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. 2010-07-30T06:35:02Z http://www.ptemag.com/pharmtecheurope/Editor%27s+Corner/Overtons-rule-is-over/ArticleStandard/Article/detail/546956?ref=25 It is the 1980s. Ernst Overton at the University of Zurich (Switzerland) declares that those substances that dissolve in lipids pass more easily into a cell than those that dissolve in water. 2009-09-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/362008/546956null HTML http://www.ptemag.com/pharmtecheurope/On-top-of-the-game/ArticleStandard/Article/detail/546957?ref=25 It's hard being on top of the game. The big players in the pharmaceutical industry are constantly immersed in a relentless fight to become number one and it's not pretty up there. 2009-09-01T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/362008/546957null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Step-carefully-into-foreign-affairs/ArticleStandard/Article/detail/617977?ref=25 As the pharmaceutical industry looks to emerging markets, corruption becomes an important issue. 2009-08-14T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/332009/617977null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/GSK-buys-rights-to-staph-infection-vaccine/ArticleStandard/Article/detail/617978?ref=25 GlaxoSmithKline (GSK) has signed an agreement to acquire US-based Nabi Biopharmaceuticals' PentaStaph programme, which will provide the company with a five component vaccine candidate for Pentavalent S. aureus. 2009-08-14T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/332009/617978null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Six-step-plan-for-improved-FDA-enforcement/ArticleStandard/Article/detail/618345?ref=25 FDA Commissioner Margaret Hamburg has outlined six initial steps designed to improve the effectiveness and timeliness of FDA?s regulatory and enforcement system. 2009-08-14T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/332009/618345null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/FDA-guidance-on-monitoring-at-risk-melamine-contam/ArticleStandard/Article/detail/618346?ref=25 The FDA has released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination. 2009-08-14T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/332009/618346null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Green-manufacturing-with-marine-microbes/ArticleStandard/Article/detail/617979?ref=25 Manufacturing methods for new drugs could be made greener and more efficient with the help of marine microbes. 2009-08-14T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/332009/617979null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Antipsychotic-drugs-dominate/ArticleStandard/Article/detail/617975?ref=25 There is a considerable commercial opportunity for developers of antipsychotic drugs, according to market analysts Datamonitor, which claims that this class of drugs dominates the US market and boasted a global value of approximately $22 billion in 2008. 2009-08-14T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/332009/617975null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/BIO-asks-Supreme-Court-to-overturn-iBilskii/ArticleStandard/Article/detail/618347?ref=25 The Biotechnology Industry Organization (BIO) has filed an amicus brief asking the US Supreme Court to overturn Bilski versus Doll, a decision of the US Court of Appeals for the Federal Circuit. 2009-08-13T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/332009/618347null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Freeze-drying-centre-of-excellence-unveiled/ArticleStandard/Article/detail/616344?ref=25 Reig Jofre has revealed further details about its Barcelona (Spain) based Centre of Excellence in the Freeze Drying Process — a project that represents an investment of approximately 12 million euro. 2009-08-07T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/322009/616344null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Pfizer-Vs-Nigerias-Kano-State-case-comes-to-a-clos/ArticleStandard/Article/detail/616358?ref=25 An agreement has been reached between Pfizer and Nigeria's Kano State government following the long-running Trovan trial, which stems from the accusation that Pfizer illegally tested the antibiotic Trovan (trovafloxacin) on children in 1996 during a meningitis outbreak. 2009-08-07T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/322009/616358null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/String-of-attacks-aimed-at-Novartis-CEO/ArticleStandard/Article/detail/616573?ref=25 Novartis has confirmed that the ashes of CEO Daniel Vasella?s mother have been stolen and his holiday home set fire to. 2009-08-06T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/322009/616573null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EMEA-and-FDA-collaborate-on-good-clinical-practice/ArticleStandard/Article/detail/616339?ref=25 A joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities has been launched by the EMEA and the FDA. 2009-08-06T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/322009/616339null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Cash-boost-for-projects-to-replace-reduce-and-refi/ArticleStandard/Article/detail/616343?ref=25 Thirteen novel projects that aim to replace, reduce or refine animal testing have received funding totaling £4.5 million (approximately 5.3 million euro) from the UK's National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). 2009-08-06T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/322009/616343null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EU-issues-study-on-REACH-implementation/ArticleStandard/Article/detail/616571?ref=25 The Society of Chemical Manufacturers and Affiliates (SOCMA) has reported that Eurostat, the Statistical Office of the European Communities, has published a baseline study or the first snapshot of REACH policy in the preregistration phase. 2009-08-06T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/322009/616571null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Personalized-medicine-drives-MampAs/ArticleStandard/Article/detail/614716?ref=25 The number of alliances between diagnostics and pharmaceutical companies is set to rise because of the growth of personalized medicine, according to a report from PricewaterhouseCoopers. 