Pharmaceutical Technology - Outsourcing http://pharmtech.findpharma.com/pharmtech/Outsourcing/Article/list/40940 Contract manufacturing organizations (CMOs) and contract research organizations (CROs). Global sourcing of pharma ingredients and services. Trends and challenges for the biopharmaceutical and pharmaceutical industries. 2009-11-21T19:46:09Z Week of Nov. 16, 2009: GSK and Nabi Form Nicotine Vaccine Agreement; Eli Lilly Research Exec to Retire; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Nov-16-2009-GSK-and-Nabi-Form-Nicotine-Vac/ArticleStandard/Article/detail/642581?contextCategoryId=40940&ref=25 Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more... 2009-11-19T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472009/642581null HTML Week of Nov. 9, 2009: Merck and Schering-Plough Begin Combined Operations; UCB Appoints VP; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Week-of-Nov-9-2009-Merck-and-Schering-Plough-Begin/ArticleStandard/Article/detail/640959?contextCategoryId=40940&ref=25 Company and People Notes: 3M forms agreement with VaxInnate; TRIN Pharma appoints CEO; More... 2009-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/640959null HTML Week of Nov. 2, 2009: Eli Lilly Opens Biotech Center; Johnson & Johnson Announces Restructuring; PPD Acquires Chinese CRO; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Nov-2-2009-Eli-Lilly-Opens-Biotech-Center-/ArticleStandard/Article/detail/639212?contextCategoryId=40940&ref=25 Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639212null HTML Lonza Restructures, Plans Cost Reductions http://pharmtech.findpharma.com/pharmtech/Ingredients/Lonza-Restructures-Plans-Cost-Reductions/ArticleStandard/Article/detail/639210?contextCategoryId=40940&ref=25 Lonza (Basel, Switzerland), the large contract manufacturer of small-molecule and biologic-based active pharmaceutical ingredients (APIs), announced last week a series of cost-cutting measures for the next 12 to 18 months. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639210null HTML DIY Healthcare Reform http://pharmtech.findpharma.com/pharmtech/IT/DIY-Healthcare-Reform/ArticleStandard/Article/detail/639194?contextCategoryId=40940&ref=25 While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639194null XML Sharing Supply-Chain Security http://pharmtech.findpharma.com/pharmtech/Ingredients/Sharing-Supply-Chain-Security/ArticleStandard/Article/detail/639209?contextCategoryId=40940&ref=25 A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209/pt1109_coverstory_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209null XML Report from: the Philippines http://pharmtech.findpharma.com/pharmtech/Article/Report-from-the-Philippines/ArticleStandard/Article/detail/639208?contextCategoryId=40940&ref=25 New pricing controls and healthcare reforms may be pushing the pharmaceutical market out of this southeast Asian country. This article contains bonus online-exclusive material. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639208/pt-1109-Philippines-p18_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639208/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639208null XML Facing Reality http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Facing-Reality/ArticleStandard/Article/detail/639202?contextCategoryId=40940&ref=25 Contract organizations waiting for the pipeline to come roaring back are kidding themselves. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639202null XML Stay Afloat with Lessons Learned http://pharmtech.findpharma.com/pharmtech/IT/Stay-Afloat-with-Lessons-Learned/ArticleStandard/Article/detail/639195?contextCategoryId=40940&ref=25 FDA's Edwin Rivera-Martinez on dodging supply-chain challenges. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639195null XML Reality not insanity http://pharmtech.findpharma.com/pharmtech/Outsourcing/Reality-not-insanity/ArticleStandard/Article/detail/637636?contextCategoryId=40940&ref=25 Apopular definition of insanity is repeating the same task over and over again while expecting a different result. It would appear, therefore, that many people in the contract services industry think the major global bio/pharma companies are insane. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637636null XML House Committee Passes IST Requirements in Chemical Facility Security Bill http://pharmtech.findpharma.com/pharmtech/Ingredients/House-Committee-Passes-IST-Requirements-in-Chemica/ArticleStandard/Article/detail/637178?contextCategoryId=40940&ref=25 The House Energy and Commerce Committee approved H.R. 2868, the "Chemical Facility Anti-Terrorism Act of 2009," a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards (CFATS) program. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637178null HTML Week of Oct. 26, 2009: OXiGENE to Acquire VaxGen; Warner Chilcott Appoints Global R&D President; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-26-2009-OXiGENE-to-Acquire-VaxGen-Warn/ArticleStandard/Article/detail/637174?contextCategoryId=40940&ref=25 Also, Astellas and Medivation sign development pact; WuXi PharmaTech appoints VP of business development, more... 