Policy & Regulation: Page 22


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    The FDA

    A new law is expected to have an immediate and significant impact on the Food and Drug Administration. By Denise Myshko Tightening the Regulatory Reins The new law passed in September 2007 is expected to have an immediate and significant impact on the Food and Drug Administration’s authority over...

    By Denise Myshko • Jan. 2, 2008
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    On the Calendar

    November 15 The Pharmaceutical Business From Drug Discovery Through Product Launch Workshop The Learning Key, Washington Crossing, Pa. For more information, contact Marianne Speiser, The Learning Key, at 215-493-9641, e-mail [email protected], or visit thelearningkey.com. November 15-16...

    By PharmaVoice Team • Jan. 2, 2008
  • biotech market Explore the Trendline
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    Trendline

    Emerging biotech

    After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

    By PharmaVoice staff
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    UpFront

    Scientific Splashdown Pharma Provides Robust Level of Information According to its most recent quarterly review of scientific literature on drugs and therapies, Thomson Scientific reported that Novartis gained pole position knocking GlaxoSmithKline out of the top spot for the first time since Jun...

    By PharmaVoice Team • Jan. 2, 2008
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    Table of Contents

    Table of Contents November/December 2007 An Industry Overview To make the most of future growth opportunities, the industry must fundamentally change the way it operates. Then & Now Thought leaders review their 2006 predictions in 2007. Crystal Ball Industry experts identify the top trends th...

    By PharmaVoice Team • Jan. 2, 2008
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    The Corner Office

    A review of commentary from more than two dozen of the CEOs and Presidents of leading life-sciences companies reveals some top trends. A review of the annual reports, public statements, and exclusive commentary from almost two dozen of the industry’s pharmaceutical/biotechnology companies reveals...

    By PharmaVoice Team • Jan. 2, 2008
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    Letter from the Editor

    By Taren Grom, Editor Contemplating the year ahead As we move into 2008, it appears that there are many more questions than answers for the industry. Certainly, the upcoming presidential election is on everyone’s minds. The healthcare platforms presented by the front runners are being dissected a...

    By Taren Grom • Jan. 2, 2008
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    Salesforces

    By Taren Grom, Editor A new sales model will emerge that uses sophisticated selling techniques, technologies, and education. The Salesforce of the Future In the future, the salesforce army of today will be but a distant memory as a new sales model emerges that uses sophisticated selling technique...

    By PharmaVoice Team • Jan. 2, 2008
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    Biogenerics at a Crossroads

    By Cynthia Borda Over the past few years, several forces have begun to converge that will likely shift the entire biomarket’s dynamics. Patents of top-selling biotechnology products have lost or will lose patent protection in the next half dozen years (see chart on page 46 for more information). ...

    By Cynthia Borda • Jan. 2, 2008
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    PharmaOutlet

    Contributed by Natalie Douglas Named Patient Programs Yield Significant Results Access to information about drug development and clinical pipelines has become readily available on a worldwide basis. Physicians and patients are now more informed than ever before about innovative drugs in late-stag...

    By Natalie Douglas • Jan. 2, 2008
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    Adaption Adoption

    By Denise Myshko The double-blind, randomized, parallel group design of clinical trials is so entrenched with well-established processes and systems in the industry that to even consider a change in structure may seem like an uphill battle. But many in the pharmaceutical industry — from pharmaceu...

    By Denise Myshko • Jan. 2, 2008
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    UpFront

    An international connection Internet and Physicians in Latin America As in the rest of the world, healthcare professionals from across Latin America use the Internet to be informed, and surprisingly, a majority use their free time to do so. A recent survey by Medimix International shows that most...

    By PharmaVoice Team • Jan. 2, 2008
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    Letter from the Editor

    On behalf of the PharmaLinx LLC family, I would like to thank all of those who contributed to the success of the 7th annual charity golf event. Seven years ago, believe it or not, we — Lisa Banket, Marah Walsh, and myself — not only founded the company and began publishing PharmaVOICE but establi...

