http://pharmtech.findpharma.com/pharmtech A publication providing practical information on pharmaceutical manufacturing. Content focuses on applied R&D technology, process control and computer-integrated manufacturing, biotechnology and technical management. 2008-07-23T20:57:38Z http://pharmtech.findpharma.com/pharmtech/News/Company-and-People-Notes-AMRI-Opens-In-Vitro-Labor/ArticleStandard/Article/detail/531389?ref=25 Also, Niro changes its name to GEA Process Engineering; Frances K. Heller joins Exelixis as executive vice-president of business development, more... 2008-07-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302008/531389null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Roche-to-Acquire-Genentech-for-437-Billion/ArticleStandard/Article/detail/531356?ref=25 Roche plans to acquire the biopharmaceutical company Genentech (South San Francisco, CA) for $43.7 billion. Roche currently holds a 55.9% stake in Genentech and it plans to acquire the remaining publicly held minority interest that it does not own for $89 per share. 2008-07-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302008/531356null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Launches-Fellowship-Program/ArticleStandard/Article/detail/531337?ref=25 The US Food and Drug Administration seeks applicants for its new Commissioner’s Fellowship Program for scientists, engineers, and health professionals. The two-year program will help prepare the agency to replace a large number of FDA staff who are preparing to retire as well as meet future goals. 2008-07-23T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302008/531337null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Reissues-Exemption-for-Phase-I-Testing/ArticleStandard/Article/detail/531236?ref=25 The US Food and Drug Administration issued a final rule on July 18 that exempts early Phase I investigational drugs from certain good manufacturing practice regulations. 2008-07-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302008/531236null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Teva-to-Purchase-Barr/ArticleStandard/Article/detail/531227?ref=25 Teva Pharmaceutical Industries and Barr Pharmaceuticals (Montvale, NJ) signed a definitive agreement under which Teva will acquire Barr, the fourth-largest generic-drug company in the world. Teva will buy each share of Barr common stock for $39.90 in cash and 0.6272 Teva shares. Based on the closing price of Teva?s shares on July 16, 2008, the price per share of Barr common stock is $66.50, and the total value of the acquisition is $7.46 billion. Teva will assume Barr?s outstanding net debt of approximately $1.5 billion. 2008-07-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302008/531227null HTML http://pharmtech.findpharma.com/pharmtech/Formulation+Whitepaper/Developing-powder-processing-expertise-for-the-imp/ArticleStandard/Article/detail/530887?ref=25 Powder characterization techniques have improved significantly in recent decades, developing well beyond the simplistic methods traditionally used. This paper examines the changes in approach encouraged by QbD and the contribution modern powder testers can make. 2008-07-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/302008/530887null REMOTE http://pharmtech.findpharma.com/pharmtech/Comments-on-ldquoePedigree-Using-the-Gift-of-Time-/ArticleStandard/Article/detail/530504?ref=25 See reader comments on PharmTech's July 2008 Viewpoint article, "ePedigree: Using the Gift of Time Wisely." 2008-07-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/530504null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Draft-Guidance-Issued-for-Electronic-Regulatory-Su/ArticleStandard/Article/detail/530123?ref=25 The US Food and Drug Administration published a Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format in the Federal Register on July 11. 2008-07-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/530123null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Bristol-Myers-Squibb-Upgrades-Equipment-for-Clean-/ArticleStandard/Article/detail/530127?ref=25 Bristol-Myers Squibb (BMS) agreed to reduce the output of ozone-depleting refrigerants at several industrial facilities around the country to resolve violations of the Clean Air Act. The company's modifications will cost approximately $3.65 million. 2008-07-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/530127null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Solid-Microstructured-Transdermal-Delivery-Highlig/ArticleStandard/Article/detail/530138?ref=25 3M Drug Delivery Systems has successfully designed a proof of concept device using a solid microstructured transdermal system for the systemic delivery of high-potency pharmaceuticals. The technology was showcased at a poster session at the annual meeting of the Controlled Release Society held this week in New York City. 2008-07-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/530138null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Pfizer-to-Cut-275-Michigan-Jobs/ArticleStandard/Article/detail/530137?ref=25 Pfizer (New York, NY) announced plans to restructure staff at its Kalamazoo, Michigan, facility, leading to an estimated job cut of 275 by the end of the year. 2008-07-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/530137null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Solvay-Pharma-Raises-Bid-/ArticleStandard/Article/detail/530372?ref=25 Also, Roche to end HIV/AIDS research program, WuXi PharmaTech makes appointments, more... 2008-07-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/530372null HTML http://pharmtech.findpharma.com/pharmtech/Article/The-Challenges-of-Manufacturing-Nanoparticles-thro/ArticleStandard/Article/detail/529752?ref=25 Creating nanoparticles can be challenging and requires appropriate equipment and techniques. Media milling or grinding is the best-established manufacturing method for nanoparticle production. 