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637174null HTML Uniting all CROs http://pharmtech.findpharma.com/pharmtech/News/Uniting-all-CROs/ArticleStandard/Article/detail/635281?contextCategoryId=40940&ref=25 US-based CRO, Health Decisions, hopes to raise the efficacy standards for complex studies and help companies get products to market faster by establishing an international network of CROs. 2009-10-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635281null HTML Week of Oct. 19, 2009: Lonza Drops Bid for Patheon; Peregrine Appoints Head of Regulatory Affairs; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-19-2009-Lonza-Drops-Bid-for-Patheon-Pe/ArticleStandard/Article/detail/635533?contextCategoryId=40940&ref=25 Company and People Notes: SurModics forms agreement with Roche and Genentech; Hospira names Daphne Jones senior VP and chief information officer; more... 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635533null HTML Week of Oct. 12, 2009: GSK and Prosensa Form Pact; Cardiokine Appoints CEO; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-12-2009-GSK-and-Prosensa-Form-Pact-Car/ArticleStandard/Article/detail/633981?contextCategoryId=40940&ref=25 Company and People Notes: Bayer Schering Pharma forms collaboration with Compugen; Takeda San Francisco appoints VP of process science; more... 2009-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422009/633981null HTML Expansion Plan http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Expansion-Plan/ArticleStandard/Article/detail/631824?contextCategoryId=40940&ref=25 Contract-service providers are expanding their offerings in this slow-growth environment. 2009-10-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631824null XML Week of Oct. 5, 2009: Merck and CSL Sign Flu Vaccine Pact; Cardinal Health Names VP; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-5-2009-Merck-and-CSL-Sign-Flu-Vaccine-/ArticleStandard/Article/detail/632124?contextCategoryId=40940&ref=25 Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more... 2009-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632124null HTML Risk Evaluation and Mitigation Strategies (REMS) Under FDAAA http://pharmtech.findpharma.com/pharmtech/Whitepapers/Risk-Evaluation-and-Mitigation-Strategies-REMS-Und/ArticleStandard/Article/detail/614075?contextCategoryId=40940&ref=25 On March 25, 2008, new legislation designated as the Food and Drug Administration Amendments Act of 2007 (FDAAA; "the Act") took effect, which directed FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety. In September 2009, FDA announced a draft guidance to assist sponsors in the preparation of a REMS. The guidance provides links to a number of resources available at FDA to aid in REMS preparation. 2009-10-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614075null REMOTE Pediatric Exclusivity and Drug Development Requirements in the Overall Pediatric Population http://pharmtech.findpharma.com/pharmtech/Manufacturing/Pediatric-Exclusivity-and-Drug-Development-Require/ArticleStandard/Article/detail/631379?contextCategoryId=40940&ref=25 Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only a small fraction of the drugs marketed and used as therapies in the United States have been studied in pediatric patients 0–16 years of age. Recent data demonstrates that only about 25% of approved drugs marketed in the United States have adequate pediatric data to support approval of product labeling by FDA for dosing, safety, or efficacy in children. This lack of appropriate pediatric testing and labeling increases the chances of incorrect dosing, thereby exposing pediatric patients to either an increased risk of adverse reactions or less than optimal therapeutic benefits. 2009-10-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631379null REMOTE The Regulatory Paradox of Laboratory Developed Tests http://pharmtech.findpharma.com/pharmtech/Manufacturing/The-Regulatory-Paradox-of-Laboratory-Developed-Tes/ArticleStandard/Article/detail/631381?contextCategoryId=40940&ref=25 The development of increasingly more complex and sophisticated in vitro diagnostic (IVD) devices by clinical laboratories has precipitated FDA concern regarding a lack of product controls. These tests are often produced using available marketed kits, may include components purchased from a commercial supplier, and are offered for use as a diagnostic service. FDA contends that test ingredients or components used in the production of LDTs are essentially unregulated, therefore, of unpredictable quality. The regulatory boundary between FDA-regulated medical devices LDTs exempt from FDA jurisdiction remains somewhat blurred; however, the looming finalization of the CPG and IDVMIA guidance documents stand to better clarify this borderline. 2009-10-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631381null REMOTE Multinational Firms Stake Claims http://pharmtech.findpharma.com/pharmtech/Article/Multinational-Firms-Stake-Claims/ArticleStandard/Article/detail/632994?contextCategoryId=40940&ref=25 This article is part of a Special Report on the Emerging Markets of The East, October 2009 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632994/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632994null XML PhRMA's Stake in Reform http://pharmtech.findpharma.com/pharmtech/IT/PhRMAs-Stake-in-Reform/ArticleStandard/Article/detail/631752?contextCategoryId=40940&ref=25 The nation's healtcare system needs an overhaul, but it has to be done right. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631752null XML Report From: India http://pharmtech.findpharma.com/pharmtech/Article/Report-From-India/ArticleStandard/Article/detail/631715?contextCategoryId=40940&ref=25 Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631715/INDIA_OCT_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631715null XML Pharma Capsules http://pharmtech.findpharma.com/pharmtech/Article/Pharma-Capsules/ArticleStandard/Article/detail/631712?contextCategoryId=40940&ref=25 Brief pharmaceutical news items for October 2009. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631712null XML Sizing Up the CDMO Market http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Sizing-Up-the-CDMO-Market/ArticleStandard/Article/detail/631751?contextCategoryId=40940&ref=25 A new analysis highlights growth drivers and challenges for clinical supply-chain services. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631751null XML CROs and CMOs Go Further East http://pharmtech.findpharma.com/pharmtech/Article/CROs-and-CMOs-Go-Further-East/ArticleStandard/Article/detail/632989?contextCategoryId=40940&ref=25 Contract research organizations such as Covance are heading further east through Europe. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632989/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632989null XML Standard-Setting Bodies Engage Russia http://pharmtech.findpharma.com/pharmtech/Article/Standard-Setting-Bodies-Engage-Russia/ArticleStandard/Article/detail/632991?contextCategoryId=40940&ref=25 As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632991/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632991null XML The Emerging Markets of the East http://pharmtech.findpharma.com/pharmtech/Article/The-Emerging-Markets-of-the-East/ArticleStandard/Article/detail/631710?contextCategoryId=40940&ref=25 The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631710/russia_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631710null XML Technical Note: The Case for Supplier Qualification http://pharmtech.findpharma.com/pharmtech/Article/Technical-Note-The-Case-for-Supplier-Qualification/ArticleStandard/Article/detail/631711?contextCategoryId=40940&ref=25 This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631711null XML Looking Ahead: The Pharmaceutical-Science Industry http://pharmtech.findpharma.com/pharmtech/IT/Looking-Ahead-The-Pharmaceutical-Science-Industry/ArticleStandard/Article/detail/631750?contextCategoryId=40940&ref=25 AAPS President offers hope and solutions for the industry's challenging future. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631750null XML How to manage the threat of the global supply chain and save money http://pharmtech.findpharma.com/pharmtech/Outsourcing/How-to-manage-the-threat-of-the-global-supply-chai/ArticleStandard/Article/detail/626887?contextCategoryId=40940&ref=25 Julian Mosquera, Director of LCP Consulting, advises how pharma companies can make their supply chains leaner. 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382009/626887/thumbnail_thumbnail.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382009/626887null HTML Is all sunny in Spanish pharma? http://pharmtech.findpharma.com/pharmtech/Outsourcing/Is-all-sunny-in-Spanish-pharma/ArticleStandard/Article/detail/629828?contextCategoryId=40940&ref=25 Despite the economic downturn, Spain's pharmaceutical industry continues to grow — particularly when it comes to biotechnology. 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/629828/Sutton_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/629828null XML Week of Sept. 28, 2009: J&J and Crucell Enter Collaboration; Pfizer Elects Two Directors; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-28-2009-JampJ-and-Crucell-Enter-Colla/ArticleStandard/Article/detail/630279?contextCategoryId=40940&ref=25 Company and People Notes: Boehringer Ingelheim will acquire Wyeth's animal health business; Amsterdam Molecular Therapeutics appoints CEO; more... 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/630279null HTML Week of Sept. 21, 2009: AstraZeneca and Nektar Sign License Agreement; Eli Lilly Names President of Lilly USA, More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-21-2009-AstraZeneca-and-Nektar-Sign-L/ArticleStandard/Article/detail/628576?contextCategoryId=40940&ref=25 Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more... 2009-09-24T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392009/628576null HTML TECHNICAL TRANSFER DOCUMENTATION IS KEY FOR SUCCESS http://pharmtech.findpharma.com/pharmtech/Outsourcing/TECHNICAL-TRANSFER-DOCUMENTATION-IS-KEY-FOR-SUCCES/ArticleStandard/Article/detail/628069?contextCategoryId=40940&ref=25 Clearly defined objectives and project requirements between the pharmaceutical company and their contract packager need to be spelled out ? in writing ? in a Technical Transfer Document prior to any pharma packaging project. A published report documenting details for the customer and the packager is a critical component for success. 2009-09-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392009/628069null REMOTE Week of Sept. 14, 2009: Evotec and Biogen Idec Form Pact; Marijn Dekkers Leaves Thermo Fisher Scientific for Bayer; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-14-2009-Evotec-and-Biogen-Idec-Form-P/ArticleStandard/Article/detail/626906?contextCategoryId=40940&ref=25 Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more... 2009-09-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382009/626906null HTML The Advantages of Small-Format Equipment: A Q&A with Scott C. Garverick http://pharmtech.findpharma.com/pharmtech/Manufacturing/The-Advantages-of-Small-Format-Equipment-A-QampA-w/ArticleStandard/Article/detail/625918?contextCategoryId=40940&ref=25 Small-format packaging equipment can provide benefits to the pharmaceutical industry such as quick changeover and low tooling costs. The machines also can shorten the time it takes to bring a product to the market. 