2009-07-31T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614716null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/New-life-pumped-into-UK-pharma/ArticleStandard/Article/detail/614717?ref=25 The UK's pharma sector will soon receive its own body to help employers drive the key skills agenda of the industry. 2009-07-31T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614717null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/BMS-To-Acquire-Medarex/ArticleStandard/Article/detail/614724?ref=25 In a move to strengthen development of its biologics portfolio, Bristol-Myers Squibb (BMS) has agreed to acquire the biopharmaceutical company Medarex (NJ, USA) for approximately $2.4 billion. 2009-07-31T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614724null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/APIs-delivered-by-sticky-webs/ArticleStandard/Article/detail/614718?ref=25 GlaxoSmithKline (GSK) has granted 42 Technology worldwide pharmaceutical rights to a new precision powder dispensing technology that can quickly print powdered APIs onto edible or inert webs coated with adhesive to create a novel dose form. 2009-07-31T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614718null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Extending-antibody-shelf-life/ArticleStandard/Article/detail/614723?ref=25 Researchers working on extending the shelf life of antibody drugs may find help in a computer model developed by a research team at MIT (MA, USA). 2009-07-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614723null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Sanofi-Pasteur-boosts-vaccine-portfolio/ArticleStandard/Article/detail/614722?ref=25 Sanofi aventis's vaccines division, Sanofi Pasteur (France), has acquired the ShanH subsidiary of Mërieux Alliance, which will give Sanofi Pasteur a majority stake in the Indian based vaccine producer Shantha Biotechnics. 2009-07-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614722null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Flu-vaccines-fast-tracked-in-the-EU/ArticleStandard/Article/detail/614715?ref=25 The EMEA is racing to fast track the review of data on H1N1 pandemic vaccines before the start of the Northern hemisphere flu season, which is expected to begin in September. 2009-07-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614715null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Transgenic-rats-provide-new-models-of-human-diseas/ArticleStandard/Article/detail/614719?ref=25 Transgenic rats, created using a novel application of zinc finger nuclease (ZFN) technology, could aid the development of animal models of human diseases. 2009-07-30T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/312009/614719null HTML http://www.ptemag.com/pharmtecheurope/Watson-Marlow-151-peristaltic-pump-technolog/ArticleStandard/Article/detail/613583?ref=25 Peristaltic pumps are at the centre of many single-use biopharmaceutical processes and medical/surgical instruments. Their non-contacting design makes them uniquely suited to these applications, providing lower contamination risks and reduced validation requirements. 2009-07-24T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/613583null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Collaboration-to-tackle-asthma/ArticleStandard/Article/detail/612575?ref=25 A new collaboration in the UK has been established to identify treatments that will stop asthma from worsening rather than simply alleviating the symptoms. 2009-07-24T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/612575null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/118-rise-in-medicines-detained-by-EU-customs/ArticleStandard/Article/detail/612576?ref=25 Statistics published by the European Commission show a 118% increase in the number of medicines detained by EU customs in 2008 compared with 2007. 2009-07-24T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/612576null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/US-API-manufacturing-facility-to-be-dedicated/ArticleStandard/Article/detail/612579?ref=25 A new, large-scale manufacturing facility offering western-based API supply will be dedicated on 30 July 2009 in Germantown (WI, USA) by Cambridge Major Laboratories. 2009-07-24T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/612579null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Final-guidance-given-on-listing-drug-substance-imp/ArticleStandard/Article/detail/612911?ref=25 The FDA has posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances. 2009-07-24T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/612911null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Microneedles-moving-into-the-market/ArticleStandard/Article/detail/612574?ref=25 Microneedle technology is moving closer to commercialization, according to research by Greystone Associates, as devices are being investigated by several companies lured by the potential advantages of extending the reach of transdermal drug delivery and the ability to meet the trend towards self administration. 2009-07-22T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/612574null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EC-approves-Pfizers-Wyeth-take-over/ArticleStandard/Article/detail/612471?ref=25 Pfizer's proposed acquisition of Wyeth appears to be on track after the European Commission (EC) issued its thumbs up under the EU's Merger Regulation; however, the approval came with a price as Pfizer has been told to divest several types of animal operations in the European Economic Area. 2009-07-21T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/612471null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/FDAs-Dr-Srinivasan-discusses-question-based-review/ArticleStandard/Article/detail/612910?ref=25 Dr Aloka Srinivasan of the FDA's Office of Generic Drugs speaks about question-based reviews for generic drugs. 