2008-07-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529752null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/July-2008-Editors-Picks-Parker-Fluid-Control-Divis/ArticleStandard/Article/detail/529716?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the July 2008 edition from Parker Fluid Control Division and Watson-Marlow Bredel. 2008-07-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529716null HTML http://pharmtech.findpharma.com/pharmtech/Article/IT-Strategies-for-Evaluating-CMO-Performance/ArticleStandard/Article/detail/529783?ref=25 A pharmaceutical company's information-technology infrastructure could facilitate the appraisal of the performance of contract manufacturing organizations. 2008-07-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529783null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Final-Bulk-Inspection-of-Solid-Dose-Pharmaceutical/ArticleStandard/Article/detail/528922?ref=25 Final bulk inspection of solid-dose OTC and regulated pharmaceuticals must deliver consistently high product quality. Customers scrutinize products closely, and processes are increasingly coming under the review of regulatory agencies. Advanced technology addresses these challenges, as new automated continuous inspection systems are more effective and commercially viable than ever before. 2008-07-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528922null REMOTE http://pharmtech.findpharma.com/pharmtech/News/Pfizer-To-Pay-Fine-for-PharmaMACT-Violations/ArticleStandard/Article/detail/528623?ref=25 Pfizer has agreed to pay $975,000 in civil penalties to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Connecticut, according to a release by the US Department of Justice. 2008-07-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528623null HTML http://pharmtech.findpharma.com/pharmtech/News/European-Pharmacopeia-Defines-Policy-for-Potential/ArticleStandard/Article/detail/528626?ref=25 The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa. 2008-07-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528626null HTML http://pharmtech.findpharma.com/pharmtech/News/Company-and-People-Notes-Fresenius-to-Acquire-APP-/ArticleStandard/Article/detail/528672?ref=25 Also, Catalent Pharma Solutions to collaborate with One World Design and Manufacturing Group, Bioheart appoints Howard J. Leonhardt as CEO, more... 2008-07-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528672null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Opens-Pilot-Program-for-Biotech/ArticleStandard/Article/detail/528625?ref=25 The US Food and Drug Administration is seeking volunteers from the pharmaceutical industry to participate in a pilot program involving the submission of quality information for biotechnology products. 2008-07-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528625null HTML http://pharmtech.findpharma.com/pharmtech/News/European-Pharmacopeia-Adopts-Revised-Heparin-Monog/ArticleStandard/Article/detail/528624?ref=25 The European Pharmacopoeia Commission adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control. 2008-07-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528624null HTML http://pharmtech.findpharma.com/pharmtech/Enterprise-Level-Change-Control/ArticleStandard/Article/detail/527225?ref=25 Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control. 2008-07-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527225null XML http://pharmtech.findpharma.com/pharmtech/The-Economics-of-Follow-on-Biologics/ArticleStandard/Article/detail/527183?ref=25 A recent US government study shows that follow-on biologics are likely to have a favorable economic impact if proposed legislation authorizing a regulatory pathway in the US is approved. 2008-07-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527183null XML http://pharmtech.findpharma.com/pharmtech/Comments-on-Public-Service-Versus-Self-Service/ArticleStandard/Article/detail/528678?ref=25 See reader comments on Editor-in-Chief Michelle Hoffman's June 2008 editorial, "Public Service Versus Self-Service." 2008-07-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528678null HTML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Toward-a-New-Model-for-Contract-Manufacturing/ArticleStandard/Article/detail/527178?ref=25 Global manufacturing excellence will be a game changer for CMOs that can achieve it. 2008-07-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527178null XML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Containment-of-Basket-Filtration-Centrifuges/ArticleStandard/Article/detail/528299?ref=25 Basket filtration centrifuges are commonly used as a means of filtering potent compounds, and are an effective way to separate and purify solid products. As the demands to minimize operator exposure to the products increase, and as the exposure limits to solvent vapors decrease, the challenge with basket filtration centrifuges is to maintain contained transfer of the caked solids during discharge into downstream processing equipment. 