2009-09-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/625918null HTML Week of Sept. 7, 2009: Facet Rejects Biogen Idec's Proposal; Roche Announces Management Changes; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-7-2009-Facet-Rejects-Biogen-Idecs-Pro/ArticleStandard/Article/detail/624922?contextCategoryId=40940&ref=25 Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more... 2009-09-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624922null HTML USP to Develop Standards with Mexican Commission http://pharmtech.findpharma.com/pharmtech/Ingredients/USP-to-Develop-Standards-with-Mexican-Commission/ArticleStandard/Article/detail/623593?contextCategoryId=40940&ref=25 The US Pharmacopeial Convention (USP) and the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) signed a memorandum of understanding (MOU) last week. 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623593null HTML Week of Aug. 31, 2009: Roche Purchases Lonza Facility; SCOLR Pharma Names CEO; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Week-of-Aug-31-2009-Roche-Purchases-Lonza-Facility/ArticleStandard/Article/detail/623587?contextCategoryId=40940&ref=25 Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more... 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623587null HTML Quality by Enforcement http://pharmtech.findpharma.com/pharmtech/IT/Quality-by-Enforcement/ArticleStandard/Article/detail/624202?contextCategoryId=40940&ref=25 After years of promomting QbD concepts, FDA's ready to take action on nonconformers. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624202null XML A Brave New Path for Pharma http://pharmtech.findpharma.com/pharmtech/Article/A-Brave-New-Path-for-Pharma/ArticleStandard/Article/detail/624200?contextCategoryId=40940&ref=25 Personalized medicine and integrated healthcare delivery require new business and pricing models. This article contains bonus online-exclusive material. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624200/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624200null XML Pharma Capsules http://pharmtech.findpharma.com/pharmtech/Ingredients/Pharma-Capsules/ArticleStandard/Article/detail/625569?contextCategoryId=40940&ref=25 Brief pharmaceutical news items for September 2009. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/625569null XML Inside IPEC–Americas: Evaluating Excipient Stability http://pharmtech.findpharma.com/pharmtech/Ingredients/Inside-IPECndashAmericas-Evaluating-Excipient-Stab/ArticleStandard/Article/detail/624205?contextCategoryId=40940&ref=25 IPEC's new stability testing guide takes into account the full supply chain's storage conditions. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624205null XML Tracking CMO Activity http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Tracking-CMO-Activity/ArticleStandard/Article/detail/624204?contextCategoryId=40940&ref=25 Select contract manufacturing organizations roll out expansions for production of active pharmaceutical ingredients and intermediates. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624204null XML Expansion Plan http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Expansion-Plan/ArticleStandard/Article/detail/624203?contextCategoryId=40940&ref=25 Contract-service providers are expanding their offerings in this slow-growth environment. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624203null XML The Go/No-Go Mindset http://pharmtech.findpharma.com/pharmtech/IT/The-GoNo-Go-Mindset/ArticleStandard/Article/detail/624651?contextCategoryId=40940&ref=25 As new process validation guidelines emerge, industry needs to reinvent how it releases product. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624651null XML The Executive Guide to Contracts & Chargebacks Management http://pharmtech.findpharma.com/pharmtech/Whitepapers/The-Executive-Guide-to-Contracts-amp-Chargebacks-M/ArticleStandard/Article/detail/622962?contextCategoryId=40940&ref=25 When it comes to Contracts and Chargebacks - the stakes are high - as credits for chargebacks can often exceed millions of dollars each month. If you find yourself faced with addressing changing regulatory requirements, managing hundreds of contracts, and validating and processing chargeback submissions, we encourage you to learn more in this white paper. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/622962null REMOTE What to consider when expanding businesses into North America http://pharmtech.findpharma.com/pharmtech/Outsourcing/What-to-consider-when-expanding-businesses-into-No/ArticleStandard/Article/detail/621307?contextCategoryId=40940&ref=25 Increase your chances of success in the biggest market in the world. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621307/Cairns_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621307null XML Belgium: Will its enviable geographic position continue to ensure success in pharma? http://pharmtech.findpharma.com/pharmtech/Outsourcing/Belgium-Will-its-enviable-geographic-position-cont/ArticleStandard/Article/detail/621299?contextCategoryId=40940&ref=25 Belgium is one of the largest centres for pharmaceutical distribution and has the second highest number of pharma exports per capita worldwide. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621299/belgium_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621299null XML Applying Biocatalysis: A Technical Forum http://pharmtech.findpharma.com/pharmtech/Ingredients/Applying-Biocatalysis-A-Technical-Forum/ArticleStandard/Article/detail/623098?contextCategoryId=40940&ref=25 Scientists from DSM and Kaneka discuss various techniques in this roundtable moderated by Patricia Van Arnum. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623098null XML Market Outlook for Biosimilars http://pharmtech.findpharma.com/pharmtech/Article/Market-Outlook-for-Biosimilars/ArticleStandard/Article/detail/623094?contextCategoryId=40940&ref=25 The author reviews the major biopharmaceutical markets' activity and predicts how the markets may evolve. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623094null XML Week of Aug. 24, 2009: Warner Chilcott Buys P&G Pharma Business; Amylin Appoints Former Novartis Exec As Chairman; More... http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Aug-24-2009-Warner-Chilcott-Buys-PampG-Pha/ArticleStandard/Article/detail/621551?contextCategoryId=40940&ref=25 Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more... 2009-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621551null HTML Pharma Boom in Eastern Europe http://pharmtech.findpharma.com/pharmtech/Outsourcing/Pharma-Boom-in-Eastern-Europe/ArticleStandard/Article/detail/621589?contextCategoryId=40940&ref=25 Eastern Europe's pharmaceutical market is forecast to grow at a CAGR of more than 10% to be worth more than $41 billion by 2014, according to a report from companiesandmarkets.com. 2009-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621589null HTML Businesses neglect to measure value of outsourcing http://pharmtech.findpharma.com/pharmtech/News/Businesses-neglect-to-measure-value-of-outsourcing/ArticleStandard/Article/detail/620047?contextCategoryId=40940&ref=25 Only 43% of European Chief Financial Officers (CFOs) and Chief Information Officers (CIOs) have tried to calculate the impact of outsourcing on their company, and of those that have tried, only 1 in 5 are confident in their sums, according to a study by Cognizant. 2009-08-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342009/620047null HTML Report Predicts Growth for Outsourcing to India http://pharmtech.findpharma.com/pharmtech/Manufacturing/Report-Predicts-Growth-for-Outsourcing-to-India/ArticleStandard/Article/detail/620132?contextCategoryId=40940&ref=25 India accounts for approximately 3% of the global outsourcing market, which indicates a significant opportunity for growth, according to a report published by Ernst and Young and the Organization of Pharmaceutical Producers of India. 2009-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342009/620132null HTML Company and People Notes: Forest Labs and AstraZeneca Form Pact; Endo COO Resigns; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Forest-Labs-and-AstraZene/ArticleStandard/Article/detail/620144?contextCategoryId=40940&ref=25 Also, XCELERON and GSK form agreement; Millipore appoints VP of life sciences; more... 2009-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342009/620144null HTML European Businesses Neglect to Measure Value of Outsourcing http://pharmtech.findpharma.com/pharmtech/News/European-Businesses-Neglect-to-Measure-Value-of-Ou/ArticleStandard/Article/detail/620136?contextCategoryId=40940&ref=25 Only 43% of European chief financial officers (CFOs) and chief information officers (CIOs) have tried to calculate the impact of outsourcing on their company, and of those that have tried, only 1 in 5 are confident about their calculations, according to a study by Cognizant, a global business technology company based in Teaneck, NJ. 2009-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342009/620136null HTML Regulatory Roundup: FDA Reorganizes the Office of the Commissioner, More... http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Regulatory-Roundup-FDA-Reorganizes-the-Office-of-t/ArticleStandard/Article/detail/620139?contextCategoryId=40940&ref=25 Also, FDA publishes draft guidances of two ICH Annexes; EMEA sets format for compliance advice; more... 2009-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342009/620139null HTML Company and People Notes: Nabi and GSK Form Pact; Cardinal Health Names CEO; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Nabi-and-GSK-Form-Pact-Ca/ArticleStandard/Article/detail/618405?contextCategoryId=40940&ref=25 Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more... 2009-08-13T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332009/618405null HTML FDA Issues Guidance on Monitoring At-Risk Melamine Contamination http://pharmtech.findpharma.com/pharmtech/Formulation/FDA-Issues-Guidance-on-Monitoring-At-Risk-Melamine/ArticleStandard/Article/detail/618407?contextCategoryId=40940&ref=25 The US Food and Drug Administration released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination. 