2009-07-20T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/302009/612910null HTML http://www.ptemag.com/pharmtecheurope/Industry+Leaders/Domainex-151-Helping-to-improve-asthma-treatments/ArticleStandard/Article/detail/610210?ref=25 An interview with Trevor Perrior, Research Director at Domainex. Domainex is currently collaborating with St George's University of London and the University of Manchester in the hope of developing a better treatment for asthma. 2009-07-20T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/610210null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Final-counterfeit-gang-member-sentenced/ArticleStandard/Article/detail/610979?ref=25 The UK's largest counterfeit drug operation has ended in the sentencing of its seventh and final member. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/292009/610979null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/SOCMA-supports-extension-of-CFATS/ArticleStandard/Article/detail/611227?ref=25 The Society of Chemical Manufacturers and Affiliates (SOCMA) this week stated its support to the US Senate for approving legislation that would extend existing chemical security standards for one more year. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/292009/611227null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/New-FDA-anticounterfeiting-draft-guidance/ArticleStandard/Article/detail/611223?ref=25 The FDA issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/292009/611223null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/US-Committee-votes-on-generic-competition/ArticleStandard/Article/detail/611225?ref=25 This week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) issued their opposing statements in reaction to the July 13 passage of an amendment from the US Senate Committee on Health, Education, Labor, and Pensions (HELP) regarding the creation of a pathway for the approval of new competitors of biologic drugs. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/292009/611225null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Pharma-tackles-tropical-diseases/ArticleStandard/Article/detail/610155?ref=25 Less well-known tropical diseases are receiving growing attention and research efforts from the pharmaceutical industry, according to a report from the Federation of Pharmaceutical Manufacturers & Associations (IFPMA). 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/610155null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/European-Pharmacopoeia-Commission-announces-new-st/ArticleStandard/Article/detail/610154?ref=25 The European Pharmacopoeia Commission, which will celebrate its 60th anniversary this year, has announced progress towards international harmonization, as well as other ongoing activities, at the 134th session of the European Pharmacopoeia in France. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/610154null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/All-aboard-the-Twitter-bandwagon/ArticleStandard/Article/detail/610859?ref=25 Resistance to the social networking revolution has been particularly high amongst pharmaceutical industry professionals, though now it seems that more and more are coming round to the idea. Interestingly, it?s not only the pharma elite that are jumping on the bandwagon; so too are government agencies and, most notably, the FDA. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/292009/610859null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/UK-chemical-industry-under-threat/ArticleStandard/Article/detail/610858?ref=25 In the wake of Dow Chemical's announcement that it is to close facilities in the UK, the country's biggest union, Unite, has called for urgent intervention from the Government to avert, what it believes, could be a crisis in the UK chemical sector. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/292009/610858null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/MHRA-offers-online-reporting-for-antiviral-meds/ArticleStandard/Article/detail/610156?ref=25 The UK's Medicines and Healthcare Regulatory Agency (MHRA) intends to keep a close eye on the safety of the swine flu antiviral medicines Tamiflu and Relenza as their use increases, by using an online reporting system. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/610156null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Approximately-3-billion-boost-for-FDA/ArticleStandard/Article/detail/611221?ref=25 Last week, the US House of Representatives passed H.R. 2997, the Fiscal Year 2010 Agriculture-FDA Appropriations bill, which sets aside $2.995 billion for the US Food and Drug Administration. 2009-07-17T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/292009/611221null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/IMA-Group-acquires-PharmaSiena/ArticleStandard/Article/detail/608795?ref=25 Through its subsidiary IMA Life Srl, IMA SpA has acquired 51% of PharmaSiena Srl, which designs and produces filling machines for ampoules and syringes in aseptic environments. 2009-07-16T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/608795null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Spain-constructs-first-vaccine-plant/ArticleStandard/Article/detail/608793?ref=25 Spain's first in-border facility to develop pandemic and seasonal influenza vaccines will be built under a 60 million euro programme sponsored and led by the Spanish Ministry of Health. 2009-07-10T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/608793null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Roche-waves-goodbye-to-pharma/ArticleStandard/Article/detail/608792?ref=25 Roche appears to want out of the Big Pharma crowd. A report from the UK's Financial Times claims that Roche will not renew its membership of the Association of the British Pharmaceutical Industry (ABPI), while the company has also confirmed that it has officially withdrawn from the US's Pharmaceutical Research and Manufacturers Association (PhRMA). 2009-07-10T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/608792null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Once-daily-diabetes-treatment-gets-EU-OK/ArticleStandard/Article/detail/608790?ref=25 The European Commission has granted marketing authorization for Novo Nordisk's Victoza (liraglutide). 