    By Taren Grom • Jan. 2, 2008
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    Managed Markets: Workers' Comp Pharmacy Costs Rising

    By Denise Myshko Total spend for drugs in the workers’ compensation arena is expected to be $5.5 billion in 2007 and represents 15% of total medical costs associated with workers’ compensation. This is the fastest growing component of the system’s medical expense. The use of generic drugs is sign...

    By Denise Myshko • Jan. 2, 2008
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Lipitor Perceived as Market Leader Among Statin Brands When it comes to statins, the most frequently discussed issue in the blogosphere and general online world is the negative side effects. This is one of the findings in a recent report fielded ...

    By PharmaVoice Team • Jan. 2, 2008
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    UpFront

    Online update SURF’s UP According to Manhattan Research’s latest study, physician site traffic is spread among product sites of new and early-launch stage treatments, those with clinical news coverage, and, consistent with years past, products with a significant consumer advertising component. “W...

    By PharmaVoice Team • Jan. 2, 2008
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    Table of Contents

    Table of Contents September 2007 On the Cover Success Beyond the Silos Innovative pharmaceutical companies are redefining the communications process by tearing down the walls between the different factions: agencies, sales, marketing, and public relations. FEATURES Postmarketing Safety in the Spo...

    By PharmaVoice Team • Jan. 2, 2008
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    E-Media

    PharmaLinx Launches Industry Web Portal Professionals who operate in the pharmaceutical, biotechnology, and medical-device sectors, as well as those who provide services and tools to the industry, now have a single source to find targeted information related to their fields. The new portal, Acces...

    By PharmaVoice Team • Jan. 2, 2008
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    DIA 2007 -- Annual Conference

    DIA Addresses extreme topics The 43rd Annual Meeting of the Drug Information Association DIA 2007 — Annual Conference The Drug Information Association’s 43rd annual meeting featured 450 sessions and more than 1,000 speakers. Industry Thought Leaders Raise their VOICE at DIA Podcasts BBK Worldwide...

    By PharmaVoice Team • Jan. 2, 2008
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    7 Rules for New War Games

    Stan Bernard of Bernard Associates says practicing competitive simulations is a better approach than war games because simulations address more of the challenges that companies face. Traditionally, businesses have engaged in war games, in which marketing groups or brand teams compete by dividing ...

    By PharmaVoice Team • Jan. 2, 2008
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    New Directions for Clinical Directors

    By Denise Myshko As drug development continues to become global and more complex, the clinical director’s role is changing as well. The function of the clinical director has broadened from a purely medical and scientific advisory role to being the clinical leader responsible for the design and de...

    By PharmaVoice Team • Jan. 2, 2008
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    Nanotech Comes of Age

    By Kim Ribbink The once futuristic science of nanotechnology has come of age and branched into a broad spectrum of applications. Among these is nanomedicine: medicinal intervention at the molecular level for curing disease, repairing damaged tissue, and monitoring biological systems. The National...

    By Kim Ribbink • Jan. 2, 2008
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    Section 199 Deduction for Qualified Production Activity Income

    In October of 2004, the U.S. Congress and President Bush signed into law the American Jobs Creation Act of 2004. The Act is the first major corporate tax act in over a decade. A key provision of the Act is a new domestic manufacturing deduction designed to improve the global competitiveness of U....

    By PharmaVoice Team • Jan. 2, 2008
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    What's New

    New Healthcare-related Products, Services, and Companies New Healthcare Marketing and Communications Agency Created The agency helps clients identify situations and places where behavior can be influenced. Identifying a need to provide clients with a way to compete more effectively in today’s dyn...

    By PharmaVoice Team • Jan. 2, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies CIS Launches Pharma Compliance Exchange Website Compliance Implementation Services (CIS) recently released the Pharma Compliance Exchange (PCX), a new subscription-based source for government guidance documentation. For the first ...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Pharma POOL Warwick S. Bedwell Roche Appoints VP and Global Head of Business Development, Pharma Partnering Warwick S. Bedwell has been appointed VP and global head of Roche Pharmaceutical’s Business Development — Pharma Partnering business. Roche, Nutley, N.J., is part of the Roche Group, a rese...

    By PharmaVoice Team • Jan. 2, 2008