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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 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 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 November 30, 2010 Brian Orelli	A Witty Response to Pharma's R&D Dilemma According to GlaxoSmithKline CEO Andrew Witty, the pharmaceutical industry is a mess. That's the basic gist of his opinion piece in The Economist.
The Motley Fool February 28, 2011 Brian Orelli	Rare Diseases, Big Opportunity "Orphan" drugs to keep your eye on.
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 August 31, 2010 Brian Orelli	Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior.
The Motley Fool November 15, 2007 Brian Orelli	John Edwards' Not-So-Bad Plan John Edwards' plan to take away drug patents in exchange for a monetary price just may work, if the price is high enough.
The Motley Fool March 3, 2009 Brian Orelli	Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think.
The Motley Fool September 12, 2005 M.D. Mitchell	Big Problems for Big Pharma Creating new drugs is never easy, but the companies that excel in three key areas are the ones for investors to watch.
The Motley Fool March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
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 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 September 15, 2010 Brian Orelli	Drug Approved. Now Let's Sell This Baby! With ink still wet on its FDA approval, Savient continues its plan to find a buyer.
BusinessWeek May 27, 2010 Michelle Cortez	Karo Bio's Prescription: Cheaper Drug Approval A Swedish company seeks a lower-cost review for its cholesterol drug.
The Motley Fool January 29, 2010 Brian Orelli	How to Make Billions of Dollars Without Really Trying Lackluster Alzheimer's drugs have been doing it for years.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
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 March 31, 2010 Brian Orelli	When One Patent Means So Much The loss of patents on genes could have far-reaching consequences for drug companies.
The Motley Fool May 26, 2011 Brian Orelli	Congress Sets Bad Precedent With AVANIR What happened to free markets?
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 June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
The Motley Fool October 25, 2010 Brian Orelli	Arena's Boring News The Food and Drug Administration turned down Arena Pharmaceuticals' obesity drug, lorcaserin. Tell us something we didn't know.
The Motley Fool November 29, 2010 Brian Orelli	There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain.
The Motley Fool January 21, 2011 Brian Orelli	Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir.
The Motley Fool September 23, 2008 Brian Lawler	Will Generic Biologics Get Special Treatment? While the rest of the market was lost in the financial meltdown, a little-noticed report discussing some of the biopharmaceutical bills going through Congress was released.
The Motley Fool May 20, 2010 Brian Orelli	FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down.
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.
The Motley Fool February 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.
Pharmaceutical Executive July 30, 2007 Jill Wechsler	Washington Report: Exclusivity vs. Patents To encourage innovation while supporting access to less costly therapies, Congress proposes an extensive data-exclusivity period that would delay Food and Drug Administration approval of a follow-on biologic application for 12 years.
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 October 8, 2007 Brian Orelli	New FDA Regulations for Drugmakers To deal with a growing backlog of pending applications, the FDA plans to stop its first-come, first-served system.
The Motley Fool May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
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 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 December 12, 2007 Brian Lawler	Patent Bill Is No Panacea A new bill that was meant to strengthen the patent and other intellectual-property rights of drugmakers doesn't do enough to encourage pharma innovation.
Chemistry World September 24, 2010 Andrew Turley	End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use.
The Motley Fool November 1, 2010 Brian Orelli	Stock Doubles! No Crying Here AVANIR Pharmaceuticals' investors didn't have any uncontrolled crying on Friday when the Food and Drug Administration approved Nuedexta, the company's treatment for pseudobulbar affect.
The Motley Fool December 29, 2009 Brian Orelli	Some Brand-Name Patents: Going, Going, Gone in 2010 Generic drug competition is coming for Lipitor, Plavix, and others.
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 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 April 14, 2011 Brian Orelli	Human Genome Sciences Will Be Profitable, Eventually With its first drug on the market -- nearly 20 years after the company was founded -- Human Genome Sciences should start to show meaningful revenue this year.
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 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.
Chemistry World August 23, 2012 Dean Baker	Monopoly money It is remarkable that the system of patent support for prescription drug research has not become more of a policy issue.
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 April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
The Motley Fool September 9, 2010 Jim Mueller	Today's Buy Opportunity: Teva Pharmaceutical Take advantage of this growing generic-drug maker.
The Motley Fool March 3, 2011 Brian Orelli	3 Cheers for an FDA Rejection German drugmaker Merck said that the Food and Drug Administration had turned down its multiple sclerosis drug cladribine. The pill would have competed with Novartis' Gilenya, which gained FDA approval last year.
The Motley Fool July 28, 2010 Jordan DiPietro	3 Biotechs on Your Radar Screen It's not easy keeping track of all the drugs coming in and out of the development pipeline, but if you can stay up to date, you often have an advantage