2008-07-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/528299null REMOTE http://pharmtech.findpharma.com/pharmtech/News/Federal-Report-Outlines-Cost-Savings-in-Biosimilar/ArticleStandard/Article/detail/527568?ref=25 The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007. 2008-07-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527568null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Bush-Signs-Bill-Granting-FDA-150-Million/ArticleStandard/Article/detail/527573?ref=25 President Bush signed H.R. 2642, the Supplemental Appropriations Act of 2008, which provides $150 million to the US Food and Drug Administration for medical-safety and drug-safety activities. 2008-07-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527573null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Wireless-Environmental-Monitoring-Solutions/ArticleStandard/Article/detail/527826?ref=25 This paper describes the advantages of using a wireless environmental monitoring system for measuring humidity and temperature parameters in manufacturing and process industries. It explains the ease of installation procedure and answers the safety and data security concerns that often influence a purchase decision. 2008-07-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527826null REMOTE http://pharmtech.findpharma.com/pharmtech/Ingredients/Green-Route-for-Precursors-for-Suzuki-Coupling-Rec/ArticleStandard/Article/detail/527575?ref=25 Richard E. Maleczka Jr. and Milton R. Smith III, professors of the Department of Chemistry at Michigan State University, were recognized by the Environmental Protection Agency's Presidential Green Chemistry Challenge Awards, for designing a catalytic reaction to synthesize precursors for the Suzuki-coupling reaction. 2008-07-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527575null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Nanoscale-Technique-Measures-Surface-Physical-Prop/ArticleStandard/Article/detail/527577?ref=25 Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy. 2008-07-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527577null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Schering-Plough-and-Merck/ArticleStandard/Article/detail/527655?ref=25 Also, Covance and WuXi PharmaTech to form contract research joint venture in China, Covidien makes appointments to its Pharmaceutical Products and Imaging Solutions businesses, more... 2008-07-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527655null HTML http://pharmtech.findpharma.com/pharmtech/Testing+News/emUSPem-467-Residual-Solvents-Becomes-Official/ArticleStandard/Article/detail/527574?ref=25 After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 "Residual Solvents" is now official. 2008-07-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/527574null HTML http://pharmtech.findpharma.com/pharmtech/Peer-Reviewed+Research/Variables-Affecting-Reconstitution-Time-of-Dry-Pow/ArticleStandard/Article/detail/529175?ref=25 The authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529175null XML http://pharmtech.findpharma.com/pharmtech/Online+Exclusive/A-Path-to-Quality/ArticleStandard/Article/detail/529453?ref=25 A new book explains process analytical technology, drug stability, and quality. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529453/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529453null XML http://pharmtech.findpharma.com/pharmtech/Editors%27+Forum/How-to-Pay-for-it-All/ArticleStandard/Article/detail/529160?ref=25 With no economic relief in sight, industry, like all of us, is grappling with high—and new—costs. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529160null XML http://pharmtech.findpharma.com/pharmtech/In+the+Spotlight/In-the-Spotlight/ArticleStandard/Article/detail/529163?ref=25 Editors' Picks of Pharmaceutical Science & Technology Innovations 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529163null XML http://pharmtech.findpharma.com/pharmtech/Feature+Article/Compliance-Risk-Management-Using-a-Top-Down-Valida/ArticleStandard/Article/detail/529176?ref=25 Patient safety must be the primary concern of any validation effort. The author explains how a risk-based approach to validation and compliance follows naturally from this premise. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529176/70_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Washington+Report/Celebrating-25-Years-of-Orphan-Drugs/ArticleStandard/Article/detail/529164?ref=25 New scientific discoveries promise to expand treatments for rare and neglected diseases. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529164null XML http://pharmtech.findpharma.com/pharmtech/Editors%27+Forum/Talked-to-Your-Peers-Lately/ArticleStandard/Article/detail/529161?ref=25 Forums, blogs, and more can spark innovation. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529161null XML http://pharmtech.findpharma.com/pharmtech/Inside+IPEC/Dual-Use-Labeling/ArticleStandard/Article/detail/529169?ref=25 Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529169null XML http://pharmtech.findpharma.com/pharmtech/Online+Exclusive/Self-Emulsifying-Drug-Delivery-Systems/ArticleStandard/Article/detail/529471?ref=25 This review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529471/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529471null XML http://pharmtech.findpharma.com/pharmtech/Feature+Article/Tipping-the-Scales-in-Manufacturing-Investment/ArticleStandard/Article/detail/529173?ref=25 The pharmaceutical majors invest in biologics production capacity as they advance restructuring programs and build their pipelines 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529173/40_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Viewpoint/ePedigree-Using-the-Gift-of-Time-Wisely/ArticleStandard/Article/detail/529171?ref=25 The year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529171null XML http://pharmtech.findpharma.com/pharmtech/Special+Section%3A+Polymers/Improved-Mass-Determination-of-Polyethylene-glycol/ArticleStandard/Article/detail/529167?ref=25 The authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529167null XML http://pharmtech.findpharma.com/pharmtech/Article/A-Reality-Check-on-Emerging-Markets/ArticleStandard/Article/detail/529165?ref=25 Recent reports discuss the future of pharma's emerging markets. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529165null XML http://pharmtech.findpharma.com/pharmtech/Article/Deviations-and-Delays/ArticleStandard/Article/detail/529162?ref=25 They may have seemed harmless at first, but these ideas took a big bite. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529162null XML http://pharmtech.findpharma.com/pharmtech/Feature+Article/The-Benefits-and-Challenges-of-PEGylating-Small-Mo/ArticleStandard/Article/detail/529168?ref=25 Polyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529168/88_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/In+the+Field/Report-From-The-Netherlands/ArticleStandard/Article/detail/529172?ref=25 A growing preference for public-private patnerships is spurring innovation and technology among Dutch pharmaceutical companies. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529172null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Help-Your-Contract-Laboratory-Help-You/ArticleStandard/Article/detail/529170?ref=25 Providing the right information upfront may ease new requirements to assess solvent levels. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529170null XML http://pharmtech.findpharma.com/pharmtech/Special+Report/Manufacturing-Insights-Pfizer/ArticleStandard/Article/detail/529174?ref=25 Natale S. Ricciardi, president of Pfizer Global Manufacturing and senior vice-president of Pfizer, discusses the company's new manufacturing focus that features plant network optimization, increased outsourcing, and greater adoption of agile or lean manufacturing. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529174null XML http://pharmtech.findpharma.com/pharmtech/Special+Section%3A+Polymers/Excipients-in-Polymeric-Drug-Delivery-and-Formulat/ArticleStandard/Article/detail/529177?ref=25 A roundtable with John Doney, Jiao Yang, Hans Baer, and Elena Draganoiu. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529177null XML http://pharmtech.findpharma.com/pharmtech/In+the+Field/Coming-Down-the-Pike-Protein-Substrate-Binding/ArticleStandard/Article/detail/529446?ref=25 Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529446null XML http://pharmtech.findpharma.com/pharmtech/In+the+Field/Trends-Industry-Job-Cuts/ArticleStandard/Article/detail/529447?ref=25 Staff reductions are not surprising with the state of the economy and falling pharmaceutical sales. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/292008/529447null XML http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Charting-API-Market-Growth-and-Opportunity/ArticleStandard/Article/detail/529166?ref=25 The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio. 2008-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/282008/529166null XML http://pharmtech.findpharma.com/pharmtech/Online+Only/House-Subcommittee-Approves-21-Billion-for-FDA/ArticleStandard/Article/detail/526064?ref=25 The US Food and Drug Administration will have a $2.1 billion budget next year if the fiscal year 2009 bill markup by the US House of Representatives' Agriculture Appropriations Subcommittee passes through Congress. 2008-06-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262008/526064null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Company-and-People-Notes-Merck-to-Expand-North-Car/ArticleStandard/Article/detail/526093?ref=25 Also, Stiefel Laboratories will acquire Barrier Therapeutics, Danube Pharmaceuticals appoints Brian Levy COO, more... 2008-06-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262008/526093null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/USP-Posts-Revised-Heparin-Monographs/ArticleStandard/Article/detail/526062?ref=25 The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website. 2008-06-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262008/526062null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Study-Tests-Antibody-Coated-Nanotubes-and-NIR-Ligh/ArticleStandard/Article/detail/526059?ref=25 Biomedical researchers at UT Southwestern Medical Center and nanotechnology scientists at UT Dallas are collaborating on a study that seeks to selectively kill cancer cells using monoclonal antibodies to coat carbon nanotubes that heat up when exposed to near-infrared (NIR) light. 