual congress of the European Federation of Public Services Union (EPSU), which urged European Union health ministers to redraft the proposal so that its legal basis encompasses public health and not just the internal market. 2009-06-18T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/603813null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Eli-Lilly-faces-lawsuits-for-illegal-marketing/ArticleStandard/Article/detail/603815?ref=25 Eli Lilly urged doctors to prescribe Zyprexa for elderly dementia patients despite having evidence that the medicine was not effective for those patients, says a report by Bloomberg. 2009-06-18T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/603815null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Industry-and-health-agencies-respond-to-influenza-/ArticleStandard/Article/detail/604225?ref=25 Following the World Health Organization?s (WHO) declaration last week of an influenza pandemic, vaccine makers in Europe and China as well as world health agencies are stepping up efforts toward rapid development and approval of an effective vaccine. 2009-06-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/604225null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EMEA-seeks-your-opinion/ArticleStandard/Article/detail/603811?ref=25 Following changes to European legislation, the European Medicines Agency (EMEA) will make public some of the information in EudraCT — a database that contains information on clinical trials in Europe. 2009-06-16T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/252009/603811null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Biologic-manufacturing-facility-to-be-built-in-Ind/ArticleStandard/Article/detail/602774?ref=25 India-based Kemwell plans to build a new biopharmaceutical manufacturing plant in Bangalore (India) in a strategic collaboration with Boehringer Ingelheim (BI, Germany). 2009-06-12T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/602774null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Europe-needs-faster-generic-medicines-uptake/ArticleStandard/Article/detail/602771?ref=25 "EU governments need to ensure fast generic medicines uptake as market access and low market volume in key EU countries is still a real problem and is having a major negative impact on patient access to more affordable treatments." 2009-06-12T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/602771null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EU-wide-recall-of-Raptiva/ArticleStandard/Article/detail/602648?ref=25 The European Medicines Agency (EMEA) has agreed to an EU-wide recall of all the remaining batches of Merck Serono's Raptiva because of the risk of a serious brain infection. Following the recall, the medicine will no longer be available anywhere in the European Union. 2009-06-12T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/602648null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/European-Commission-wont-pursue-directive-for-exci/ArticleStandard/Article/detail/602773?ref=25 The European Commission?s (EC) Directorate-General for Enterprise and Industry (EC–DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients. 2009-06-12T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/602773null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/MHRA-seeks-improved-legislative-framework/ArticleStandard/Article/detail/602772?ref=25 The outcome of a concept paper by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which sought the input of stakeholders on the review and consolidation of the UK medicines legislation, has been published. 2009-06-12T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/602772null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/New-centre-for-research-opens-in-UK/ArticleStandard/Article/detail/602646?ref=25 A new Faculty of Translational Medicine has been established in London (UK) that will increase support for, and enhance collaboration among, researchers as they search for new treatments and diagnostic tests for a range of diseases and conditions. 2009-06-12T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/602646null HTML http://www.ptemag.com/pharmtecheurope/Accelerate-your-therapeutic-protein-development-in/ArticleStandard/Article/detail/602111?ref=25 A 45-minute webinar on assay and system validation hosted by Marian Kelley, contributing author of DeSilva white paper, on behalf of Gyros AB. 2009-06-08T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/242009/602111null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Atherosclerosis-vaccine-receives-EU-funding/ArticleStandard/Article/detail/601191?ref=25 Austria-based AFFiRiS AG is receiving financial support worth several hundred thousand euro for its atherosclerosis vaccine development programme from the European Union's call. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601191null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Genetic-link-to-drug-induced-liver-injury-found/ArticleStandard/Article/detail/601219?ref=25 The International Serious Adverse Event Consortium (SAEC), a nonprofit partnership, has helped the FDA gain significant understanding of the genetic basis for drug-induced liver injury (DILI). 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601219null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Marketing-authorization-withdrawn-for-Biferonex/ArticleStandard/Article/detail/601201?ref=25 BioPartners GmbH (Switzerland) has formally notified the European Medicines Agency (EMEA) of its decision to withdraw the application of a centralized marketing authorization for Biferonex (interferon beta 1a), 6 million-international-unit solution for injection, prefilled syringes for subcutaneous administration. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601201null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/RAPS-enters-Europe/ArticleStandard/Article/detail/601204?ref=25 The Regulatory Affairs Professionals Society (RAPS) — the world's largest international membership organization of regulatory professionals in the medical device, pharmaceutical and biotechnology sectors — has opened a European office in Brussels (Belgium) that will support programmes, events and operations across Europe, as well as serve as the region's headquarters. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601204null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/JampJ-fights-for-Remicade-rights/ArticleStandard/Article/detail/601192?ref=25 Johnson & Johnson is making a break for escape with global sales of the rheumatoid arthritis treatment Remicade, which the company currently shares with Schering-Plough via a distribution agreement. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601192null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/US-issues-new-drug-safety-guidelines/ArticleStandard/Article/detail/601377?ref=25 A discussion draft of the Food Safety Enhancement Act of 2009 has been released, which also contains measures relating to drug safety. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601377null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Brand-makers-abusing-authorized-generics/ArticleStandard/Article/detail/601819?ref=25 The Chief Operating Officer (COO) of one of the world?s largest generics manufacturers has condemned the launch of authorized generics during 180-day exclusivity periods. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601819null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/AstraZeneca-amp-Merck-in-unique-deal/ArticleStandard/Article/detail/601199?ref=25 In a novel collaboration, pharma giants AstraZeneca and Merck will investigate the potential benefits of combining their two early-stage compounds for the treatment of solid cancer tumours. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601199null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EU-DTC-rules-to-change/ArticleStandard/Article/detail/601202?ref=25 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is seeking opinions on a European Commission (EC) proposal that would allow drugmakers to disseminate certain information on prescription medicines directly to European patients. 2009-06-05T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/232009/601202null HTML http://www.ptemag.com/pharmtecheurope/Regulatory/Where-have-we-reached-with-REACH/ArticleStandard/Article/detail/600236?ref=25 The EU has changed history and set the pace for future productrelated legislation with its Registration, Evaluation and Authorization of Chemicals (REACH) Regulation no. 1907/2006, which came into effect in June 2007. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600236null XML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Master-data-management-solutions/ArticleStandard/Article/detail/598921?ref=25 Cognizant talks about the importance of master data management and its newly launched solution. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/212009/598921null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Cobras-oral-vaccination-platform/ArticleStandard/Article/detail/597972?ref=25 Dr Rocky Cranenburgh, Head of Molecular Biology at Cobra Biomanufacturing Plc, talks about the company's unique oral vaccine delivery technology. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/202009/597972null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Identifying-supplier-deficiencies/ArticleStandard/Article/detail/598552?ref=25 When outsourcing, pharmaceutical companies must conduct thorough audits of service providers to ensure they comply with the required quality standard. This audit is usually straightforward, but only if you are fully aware of the written procedure. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/212009/598552null HTML http://www.ptemag.com/pharmtecheurope/Editor%27s+comment/Super-heroes-super-show/ArticleStandard/Article/detail/600229?ref=25 Three-tiered exhibition rooms separated by milelong walkways, the sound of the latest machines showing off the results of their makers' investments, the smell of fresh popcorn, the sight of superheroes and robots, and the constant feeling of aching limbs and sore feet — this pretty much sums up my experience of ACHEMA 2009. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600229null XML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Driving-global-pharmaceutical-security/ArticleStandard/Article/detail/594806?ref=25 The Chief Strategy Officer at SupplyScape offers advice in the battle against counterfeits. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/172009/594806null HTML http://www.ptemag.com/pharmtecheurope/Formulation/Formulation-effects-on-the-thermomechanical-proper/ArticleStandard/Article/detail/599233?ref=25 Understanding a formulation's variable effects on its properties, especially film permeability, is key to designing a robust formulation and reducing variation of a finished product. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/212009/599233/82961765_flash.jpg HTML http://www.ptemag.com/pharmtecheurope/Spotlight/The-RampD-hurdles-for-neglected-diseases/ArticleStandard/Article/detail/600232?ref=25 Modern medicines have dramatically improved the health of millions of people worldwide, but the healthcare situation in industrialized countries is a stark contrast to that in the least developed countries where neglected diseases are still prevalent. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600232null XML http://www.ptemag.com/pharmtecheurope/Outsourcing/Limits-to-CRO-growth/ArticleStandard/Article/detail/600228?ref=25 Is there a point in a CRO's life when contract services begin to look less attractive as a strategic business opportunity? Executives at PPD (NC, USA) seem to think so. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600228null XML http://www.ptemag.com/pharmtecheurope/News/News/ArticleStandard/Article/detail/600233?ref=25 The latest growth forecast for the 2009 pharmaceutical market might have come as a shock to many, but there is still hope for the industry in the form of new product launches and potential blockbusters. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600233null XML http://www.ptemag.com/pharmtecheurope/Biopharmaceuticals/New-expression-systems-create-opportunities-for-in/ArticleStandard/Article/detail/600230?ref=25 There may well be a pending revolution in biopharmaceutical expression systems. Nearly 50% of biomanufacturers today are demanding a whole lot more from their primary expression systems than they have during the past 30 years. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600230null XML http://www.ptemag.com/pharmtecheurope/Filtration/Improving-liposome-integrity-and-easing-bottleneck/ArticleStandard/Article/detail/599016?ref=25 The importance of liposomes as an effective drug delivery system is well accepted in the pharmaceutical industry, but their handling remains a challenge. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/212009/599016/dv844003_flash.jpg HTML http://www.ptemag.com/pharmtecheurope/Validation/Substandard-APIs-we-must-tackle-the-problem-togeth/ArticleStandard/Article/detail/600231?ref=25 In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple — we were there to raise a red flag. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600231/200395152-001_2_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Validation/Why-we-need-mass-serialization-mdash-now/ArticleStandard/Article/detail/600234?ref=25 Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year — in other words, one pack in every 20000 is counterfeit. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600234/200395152-001_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Andrew-MacGarvey-151-Quanticate-the-specialist-bio/ArticleStandard/Article/detail/595119?ref=25 Pharmaceutical Technology Europe interviews Andrew MacGarvey, President at Quanticate (MA, USA), a specialist biometrics company. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/182009/595119null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/The-boom-in-the-Middle-East/ArticleStandard/Article/detail/598916?ref=25 Until recently, the Middle East has accounted for only a fraction of global pharmaceutical sales, but this will soon change as the region's pharmaceutical market is estimated to exceed $18 billion by 2014. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/212009/598916null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/The-UK-bio-industry-on-its-knees/ArticleStandard/Article/detail/595118?ref=25 A survey of UK life sciences companies conducted by the UK's BioIndustry Association (BIA) revealed that many companies are finding it extremely difficult to access financing — partly because the sector is viewed as "too risky" by investors. Pharmaceutical Technology Europe interviews Clive Dix, Chairman of the BIA. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/182009/595118null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/David-Blakey-151-Accelerating-the-development-proc/ArticleStandard/Article/detail/595120?ref=25 David Blakey, Head of Drug Delivery at Cambridge Consultants (UK), talks about the release of the company's Dry Powder Inhaler (DPI) generic specification. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/182009/595120null HTML http://www.ptemag.com/pharmtecheurope/Online+Exclusives/Murray-Aitken-151-forecasted-growth-for-the-2009-g/ArticleStandard/Article/detail/597817?ref=25 Murray Aitken, senior vice president, Healthcare Insight, at IMS Health explains why IMS Health has lowered its predicted growth for the 2009 global pharmaceutical market from a previous forecast in October 2008. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/202009/597817null HTML http://www.ptemag.com/pharmtecheurope/Validation/Taking-the-modular-approach/ArticleStandard/Article/detail/600235?ref=25 Despite the fact that regulatory compliance is fundamental to the pharmaceutical industry, too many manufacturers lose millions of euro in revenue because of poorly or incorrectly validated facilities. With increasingly demanding global regulations and guidance, rising manufacturing costs and dwindling product portfolios, it is vital to achieve efficient and effective compliance of facilities, processes and equipment to retain market competitiveness. 2009-06-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600235/200535486-001_flash.jpg XML http://www.ptemag.com/pharmtecheurope/Latest+News/Whos-the-best-in-global-biotech/ArticleStandard/Article/detail/599862?ref=25 A study has identified the innovative strength of more than 30 countries when it comes to biotechnology. Who came out on top? 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/599862null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EU-amp-US-approval-process-integration-a-necessity/ArticleStandard/Article/detail/599856?ref=25 There is a pressing need to integrate the regulatory environments of the EU and the US, according to new analysis by Frost & Sullivan, which believes the diverse approval processes across different continents are negatively impacting drug launches. 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/599856null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Twice-as-many-therapeutic-peptides-in-the-clinic/ArticleStandard/Article/detail/599867?ref=25 Thanks to advances in synthesis, delivery and formulation, the number of therapeutic peptides entering clinical trials this decade is almost double the rate of the 1990s, and investment in new therapeutic peptide product development is expected to continue at a strong pace for the foreseeable future. 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/599867null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Anti-counterfeiting-pilot-project-launched-in-Swed/ArticleStandard/Article/detail/599858?ref=25 A pilot of the European Federation of Pharmaceutical Industries and Associations (EFPIA) coding and identification solution will be run in Sweden later this year. 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/599858null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/US-orders-H1N1-vaccines-and-vaccine-antigen/ArticleStandard/Article/detail/600031?ref=25 The US Department of Health and Human Services (HHS) this week placed an initial order with Sanofi Pasteur (France) for a vaccine to fight influenza A (H1N1) infection. 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600031null HTML http://www.ptemag.com/pharmtecheurope/APIs/Next-generation-of-API-purification-technologies/ArticleStandard/Article/detail/599864?ref=25 A consortium with a specific focus on removing organic impurities from API production has been selected by the European Commission (EC) to receive funding of approximately 3 million euro. 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/599864null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Novartis-gets-exclusive-option-to-acquire-Elixir-P/ArticleStandard/Article/detail/600034?ref=25 Novartis (Switzerland) has signed an agreement that grants the company an exclusive option to acquire Elixir Pharmaceuticals (MA, USA) upon successful completion of a Phase IIa clinical study of Elixir?s lead oral ghrelin antagonist, which is now the subject of preclinical studies. 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/600034null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/European-initiative-supports-faster-development-of/ArticleStandard/Article/detail/599868?ref=25 Out of 150 applications, 15 research projects aimed at bringing innovative medicines to market faster have been selected to receive 246 million euro from the European Commission (EC) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/599868null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Xention-strengthens-team/ArticleStandard/Article/detail/599869?ref=25 UK-based biopharmaceutical firm Xention has strengthened its team with the appointment of Dr Calum Graham as Director of Business Development. 2009-05-29T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/222009/599869null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/ProCepT-performs-at-ACHEMA/ArticleStandard/Article/detail/599394?ref=25 At the recent ACHEMA 2009 exhibition held in Germany, ProCepT (Belgium) and its subsidiary launched two new products. 2009-05-23T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/212009/599394null HTML