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The Motley Fool August 6, 2007 Brian Orelli	Congress' Delay May Hurt Drugmakers The reauthorization of the Prescription Drug User Fee Act is delayed. If you're an investor in drug companies, now might be a good time to call your representatives and senators.
The Motley Fool August 21, 2007 Brian Orelli	Pushing Pills Spending on drug lobbying increases. What do companies have to show for it? The key for investors is to find drug companies that are spending their money wisely.
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 March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
The Motley Fool September 18, 2007 Brian Orelli	PDUFA Reauthorization: Almost There Much to the applause of drug makers and those who invest in them, the Prescription Drug User Fee Act reauthorization looks like it could come out of a Congressional conference committee as early as this week.
The Motley Fool June 25, 2007 Brian Orelli	Leading the Pack of Follow-On Drug Makers Generic drug maker Dr. Reddy's Laboratories is taking a huge risk to get ahead of the pack, but it's well worth the rewards of being in front of its competitors. Investors, take note.
The Motley Fool November 30, 2007 Brian Orelli	Clinical Trial Failures Don't Bother These Companies Contract research organizations, outsourcing companies hired by pharmaceutical and biotech companies to run pre-clinical tests and clinical trials for them, succeed even when drugs fail, and more work may be coming their way.
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 February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
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 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, 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 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 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 December 4, 2007 Brian Orelli	An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications.
The Motley Fool April 29, 2008 Brian Orelli	Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month.
The Motley Fool September 29, 2011 Brian Orelli	Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA.
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 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 August 22, 2007 Brian Orelli	Regulating the Drug Pushers The FDA might get a little tougher on drug ads, following a report that they may not be watching advertisers claims closely enough, or warning patients about side effects strongly enough.
The Motley Fool July 29, 2010 Brian Orelli	Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.
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 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 31, 2011 Brian Orelli	Better Buy: Amarin or Clinical Data? A battle of the takeover targets.
The Motley Fool November 16, 2007 Brian Lawler	Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx.
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 June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
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 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 August 9, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
The Motley Fool May 26, 2009 Brian Orelli	When Higher Costs Are a Good Thing The Food and Drug Administration proposed its budget for the next fiscal year, including user fees for pharmaceutical companies. But GlaxoSmithKline, Merck, and the rest of the industry probably won't complain too loudly.
BusinessWeek May 21, 2007 John Carey	A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it?
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 March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
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.
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
Pharmaceutical Executive December 1, 2006 Jill Wechsler	Washington Report: The New Agenda Democrats are back on top in Congress after more than a decade as underdogs. The new leaders are mapping out a broad agenda with drug pricing and access high on the list.
Pharmaceutical Executive May 1, 2007 Jill Wechsler	Washington Report: Pathways for Proteins The push is on to establish an approval pathway for generic versions of biotech therapies. Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate.
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 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 October 9, 2008 Brian Orelli	When Science, Marketing, and Investing Collide How a pharmaceutical tries to sell more drugs can provide clues about its management.
The Motley Fool December 20, 2007 Brian Orelli	2007: The Year Pharma Fell in Love With Biologics The reason for pharma's newfound infatuation for biotech is quite clear. Many pharmaceutical companies are facing a patent cliff in the coming years, and they need to replace their blockbusters with something.
The Motley Fool June 11, 2009 Brian Orelli	The FTC Hates You, Too The agency weighs in (unhappily) on follow-on biologics.
The Motley Fool September 2, 2010 Brian Orelli	Fatter Wallet. Up 22%. Still Risky. After VIVUS' Qnexa was shot down at its FDA advisory panel, it's clear that Arena and Orexigen have an uphill battle in front of them.
The Motley Fool April 5, 2010 Brian Orelli	Up 30%? What Are You People On? Fast-track designations aren't worth much more than the paper they're printed on.
The Motley Fool May 3, 2010 Brian Orelli	While You Were Reveling in Dendreon's Win The FDA has approved Vimovo, an arthritis drug from Pozen and AstraZeneca, and Bristol-Myers Squibb also got a decision from the FDA, but it wasn't the positive kind.
The Motley Fool August 27, 2010 Brian Orelli	Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen.
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 April 8, 2004 Charly Travers	Indevus' Big Score (Maybe) A small biotech company lands a potentially rich deal.