2008-06-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262008/526059null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Bayer-Advances-Protein-Production-from-Tobacco-Pla/ArticleStandard/Article/detail/526053?ref=25 Bayer and its subsidiary Icon Genetics (Halle, Germany) have developed a production process to produce therapeutic proteins from tobacco plants. 2008-06-26T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262008/526053null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Scale-up-of-Liquid--Liquid-Centrifuges/ArticleStandard/Article/detail/525749?ref=25 Centrifugal contactors are one of the technologies employed for liquid / liquid separation and liquid / liquid extraction processes. Every liquid / liquid system has its own specific characteristics and in order to successfully predict behavior, testing must be performed with small scale equipment to predict industrial performance. Process intensification studies can be performed using laboratory scale centrifugal contactors to evaluate these parameters. Pilot scale testing is performed with larger equipment to perform more thorough and specific testing. 2008-06-24T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262008/525749null REMOTE http://pharmtech.findpharma.com/pharmtech/Online+Only/HHS-Targets-FDAs-Generic-Drug-Reviews/ArticleStandard/Article/detail/524761?ref=25 With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process. 2008-06-19T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524761null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/FDA-EMEA-Consider-Seven-New-Toxicity-Tests/ArticleStandard/Article/detail/524764?ref=25 The US Food and Drug Administration and the European Medicines Agency will collaborate in efforts that would allow drug companies to submit results of seven new drug-safety tests. 2008-06-19T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524764null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-SAFC-Biosciences-to-Colla/ArticleStandard/Article/detail/524944?ref=25 Also, Patheon to expand Puerto Rico facility, Creabilis Therapeutics appoints Tony Wilson CEO, more... 2008-06-19T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524944null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/OGD-Requires-Residual-Solvent-Data-in-ANDAs/ArticleStandard/Article/detail/524748?ref=25 Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents. 2008-06-19T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524748null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Senator-Probes-into-Pharmaceutical-Outsourcing-Pra/ArticleStandard/Article/detail/524757?ref=25 Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing. 2008-06-19T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524757null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Selecting-the-Best-Conveyor-for-Your-Application/ArticleStandard/Article/detail/524217?ref=25 To choose the appropriate conveying system, a pharmaceutical manufacturer needs a thorough knowledge of the benefits and limitations of each conveyor type. The following overview compares several types of systems. 2008-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524217null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/The-Future-of-Disposable-Containment/ArticleStandard/Article/detail/524215?ref=25 Manufacturers have stopped seeing disposable containment as an ad hoc solution, and the technology increasingly incorporates thoughtful design and engineering. The future promises to bring more changes and new applications for disposable containment technology. 2008-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524215null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/June-2008-Editors-Picks-Esco-Technologies-and-Hawk/ArticleStandard/Article/detail/524210?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the June 2008 edition: Esco Technologies and Hawk Measurement 2008-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252008/524210null HTML http://pharmtech.findpharma.com/pharmtech/Industry-Employment-Factoids/ArticleStandard/Article/detail/526838?ref=25 See statistics from Pharmaceutical Technology's annual employment survey and how those compare with national trends. 2008-06-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/526838null PDF http://pharmtech.findpharma.com/pharmtech/Industry-Events-for-2008ndash2009/ArticleStandard/Article/detail/526786?ref=25 This section from PharmTech's 2008 Industry Almanac features upcoming events for 2008 and 2009. 2008-06-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/526786null PDF http://pharmtech.findpharma.com/pharmtech/Approved-New-Molecular-Entities/ArticleStandard/Article/detail/526791?ref=25 This section lists the approved new molecular entities from Jan. 2007 through May 2008. The company names, brand names, indications and molecular structures are included. 2008-06-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/526791null PDF http://pharmtech.findpharma.com/pharmtech/Top-50-Manufacturing-Pharmaceutical-Companies/ArticleStandard/Article/detail/526833?ref=25 This list of the top 50 pharmaceutical companies for 2007 is based on global sales. It includes each company's 2007 sales and shows the change from 2006. 2008-06-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/526833null PDF http://pharmtech.findpharma.com/pharmtech/Industry-and-Trade-Associations/ArticleStandard/Article/detail/526834?ref=25 This section provides contact information for important industry and trade associations worldwide. 