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The Motley Fool March 3, 2009 Brian Orelli	A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals.
The Motley Fool January 26, 2009 Brian Orelli	Which One of These Is Not Like the Other? Bristol-Myers and Eli Lilly run into some comparability issues.
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 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.
The Motley Fool December 12, 2008 Brian Orelli	Amylin Gets Some FDA Love Amylin's once-weekly diabetes drug Byetta gets a green light from the FDA.
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 March 15, 2010 Brian Orelli	FDA Says "No Way!" Market Says "Yeah, Baby!" You can have it both ways. The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals, Eli Lilly, and Alkermes were looking for, but they'll take it.
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 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 March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
The Motley Fool November 5, 2008 Brian Orelli	A Byetta Beating The FDA gives Amylin and Alkermes a smack down, but neither company is knocked out yet.
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 March 30, 2010 Brian Orelli	Invest in This Space at Your Own Risk Lung cancer is a tough foe for drugmakers.
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 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 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.
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 December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool November 1, 2007 Brian Orelli	Good News From Amylin Isn't Good Enough Investors aren't impressed by Amylin's extended-release version of Byetta, worrying that the drug may be reaching market saturation.
The Motley Fool November 18, 2008 Brian Orelli	Genzyme Grounded for Thanksgiving The biotech won't get a decision on Myozyme until February.
The Motley Fool June 26, 2009 Brian Orelli	Looking for a Sliver of the Me-Too Pie Another diabetes drug is close to hitting the market.
The Motley Fool September 13, 2007 Brian Orelli	Alfacell's Awkward Wait Waiting for subjects to die is a somber part of the oncology clinical trial process. Alfacell is doing just that in its final phase three trial with its lead cancer drug candidate. Investors take note.
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 April 8, 2009 Brian Orelli	I'm Rich! I'm Ruined! Overreaction Equals Opportunity Knowing your company lets you judge when the market has overreacted.
The Motley Fool November 10, 2009 Brian Orelli	3 Companies Looking for Gratitude Early These three small drug companies all have PDUFA dates in the next week: Cadence Pharmaceuticals... NeurogesX... Genzyme...
The Motley Fool March 27, 2009 Brian Orelli	The Skinny on a Triple-Decker Update Amylin's public relations department might need to go on a diet.
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 29, 2009 Brian Orelli	Ignore These Companies at Your Peril You may not want to invest in them, but don't ignore them.
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 April 15, 2011 Brian Orelli	Fewer Needle Pricks for the Europeans Amylin's once-weekly diabetes drug Bydureon gets a positive recommendation in Europe.
The Motley Fool May 9, 2007 Brian Lawler	Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note.
The Motley Fool January 27, 2011 Brian Orelli	Amylin Timeline Shortened -- Maybe Revenue down 6% year over year. Prescriptions of the company's top-selling drug, Byetta, down 5.9% quarter over quarter. Amylin Pharmaceuticals' fourth quarter wasn't pretty.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
The Motley Fool November 26, 2010 Brian Orelli	Black Friday Biotech Bargains Drugmakers on sale.
The Motley Fool February 10, 2009 Brian Orelli	Roses and Candy From the FDA? Some drugmakers expect the FDA to bestow its kiss of approval this month. Read on to see who.
The Motley Fool May 22, 2007 Mike Havrilla	Savient Seems Set for a Success With generic competition against one drug, the company is ready to produce another. Biotech investors are encouraged to take a look here.
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 January 20, 2011 Brian Orelli	This Stock Is No Dreamboat The FDA is not kind to MannKind.
The Motley Fool July 8, 2011 Brian Orelli	Let's Just Hope For No More FDA Surprises Despite the government's worries, Bydureon doesn't cause heart issues.
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 October 18, 2007 Brian Orelli	Amylin: Waiting on the Future Research and development costs drag down the drug developer's bottom line. Investors, take note.
The Motley Fool May 18, 2009 Brian Orelli	Is There Life After 600% Returns? Just because a drug company gets a massive increase in the stock price after a positive clinical trial or an FDA approval, that doesn't mean all the growth is completely factored into the stock price.
The Motley Fool March 5, 2008 Brian Orelli	FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs.
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 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 June 17, 2009 Brian Orelli	Savient Saves and Moves Up The FDA advisory panel gives Savient's Krystexxa a passing grade.
The Motley Fool May 3, 2007 Mike Havrilla	Heads Up, Biotech Investors: Chapter 3 Time your stocks, not the market. Savient... VISICU... VIVUS... Cortex...
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 December 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.