2009-07-10T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/608790null HTML http://www.ptemag.com/pharmtecheurope/Youre-European-right-Youve-heard-of-Twitter/ArticleStandard/Article/detail/610202?ref=25 American business Bible Forbes doesn't think you have, at least not if you're a European CEO. Then again, the Forbes' article that says European CEOs don't Tweet was written six weeks ago, and a lot can change in six weeks Twitter time. 2009-07-10T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/610202null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Pharmerging-markets-and-the-new-world-order/ArticleStandard/Article/detail/607499?ref=25 An IMS press briefing earlier this month dramatically predicted a new world ranking of global pharma markets by 2013. But there's more to just knowing where these markets are in order to succeed in the 'new world order.' 2009-07-10T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/272009/607499null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Fake-Tamiflu-warning/ArticleStandard/Article/detail/608791?ref=25 With the World Health Organization (WHO) having declared the spread of swine flu "unstoppable" at a recent meeting in Mexico, there is increasing concern about counterfeits of Roche's anti-viral medicine Tamiflu, which are being purchased over the internet by panicking consumers. 2009-07-10T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/608791null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/EC-final-report-condemns-industry-malpractice/ArticleStandard/Article/detail/609486?ref=25 The European Commission has confirmed that the market entry of generic drugs is delayed and that company practices are among the causes in its final report on the competition inquiry into the pharmaceutical sector. 2009-07-10T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/609486null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/JampJ-invests-15-billion-in-deal-with-Elan/ArticleStandard/Article/detail/609396?ref=25 ohnson & Johnson (J&J, NJ, USA) has agreed to pay $1 billion (719 million euro) to acquire the assets and rights of the Alzheimer’s immunotherapy programme (AIP) of the biopharmaceutical company Elan (Ireland), to form a new company with Elan based on the AIP programme, and gain an 18.4% stake in Elan. 2009-07-09T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/609396null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/USP-seeks-comments-on-four-excipient-monographs/ArticleStandard/Article/detail/609395?ref=25 The US Pharmacopeia is revising its monographs for four pharmaceutical excipients: propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystalllizing sorbitol solution. 2009-07-09T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/609395null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Final-stem-cell-research-rules-issued/ArticleStandard/Article/detail/609397?ref=25 The US National Institutes of Health (NIH) have issued on 7 July final guidelines for human stem-cell research that widen the door to the cell lines that can be used if they meet certain ethical requirements. 2009-07-09T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/609397null HTML http://www.ptemag.com/pharmtecheurope/Latest+News/Two-patents-for-PolyTherics-in-record-time/ArticleStandard/Article/detail/609394?ref=25 Only two weeks after being granted a European patent covering the targeted PEGylation of proteins, PolyTherics has been granted a patent for the same technology — TheraPEG — in the US. 2009-07-08T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/609394null HTML http://www.ptemag.com/pharmtecheurope/TLM-Packaging-Machine-for-Wallets-A-beautiful-open/ArticleStandard/Article/detail/608775?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. 2009-07-06T04:00:00Z http://www.ptemag.com/pharmtecheurope/data/articlestandard/pharmtecheurope/282009/608775null PDF 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/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/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/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/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/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/Online+Only/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/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/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/Online+Only/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/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/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/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/Peer-Reviewed+Research/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/IT/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/Manufacturing/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/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/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/Online+Only/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/Manufacturing/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/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/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/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/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/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/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/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/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/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/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/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/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/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/IT/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/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/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/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/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/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/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