2008-06-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/526834null PDF http://pharmtech.findpharma.com/pharmtech/iPharmaceutical-Technologyi-Article-Index/ArticleStandard/Article/detail/526840?ref=25 The magazine's articles (June 2007 to June 2008) are listed by type and topic. 2008-06-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/526840null PDF http://pharmtech.findpharma.com/pharmtech/Regulatory-Governmental-amp-Standards-Organization/ArticleStandard/Article/detail/526835?ref=25 This section provides contact information for important regulatory, governmental and standards organizations worldwide. 2008-06-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272008/526835null PDF http://pharmtech.findpharma.com/pharmtech/Online+Only/Company-and-People-Notes-Daiichi-Sankyo-to-Acquire/ArticleStandard/Article/detail/523195?ref=25 Also, Shire voluntarily recalls ADHD patch Daytrana 2008-06-12T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523195null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/ICH-Q10-Moves-to-Final-Stage-International-Adoptio/ArticleStandard/Article/detail/523172?ref=25 The steering committee of the International Conference on Harmonization and its expert working groups adopted Quality Guideline Q10 "Quality Systems" last week at a meeting in Portland, Oregon. 2008-06-12T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523172null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/EMEA-Report-Assesses-Contaminated-Heparin-Risk/ArticleStandard/Article/detail/523176?ref=25 In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely. 2008-06-12T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523176null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/European-Chemicals-Agency-Begins-REACH-Implementat/ArticleStandard/Article/detail/523175?ref=25 The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1. 2008-06-12T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523175null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Researcher-Disqualifications-on-the-Rise-Despite-C/ArticleStandard/Article/detail/523178?ref=25 The number of clinical-trial investigators overstepping their bounds has grown in the past few years. And, says Congress, the US Food and Drug Administration is taking too long to wrap up unresolved cases. 2008-06-12T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523178null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/A-Guide-to-Near-Infrared-Spectroscopic-Analysis-of/ArticleStandard/Article/detail/523519?ref=25 Near-infrared (NIR) spectroscopy is a simple, quick (<10 second analysis time), non-destructive technique that provides multi-constituent analysis on virtually any matrix with levels of accuracy and precision that are comparable to primary reference methods. NIR analyses require no sample preparation or manipulation and no reagents. This guide provides a practical overview of the critical factors that are useful and necessary when developing and implementing NIR spectroscopic methods of analysis in pharmaceutical and chemical manufacturing operations. 2008-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523519null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/In-Situ-Monitoring-of-CHO-Cell-Culture-Medium-Usin/ArticleStandard/Article/detail/523510?ref=25 NIR spectroscopy using specialized transmission probes and fiber optics allows real-time in situ analysis of bioreactor feed stocks and product. With continuous NIR analysis, metabolic parameters and culture media constituents can be better monitored and controlled, which increases CHO cell life and lengthens the production phase. 2008-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523510null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/In-line-Process-Analysis-of-Residual-Moisture-in-a/ArticleStandard/Article/detail/523514?ref=25 The authors describe the in-line moisture measurement of a pharmaceutical granulation of lactose, microcrystalline cellulose and crospovidone in a fluid bed granulator-dryer using top sprayed granulating liquid. A Near-Infrared (NIR) prediction model was developed for moisture on spectra collected during a calibration run. Subsequent granulations were analyzed for moisture content real-time throughout the granulation and drying process using the FOSS NIR process instrument. 2008-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523514null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/Near-Infrared-Assay-and-Content-Uniformity-of-Tabl/ArticleStandard/Article/detail/523511?ref=25 Near-Infrared (NIR) technique for the determination of content uniformity of tablets provides a fast and accurate means of monitoring tablet production that is in step with the FDA Process Analytical Technology (PAT) initiatives. The FOSS XDS MasterLab™ was used to determine the content uniformity of tablets, instrument precision and accuracy. The data showed promising results that could relieve laboratory workload from HPLC analysis and bring analysis closer to "real-time" for process monitoring. 