2009-08-13T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/332009/618407null HTML Company and People Notes: Cherokee and DuPont Form Supply Agreement; Mylan Makes Changes in Management Team; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Cherokee-and-DuPont-Form-/ArticleStandard/Article/detail/616603?contextCategoryId=40940&ref=25 Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more... 2009-08-06T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322009/616603null HTML The Effect of Water on Low Temperature Heat Transfer Fluid Performance http://pharmtech.findpharma.com/pharmtech/Manufacturing/The-Effect-of-Water-on-Low-Temperature-Heat-Transf/ArticleStandard/Article/detail/616878?contextCategoryId=40940&ref=25 Poor performance in industrial cooling processes involving liquid nitrogen is often blamed on water contamination of the secondary coolant. This study simulated the coil freezing characteristics of 3 liquids ? Paratherm CR, silicone and a d-limonene blend ? at varying levels of water contamination. 2009-08-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/322009/616878null REMOTE For Biotherapeutics, Innovation is Not Enough http://pharmtech.findpharma.com/pharmtech/IT/For-Biotherapeutics-Innovation-is-Not-Enough/ArticleStandard/Article/detail/615816?contextCategoryId=40940&ref=25 Biotech firms must first close the gaps between science and biology on the path toward QbD. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615816null XML Preventing the Next Heparin Scare http://pharmtech.findpharma.com/pharmtech/Inside+Standards/Preventing-the-Next-Heparin-Scare/ArticleStandard/Article/detail/615819?contextCategoryId=40940&ref=25 Determined to prevent further supply-chain breaches, industry takes charge, offers proposals. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615819null XML Of Hubris and Happy Endings http://pharmtech.findpharma.com/pharmtech/IT/Of-Hubris-and-Happy-Endings/ArticleStandard/Article/detail/615813?contextCategoryId=40940&ref=25 Individuals and companies at the top seem to have no problem short-circuiting their success. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615813null XML Step Carefully into Foreign Affairs http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Step-Carefully-into-Foreign-Affairs/ArticleStandard/Article/detail/615812?contextCategoryId=40940&ref=25 As the pharmaceutical industry looks to emerging markets, corruption becomes an important issue. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615812null XML Pharma Capsules http://pharmtech.findpharma.com/pharmtech/Ingredients/Pharma-Capsules/ArticleStandard/Article/detail/615826?contextCategoryId=40940&ref=25 Brief pharmaceutical news items for August 2009. 2009-08-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615826null XML Outsourcing Stability Studies http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Outsourcing-Stability-Studies/ArticleStandard/Article/detail/615513?contextCategoryId=40940&ref=25 The author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies. 2009-08-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615513null XML The Future of Pharmaceutical CMC Outsourcing http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/The-Future-of-Pharmaceutical-CMC-Outsourcing/ArticleStandard/Article/detail/615510?contextCategoryId=40940&ref=25 A roundtable with pharma majors Pfizer and Johnson & Johnson, moderated by Jim Miller. 2009-08-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615510/outsource_new_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615510null XML Industry Outlook: Down But Not Out http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Industry-Outlook-Down-But-Not-Out/ArticleStandard/Article/detail/615618?contextCategoryId=40940&ref=25 The contract services industry may not be as robust in 2009 as it has been in previous years, but it's not as bad as many people think. 2009-08-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615618null XML Global Outsourcing: A Roundtable of Contract Manufacturers http://pharmtech.findpharma.com/pharmtech/Ingredients/Global-Outsourcing-A-Roundtable-of-Contract-Manufa/ArticleStandard/Article/detail/615507?contextCategoryId=40940&ref=25 Leading contract manufacturing organizations share their views on the current and future market dynamics shaping pharmaceutical outsourcing. 2009-08-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615507null XML Issue Extra: Executive Roundtable—The Future of Pharmaceutical CMC Outsourcing http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Issue-Extra-Executive-RoundtablemdashThe-Future-of/ArticleStandard/Article/detail/615509?contextCategoryId=40940&ref=25 A Q&A with Pfizer CentreSource, moderated by Jim Miller. 2009-08-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615509/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615509null XML Growing Pains http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Growing-Pains/ArticleStandard/Article/detail/615514?contextCategoryId=40940&ref=25 As the pharmaceutical supply chain expands, sponsor companies need to weigh all their options. 2009-08-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/615514null XML Company, People, and Regulatory Notes: Amgen and GSK Collaborate; WuXi Appoints VP of Pharmacology; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-People-and-Regulatory-Notes-Amgen-and-GSK-/ArticleStandard/Article/detail/614815?contextCategoryId=40940&ref=25 Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more... 2009-07-30T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614815null HTML Report From: China http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Report-From-China/ArticleStandard/Article/detail/614280?contextCategoryId=40940&ref=25 China's State Food and Drug Administration has completed a new draft of GMP guidelines, but after a series of quality-control events, it will take time for the country to regain the global pharmaceutical industry's trust. 