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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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool September 3, 2004 Charly Travers	MGI Pharma's Shopping Spree The company is filling out its drug pipeline with acquisitions.
The Motley Fool August 23, 2010 Brian Orelli	No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week.
The Motley Fool November 27, 2006 Brian Lawler	Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump.
The Motley Fool August 17, 2007 Brian Orelli	Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully.
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 July 27, 2010 Jim Mueller	3 Stocks to Play Biotech Here are three promising ideas for this exciting area.
The Motley Fool April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
The Motley Fool February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
The Motley Fool September 9, 2010 Brian Orelli	Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September.
The Motley Fool June 2, 2010 Brian Orelli	Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market.
The Motley Fool December 31, 2011 Brian Orelli	3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.
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.
The Motley Fool July 24, 2007 Brian Lawler	MGI Flies Shares of MGI Pharma rise after positive second-quarter results and a bright outlook for the coming months.
The Motley Fool January 28, 2010 Brian Orelli	How to Make a Billion Bucks in Biotech Drug companies and investors alike have to balance the risk and reward.
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 30, 2010 Brian Orelli	A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs.
The Motley Fool January 25, 2010 Brian Orelli	No Way to Hide This Drug Approval FDA trumps Acorda on its good news. The biotech announced Food and Drug Administration approval of Ampyra, its drug to help multiple sclerosis patients walk better after the markets closed on Friday.
The Motley Fool December 11, 2007 Brian Lawler	The MGI Deal Makes Sense MGI Pharma announces it is being acquired by Japanese pharma giant Eisai for $3.9 billion.
The Motley Fool January 31, 2011 Brian Orelli	5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list.
The Motley Fool February 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.
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 April 8, 2011 Brian Orelli	A Shutdown of Binary Events? A government shutdown will likely stop FDA approvals.
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 June 8, 2010 Brian Orelli	Injecting Uncertainty Into the Multiple Sclerosis Market Novartis' oral MS drug could be a blockbuster -- if it can get past the FDA.
The Motley Fool December 27, 2010 Brian Orelli	FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered.
The Motley Fool March 31, 2011 Brian Orelli	Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good.
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.
The Motley Fool January 14, 2008 Brian Lawler	Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.
The Motley Fool February 18, 2010 Brian Orelli	Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance.
The Motley Fool December 31, 2007 Brian Lawler	The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool November 14, 2007 Brian Lawler	Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years.
The Motley Fool October 19, 2010 Brian Orelli	Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency.
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 April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
The Motley Fool January 31, 2007 Brian Lawler	FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer.
The Motley Fool October 23, 2006 Brian Lawler	MGI's Anonymous Growth If there's a value stock in the pharma world, this may be it.
BusinessWeek June 12, 2006 Catherine Arnst	Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
The Motley Fool January 28, 2011 Brian Orelli	Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result.
The Motley Fool December 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
The Motley Fool October 18, 2007 Brian Lawler	MGI's Quiet Gains The specialty pharma notches a healthy third-quarter and should keep performing well into the future. Investors, take note.
CIO March 15, 2006 Allan Holmes	Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market.
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin	Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
Investment Advisor December 2005 Greg B. Scott	Buying The Future Prudent investing in biotechnology can offer great returns for clients. It's also the wave of the future. Armed with a basic understanding of the dynamics of the industry and the valuation inflection points, intelligent investors can make significant returns.
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.