2008-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523511null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/Monitoring-Granulation-Drying-using-Near-Infrared-/ArticleStandard/Article/detail/523516?ref=25 In situ analysis of residual moisture and methanol using Near-Infrared (NIR) Spectroscopy. A novel probe design can reduce the powder-sample density variance such that moisture and solvent levels can be accurately modeled and predicted in process. NIR can monitor low levels of residual moisture, alcohol and other process constituents to yield better process control and quality management. 2008-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242008/523516null REMOTE http://pharmtech.findpharma.com/pharmtech/Formulation/Assessing-powder-stability/ArticleStandard/Article/detail/522282?ref=25 Some powders appear inherently variable, sensitive to the slightest change in conditions, while others are much more forgiving. Stability testing assesses this critical aspect of powder behavior. 2008-06-06T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/522282null REMOTE http://pharmtech.findpharma.com/pharmtech/Regulation+News/FDA-Issues-Structured-Product-Labeling-Guidance-Sa/ArticleStandard/Article/detail/521245?ref=25 The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research will begin indexing structured product labeling in the product labeling for human drug and biologic products. 2008-06-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/521245null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/California-Senate-Passes-Bill-That-Would-Amend-the/ArticleStandard/Article/detail/521455?ref=25 The California Senate passed SB 1096 on May 29, voting to amend the state?s Confidentiality of Medical Information Act to allow pharmacies to provide third parties with patient information for the purpose of mailing prescription refill reminders and drug information directly to patients. 2008-06-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/521455null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/SOCMA-Weighs-in-on-Proposed-Legislation-on-Global-/ArticleStandard/Article/detail/521466?ref=25 The Synthetic Organic Chemical Manufacturers Association is evaluating proposed legislation, The Climate Security Act of 2008 (S. 3036), which directs the Environmental Protection Agency to establish a program for decreasing greenhouse emissions. 2008-06-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/521466null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/FDA-Urges-Early-Switch-to-HFA-Propelled-Albuterol-/ArticleStandard/Article/detail/521242?ref=25 The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008. 2008-06-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/521242null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-BMS-to-Acquire-Kosan-L-Pa/ArticleStandard/Article/detail/521822?ref=25 Also, Pall plans expansion in South America, Anthony Clarke joins Alexza Pharmaceuticals, more... 2008-06-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/521822null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-EMEA-and-European-Commission-Set-First-Goals-i/ArticleStandard/Article/detail/521462?ref=25 The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council, held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union. 2008-06-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/521462null HTML http://pharmtech.findpharma.com/pharmtech/Article/European-Commission-Seeks-to-Tighten-the-API-Suppl/ArticleStandard/Article/detail/519118?ref=25 As part of a larger effort to address drug counterfeiting, the European Commission is seeking to tighten manufacturing and related supply-chain requirements for active pharmaceutical ingredients. 2008-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222008/519118null HTML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/CMOs-are-Planning-for-the-Last-War/ArticleStandard/Article/detail/519119?ref=25 CMO business models are out of touch with current pharma industry realities. It's time for new thinking. 2008-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222008/519119null XML http://pharmtech.findpharma.com/pharmtech/Article/Global-and-US-Biotech-Markets-Show-Strength/ArticleStandard/Article/detail/519117?ref=25 The global and US biotechnology industries performed well in 2007 as each recorded higher revenues and inched toward aggregate profitability. 2008-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222008/519117null HTML http://pharmtech.findpharma.com/pharmtech/Online+Exclusive/Innovations-at-INTERPHEX-Part-2/ArticleStandard/Article/detail/522137?ref=25 New products for sterile filling, quality control, and anticounterfeiting measures gained notice. 2008-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/522137/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/522137null XML http://pharmtech.findpharma.com/pharmtech/Editors%27+Forum/Public-Service-Versus-Self-Service/ArticleStandard/Article/detail/522123?ref=25 The good, the bad, and the ugly about direct-to-consumer advertising. 2008-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/522123null XML http://pharmtech.findpharma.com/pharmtech/Editors%27+Forum/PDA-Takes-On-Risks-for-Patients/ArticleStandard/Article/detail/522124?ref=25 Risk management, and its benefits for patients, plays a big role at the PDA Annual Meeting. 2008-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/522124null XML http://pharmtech.findpharma.com/pharmtech/Article/The-Use-of-Complaining/ArticleStandard/Article/detail/522125?ref=25 Customers complaining lead to some serious explaining. 2008-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232008/522125null XML