2009-07-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614280/china_new_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614280/China_flash.jpg XML Outsouring: A Rapid, Cost-Effective Option for Electronic (eCTD) Submissions http://pharmtech.findpharma.com/pharmtech/Outsourcing/Outsourcing-A-Rapid-Cost-Effective-Option-for-Elec/ArticleStandard/Article/detail/614074?contextCategoryId=40940&ref=25 Pharmaceutical and biotech sponsor organizations are in increasing numbers making the switch from paper to electronic (eCTD) format for their marketing applications to FDA. Given the current difficult economic environment, sponsors, especially those with modest submission volumes, should consider outsourcing as a great option to enable the strategic benefits of eCTD while significantly reducing the barriers. 2009-07-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614074null REMOTE Company, People, and Regulatory Briefs: Teva and Ortho Extend Agreement; Biogen Idec Cofounder Retires; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-People-and-Regulatory-Briefs-Teva-and-Orth/ArticleStandard/Article/detail/612961?contextCategoryId=40940&ref=25 Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more... 2009-07-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302009/612961null HTML Topical Dermatological Formulation Development – "Things You Should Know" http://pharmtech.findpharma.com/pharmtech/Whitepapers/Topical-Dermatological-Formulation-Development-nda/ArticleStandard/Article/detail/612809?contextCategoryId=40940&ref=25 "Things You Should Know" will answer many of your questions and will provide insight into issues you may not have considered — but should be aware when developing a topical formulation. The target product profile, dosage form selection, reasons for multiple excipients, the formulation development process, prototype screening, and lead formulation selection are discussed. 2009-07-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302009/612809null REMOTE Company and People Notes: Merck and Portola Sign Agreement; Eisai Appoints Senior Vice-Presidents; More ... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Merck-and-Portola-Sign-Ag/ArticleStandard/Article/detail/611109?contextCategoryId=40940&ref=25 Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more... 2009-07-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292009/611109null HTML Company and People Notes: Pfizer and Graceway Form Deal; GeoVax Labs Leader Resigns; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Pfizer-and-Graceway-Form-/ArticleStandard/Article/detail/609491?contextCategoryId=40940&ref=25 Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more... 2009-07-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282009/609491null HTML Company and People Notes: GSK and Chroma Form Development Pact; Siemen's Healthcare Appoints US CEO; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-and-Chroma-Form-Devel/ArticleStandard/Article/detail/607999?contextCategoryId=40940&ref=25 Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more... 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607999null HTML East Meets West in Contract Biologics Manufacturing http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/East-Meets-West-in-Contract-Biologics-Manufacturin/ArticleStandard/Article/detail/607462?contextCategoryId=40940&ref=25 A joint biopharmaceutical manufacturing facility in India by Kenwell and Boehringer Ingelheim ushers in new era. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607462null XML Examining High-Potency API Manufacturing http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Examining-High-Potency-API-Manufacturing/ArticleStandard/Article/detail/607456?contextCategoryId=40940&ref=25 High-potency manufacturing of active pharmaceutical ingredients is a growing and specialized capability. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607456null XML Can Industry Learn to Share? http://pharmtech.findpharma.com/pharmtech/IT/Can-Industry-Learn-to-Share/ArticleStandard/Article/detail/607463?contextCategoryId=40940&ref=25 The regulators are doing it. But industry's fear of sharing information may leave them behind. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607463null XML The Good Society http://pharmtech.findpharma.com/pharmtech/IT/The-Good-Society/ArticleStandard/Article/detail/607467?contextCategoryId=40940&ref=25 Is it good policy to pay for bad behavior? 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607467null XML USP Collaborates with Asian Authorities http://pharmtech.findpharma.com/pharmtech/Manufacturing/USP-Collaborates-with-Asian-Authorities/ArticleStandard/Article/detail/608009?contextCategoryId=40940&ref=25 This week, the US Pharmacopeial Convention and the Vietnamese Pharmacopoeia Commission signed a memorandum of understanding that will help ensure the safety of Vietnamese medicines. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608009null HTML SCM's secrets http://pharmtech.findpharma.com/pharmtech/Online+Only/SCMs-secrets/ArticleStandard/Article/detail/604224?contextCategoryId=40940&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://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtecheurope/252009/604224null HTML Avoiding Project Delays Caused by Formulation Changes http://pharmtech.findpharma.com/pharmtech/Whitepapers/Avoiding-Project-Delays-Caused-by-Formulation-Chan/ArticleStandard/Article/detail/607230?contextCategoryId=40940&ref=25 For pharmaceutical manufacturing companies, every decision in the product development process can impact the project outcome. By working closely with a reliable Contract Research Organization, clients can take the necessary precautions to avoid risks throughout the development program. A new white paper from SP Formulations, titled "Freeze! Avoid Catastrophic Project Delays Caused by Formulation Changes", presents some of the problems associated with 'simple' formulation changes. In addition to providing guidance on outsourcing drug development needs, the white paper presents a case study detailing the alternative approaches available for formulating a lyophilized product. 2009-06-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607230null REMOTE Company and People Notes: Synta and GSK End Agreement; WuXi Appoints US VP; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Synta-and-GSK-End-Agreeme/ArticleStandard/Article/detail/606500?contextCategoryId=40940&ref=25 Also, Adimab forms deals with Merck and Roche; Manhattan Pharmaceuticals' CEO and president steps down; more... 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/606500null HTML Company and People Notes: Dr. Reddy and GSK Form Pact; Hollis-Eden Appoints CEO; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Dr-Reddy-and-GSK-Form-Pac/ArticleStandard/Article/detail/604472?contextCategoryId=40940&ref=25 Also, FDA debars clinical investigators; Jubilant Organosys forms deal with Endo Pharmaceuticals; AMRI makes changes to its India management team; more... 2009-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/604472null HTML Company and People Notes: CSL and Talecris Terminate Merger Agreement; Eli Lilly Hires Former Indianapolis Mayor; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-CSL-and-Talecris-Terminat/ArticleStandard/Article/detail/602720?contextCategoryId=40940&ref=25 Also, TorreyPines Therapeutics to liquidate assets and dissolve company; EU's competition services to examine Pfizer/Wyeth merger; Akorn appoints Raj Rai interim CEO; more... 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602720null HTML Kemwell To Build Biologics Manufacturing Facility with Boehringer Ingelheim in India http://pharmtech.findpharma.com/pharmtech/News/Kemwell-To-Build-Biologics-Manufacturing-Facility-/ArticleStandard/Article/detail/602702?contextCategoryId=40940&ref=25 Kemwell (Bangalore, Karnataka, India) plans to build a new biopharmaceutical manufacturing plant in Bangalore, India, in a strategic collaboration with Boehringer Ingelheim (BI, Ingelheim, Germany), according to a Kemwell press release. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602702null HTML Limits to Growth? http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Limits-to-Growth/ArticleStandard/Article/detail/601914?contextCategoryId=40940&ref=25 A major CRO ventures further into proprietary drug development. 2009-06-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601914null XML Bleak Times for the Global Biotech Industry http://pharmtech.findpharma.com/pharmtech/Article/Bleak-Times-for-the-Global-Biotech-Industry/ArticleStandard/Article/detail/601471?contextCategoryId=40940&ref=25 The US biotechnology industry reached aggregate profitability for the first time ever in 2008, representing the only bright spot in an otherwise dismal year for biotechnology financing and performance. 2009-06-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601471null HTML Company and People Notes: AstraZeneca and Merck Collaborate on Cancer Drug; Catalent Appoints Senior VP; More... http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-AstraZeneca-and-Merck-Col/ArticleStandard/Article/detail/601645?contextCategoryId=40940&ref=25 Also, WACKER expands Iowa facility; EMEA releases a Q&A document for PIPs; Metrics consolidates quality operations; more... 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601645null HTML Report From: Ireland http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Report-From-Ireland/ArticleStandard/Article/detail/600811?contextCategoryId=40940&ref=25 Despite its shrinking domestic economy, Ireland is determined not to let its pharmaceutical industry fade into the shadow of global recession. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600811null XML Outsourcing Clinical Trial Materials http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Outsourcing-Clinical-Trial-Materials/ArticleStandard/Article/detail/600809?contextCategoryId=40940&ref=25 CROs and CMOs expand to gain a piece of the market for clinical trial materials. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600809/rotate_ingredients_flash.jpg XML Truth and Transparency http://pharmtech.findpharma.com/pharmtech/IT/Truth-and-Transparency/ArticleStandard/Article/detail/600808?contextCategoryId=40940&ref=25 Misleading the public about their investments—be it money or medicine—is unacceptable. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600808null XML Quality Trio Takes Final Shape http://pharmtech.findpharma.com/pharmtech/Inside+Standards/Quality-Trio-Takes-Final-Shape/ArticleStandard/Article/detail/600815?contextCategoryId=40940&ref=25 FDA leaders explain the purpose and plan for ICH's three quality guidelines. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600815null XML