Policy & Regulation: Page


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    PharmaCase

    Common to many nonprofits is the develop ment of national publiceducation initiatives or cam paigns to enhance awareness about particular health issues. Often,these campaigns are supported by educational grants from pharmaceutical compa nies. Partnerships with nonprofits are important to pharmace...

    By PharmaVoice Team • April 16, 2008
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    Opinions

    6 J un e 20 03 PharmaVOICE WHAT’S on your mind Breadth and depth I find that industry associations do an excellent job in providing networking, pro fessional continuing education, industry rela tions, and businessdevelopment resources. I can’t speak highly enough about the breadth and depth of op...

    By PharmaVoice Team • April 16, 2008
  • Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
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    Drugs For Seniors Take Center Stage

    ever there was a political hot pota to, a Medicare drug benefit is it. For at least a dozen years now, there has been much debate — but little consensus — on how such a benefit for Medicare beneficiaries should be structured and financed. Senior cit izens, politicians, healthcare, and pharmaceu t...

    By Denise Myshko • April 16, 2008
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    25 Years of the Orphan Drug Act

    Synthetic drugs accounted for 62% of total orphan drug approvals, and synthetic polypep tides and hormones together accounted for 6%. Among biologics, growth hormones and growth factors together have the largest num ber of approvals at 8% of the total. Market approvals received for plasma product...

    By Cynthia Borda • March 27, 2008
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    Global Opportunities

    According to Ernst & Young, the sheer volume and growing economic muscle of consumers in emerging markets provide powerful investment incentives for multinational companies (MNCs). In particular, current and projected growth rates for pharmaceutical markets in the BRIC countries and Mexico ex...

    By Robin Robinson • March 2, 2008
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    User Fees: Devising a Shift in Policy

    BY DENISE MYSHKO New laws and regulations aimed at improving reviews of medical devices have been put in place. In September 2007, President George W. Bush signed a broadranging bill that expands the regulatory authority of the Food and Drug Administration. Combined with the legislation were seve...

    By Denise Myshko • March 2, 2008
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    Managing Investigator Initiated Trials

    Investigator initiated trials (IITs) can be a valuable part of a pharmaceutical or medical device manufacturer’s marketing claims arsenal, according to Rita Numerof, Ph.D., president, and Mark Morgan, M.S., senior business analyst, at Numerof & Associates Inc. The two contend that IITs are re...

    By PharmaVoice Team • Jan. 30, 2008
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    Gene Therapy Research Makes Progress

    With all the progress that has been made in genomics, targeting therapies to correct the defective genes responsible for disease seems quite realistic. But developing commercial gene therapies to treat diseases through modifying the expressions of an individual’s genes or correcting abnormal gene...

    By Denise Myshko • Jan. 29, 2008
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    UpFront

    THE PRICE IS RIGHT Drug Pricing Decisions More Critical Than Ever In aneraofmore competition from generics, expiring patent protection for many topselling drugs, and a slowdown in new drug discoveries, there is very little margin for error in drug pricing decisions. Kalorama Information’s recent ...

    By PharmaVoice Team • Jan. 29, 2008
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    Letter from the Editor

    Wh o w o u l d h a v e thought that in 10 short years, we would have gone from Dolly to Elsie? In February 1997, scientists in Scotland announced the birth of the world’s first successfully cloned mammal, Dolly the sheep. Dolly, which was created at the Roslin Institute in Edinburgh, was actually...

    By Taren Grom • Jan. 29, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies Thomson Scientific Offers Data Platform for Researchers Thomson Scientific has released BONDplus, an integrated, Web-based data platform designed to deliver real-time, comprehensive public and proprietary biological sequence, inte...

    By PharmaVoice Team • Jan. 2, 2008
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    Last Word

    Internationally renowned vaccines, immunology, and virology expert Paul A. Offit, M.D., has dedicated his career to discovering vaccines to prevent infectious diseases, and is the co-inventor of the rotavirus vaccine, RotaTeq, developed by Merck. A pediatrician, author, and scientific researcher,...

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

    New Healthcare-related Products, Services, and Companies inVentiv Health Creates Patient Outcomes Segment New division combines capabilities that help patients achieve optimum health. inVentiv Health has launched inVentiv Patient Outcomes, a business segment focused on helping pharmaceutical comp...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Executive Appointments and Promotions Pharma POOL Dr. Corey Goodman Dr. Martin Mackay Dr. Briggs Morrison Pfizer Announces Executive Changes Pfizer has launched an independent, stand-alone biotherapeutics and bioinnovation center under the direction of scientist and entrepreneur Corey Goodman, Ph...

    By PharmaVoice Team • Jan. 2, 2008
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    On the Calendar

    Industry Events January 2008 January 15-16 2nd Annual Medical Science Liaison Skill Set Training Doubletree Hotel Philadelphia, Philadelphia For more information, contact Andrea Chadis, Center for Business Intelligence, at 781-939-2428, e-mail [email protected], or visit cbinet.com. January 15-...

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

    What’s New New Healthcare-related Products, Services, and Companies CommonHealth Seeks to Enhance Healthcare with Launch of EvoLogue The agency is focusing on evolving the healthcare dialogue. CommonHealth Consumer Group (CCG) has launched EvoLogue, a full-service consumer agency providing insigh...

    By PharmaVoice Team • Jan. 2, 2008
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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
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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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    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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    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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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Pharmacists Could Impact $145 Billion in Drug Sales in Five Years One state, Florida, already allows pharmacists to independently prescribe prescription drugs, and new research suggests six other states may soon give pharmacists this pow...

    By PharmaVoice Team • 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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    When the Stars Align

    By Robin Robinson The practice of using celebrities in marketing campaigns has not lost its luster, but the pharma industry is more selective in choosing icons who match brand images. As the industry approaches the 10th anniversary of the FDA’s ruling to allow DTC and subsequently the industry’s ...

    By Robin Robinson • Jan. 2, 2008