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Pharmaceutical Executive May 1, 2006 Madison, Chan & Seeger	Making the Link The FDA recognizes that a new drug standard must evolve -- one of routine, proactive safety surveillance. But post-marketing safety studies are too slow. Here's how pharmaceuticals are using claims databases to solve the problem.
Bio-IT World November 19, 2004 Mark D. Uehling	Safety Last? Antiquated reporting of adverse events in clinical trials is costing pharma billions and forcing it to seek new pharmacovigilance solutions.
The Motley Fool February 16, 2010 Brian Orelli	For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward.
The Motley Fool September 14, 2010 Luke Timmerman	Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug.
The Motley Fool March 28, 2011 Brian Orelli	Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news.
The Motley Fool June 3, 2011 Brian Orelli	FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully.
The Motley Fool March 29, 2010 Brian Orelli	Look for Companies That Strike First Head-to-head trials, whether they're run by companies or by third parties, can be scary. But the way to make big money is by selling drugs that offer superior benefits, so investors should welcome the onslaught of upcoming comparative trial data.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
The Motley Fool May 21, 2010 Brian Orelli	And You Thought Biotech Was High-Risk, High-Reward Large clinical trials make cardiovascular drugs risky, but the rewards are there, too.
The Motley Fool March 16, 2011 Brian Orelli	Different Name, Same Great Results Incyte and Novartis' ruxolitinib passes another clinical trial.
The Motley Fool September 8, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
The Motley Fool April 26, 2011 Brian Orelli	We Hate Your Drug. And That's a Good Thing. This one's a pain for the clinical trial participants.
The Motley Fool July 12, 2010 Ryan McBride	Synta Pharma CEO Trumpets New Top Cancer Drug Synta Pharmaceuticals has been climbing back from one of the Boston area's highest-profile clinical trial failures of 2009.
The Motley Fool June 25, 2010 Brian Orelli	Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review.
Bio-IT World August 13, 2002 Mark D. Uehling	Clinical Trial Data Management: Tortured by Paper Reams of paper stuffed into boxes and shipped to the FDA by the truckload is hardly the best approach to drug approval. But what's the right way?
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool May 31, 2011 Brian Orelli	5 Biotechs With Upcoming Clinical Trial Results Investors willing to stay in these stocks a little while could see substantial gains well ahead of FDA approvals.
The Motley Fool August 9, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
The Motley Fool July 27, 2010 Jim Mueller	3 Stocks to Play Biotech Here are three promising ideas for this exciting area.
The Motley Fool May 17, 2010 Luke Timmerman	Vertex Awaits Final Proof that Hepatitis C Drug Works For this drug researcher, the proof is in the telaprevir.
The Motley Fool April 26, 2011 Luke Timmerman	FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex?
The Motley Fool August 31, 2010 Brian Orelli	Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior.
The Motley Fool March 8, 2010 Brian Orelli	Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting.
The Motley Fool April 16, 2010 Brian Orelli	It'll Be a Blockbuster! High Fives All Around, Right? Sanofi-aventis releases top-line data for its phase 3 diabetes drug candidate, lixisenatide. The trial was a success, but don't pencil it in as a blockbuster just yet.
The Motley Fool August 9, 2010 Luke Timmerman	Affymax Lives to Fight Another Day Affymax takes on Amgen with its anemia drug.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
The Motley Fool February 28, 2011 Brian Orelli	Look Out for Big Growth From This Drug Regeneron's ultra-orphan drug Arcalyst takes a step forward toward a wider audience.
The Motley Fool February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
Pharmaceutical Executive March 1, 2011 Jill Wechsler	New Tools Track Safety, Value in Medicine FDA's Sentinel Initiative raises broader questions about tapping patient information and health IT for comparative studies in drug development.
The Motley Fool January 3, 2011 Brian Orelli	Clinical Trial Results Fail to Inspire Inspire Pharma gets cut in half after a cystic fibrosis trial failure.
Bio-IT World August 13, 2003 John Rhodes	Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert.
The Motley Fool January 21, 2010 Brian Orelli	Here's That Critical Merck Info You Missed Announcing clinical trial failures in a FAQ? Really?
The Motley Fool September 7, 2010 Luke Timmerman	Vertex Nails Third Big Trial With Hepatitis C Drug And in the toughest patients to treat, too.
The Motley Fool July 29, 2010 Brian Orelli	This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either.
Pharmaceutical Executive June 1, 2006 Jill Wechsler	Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.
Chemistry World June 26, 2012 Sarah Houlton	Roche rapped for side-effect reporting failure Roche has been rapped by the European Medicines Agency for failing to report a large number of potential drug side-effects. The UK's Medicines and Healthcare products Regulatory Agency identified deficiencies in the company's medicine safety reporting system.
Chemistry World July 16, 2010 Matt Wilkinson	Bittersweet victory for GSK's Avandia GlaxoSmithKline has received a muted 'thumbs up' from a US regulatory advisory panel for its much-maligned Type 2 diabetes drug Avandia (rosiglitazone), making it likely the US Food and Drug Administration will allow the UK-based pharma giant to continue selling the drug in the US.
The Motley Fool September 8, 2010 Brian Orelli	You Must Realize This Drug Works by Now Vertex concludes its phase 3 trials with another win.
Bio-IT World December 15, 2003 Mark D. Uehling	Model Patient Despite the FDA's new support for computational modeling, the pharmaceutical industry remains cautious about simulating clinical trials.
The Motley Fool November 13, 2009 Brian Orelli	Questioning Pfizer's Integrity Pfizer's epilepsy drug Neurontin has had generic competition for a few years, but it's still plaguing the pharmaceutical giant.
The Motley Fool May 11, 2010 Ryan McBride	Clinical Data Seeks to Challenge Lilly, Pfizer in Antidepressant Market The tiny drug developer has no problem going up against bigger rivals.
The Motley Fool September 20, 2010 Brian Orelli	Potential Blockbuster, No Me-Too About It A diabetes-fighting duo do it right this time.
The Motley Fool May 27, 2011 Brian Orelli	Don't Believe the Obesity Hype Meta-analysis data isn't going to help Arena Pharmaceuticals' obesity drug.
Managed Care July 2005 Martin Sipkoff	Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules.
The Motley Fool June 18, 2010 Brian Orelli	Hot Dog! No Competition for Now Roche's diabetes pipeline drug is delayed.
Bio-IT World October 2005 Mark D. Uehling	Phase Forward Acquires Lincoln Technologies As the most intriguing clinical trial technology deal of the year, the acquisition demonstrates both Phase Forward's financial resources and the appeal of Lincoln Technologies' Java- and Web-based tools for the analysis and visualization of drug safety.
Pharmaceutical Executive September 1, 2011 Richard Gliklich	The Power of Observation Observational studies present a compelling real-world corollary to the classic randomized clinical trial.
BusinessWeek December 13, 2004 John Carey	How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs.
The Motley Fool December 3, 2010 Brian Orelli	Obesity Drug Companies Are (Still) Risky Orexigen heads before an FDA panel.
The Motley Fool April 25, 2011 Luke Timmerman	Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it?