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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 October 17, 2007 Brian Orelli	FDA Warning Might Be a Buying Opportunity The 3%-4% drops in the stock prices of Amylin and Alkermes, Amylin's partner in the development of a sustained-release version of Byetta, could be a good buying opportunity for investors.
The Motley Fool January 26, 2010 Brian Orelli	Is Victoza's Victory in Vain? Novo Nordisk finally gets the FDA to sign off on its once-daily diabetes drug.
The Motley Fool October 20, 2010 Brian Orelli	There Are No Safe Biotech Investments Amylin Pharmaceuticals and its partners, Eli Lilly and Alkermes, announced yesterday evening that the Food and Drug Administration had asked for more data before approving its once-weekly diabetes drug Bydureon.
The Motley Fool August 25, 2009 Brian Orelli	How to Keep From Losing Your Shirt More side effects for weight-loss drugs -- maybe.
The Motley Fool July 15, 2010 Brian Orelli	The Blockbuster Drug Survives Another Body Blow Avandia is still standing.
The Motley Fool October 2, 2007 Brian Orelli	Amylin's Bittersweet FDA News Diabetes drug moves ahead, but not as much as the company wanted. If the FDA rejection was due to safety issues, that wouldn't bode well for Amylin's plans to develop the active ingredient in SYMLIN as a weight-loss drug. Investors, take note.
The Motley Fool March 5, 2008 Brian Orelli	FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs.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 August 27, 2008 Brian Orelli	Amylin Answers, Investors Panic Amylin Pharmaceuticals' conference call about side effects of its diabetes treatment, Byetta, doesn't have the desired effect.
The Motley Fool September 8, 2008 Brian Orelli	Another FDA Safety Warning (Yawn) The FDA warning results from numerous reports of fungal infections in patients taking TNF inhibitors.
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 November 27, 2007 Brian Orelli	Second Chance for Merck's MEVACOR Merck licenses the rights to an over-the-counter version of its cholesterol-lowering drug MEVACOR to GlaxoSmithKline, but the deal is far from done. Investors, take note.
The Motley Fool April 7, 2011 Brian Orelli	Restless No Longer XenoPort and Glaxo get a delayed FDA approval.
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 February 4, 2009 Brian Orelli	Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval.
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 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 April 13, 2009 Brian Orelli	Will These Drugs Get Past the FDA? Hopefully April won't bring showers of tears to these drugmakers: Eli Lilly... AstraZeneca... Bristol-Myers Squibb... Novo Nordisk... Johnson & Johnson...
The Motley Fool February 20, 2009 Brian Orelli	The Skinny on Diabetes Drugs The goal of diabetes drugs is to get the patient's blood glucose levels under control, but one class of drugs, called GLP1 agonists, have a nice side effect: weight loss. Which pharma companies can benefit?
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 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 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 November 3, 2009 Brian Orelli	Amylin Scores a Hat Trick Amylin Pharmaceuticals got a triple dose of good news over the weekend.
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 November 4, 2008 Brian Orelli	Does the Supreme Court Control Your Investment? The Supreme Court is about to make a decision that could affect drug company investors.
The Motley Fool September 16, 2010 Brian Orelli	Abbott's Product Line May Get Thinner Not that it needs the obesity drug.
The Motley Fool November 20, 2007 Brian Orelli	Explaining Onyx Pharmaceuticals' Sell-Off The FDA approved Nexavar as a treatment for liver cancer, but the good news causes a sell-off of the stock.
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 March 24, 2006 Brian Gorman	Cephalon Takes a Hit The FDA rules against its ADHD drug, but Cephalon's current lineup still holds promise. Investors may want to look at the current sell-off as a potential buying opportunity.
The Motley Fool June 9, 2008 Brian Orelli	Treading on a Johnson & Johnson Product Johnson & Johnson's Regranex, a drug for foot ulcers, gets a warning label.
The Motley Fool July 9, 2010 Brian Orelli	2 Days, 1 Blockbuster, Fate Unknown GlaxoSmithKline heads before a marathon two-day Food and Drug Administration advisory panel review of its diabetes drug Avandia.
The Motley Fool October 22, 2007 Brian Orelli	New Warnings Won't Sink ED Drug Sales Shockingly, new safety warnings won't hurt erectile dysfunction drugs. Any investor jumpiness should be looked at as a buying opportunity for smart investors.
The Motley Fool April 20, 2010 Brian Orelli	Drug Sales Down! Should We Celebrate? Amylin won't have completed results for a trial comparing Bydureon to Victoza until next year. But until that data is in, it might not be as easy to get the patients back as Amylin is making it out to be.
The Motley Fool June 23, 2010 Brian Orelli	Duo of Diabetes Drug Deals Make J&J Better Licensing deals add to Johnson & Johnson's diabetes franchise.
The Motley Fool January 15, 2010 Brian Orelli	Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all.
The Motley Fool September 28, 2009 Brian Orelli	Here We Go Again With Possible Side Effects The FDA says it has received 88 reports of pancreatitis in patients taking Merck's Januvia and Janumet.
The Motley Fool January 31, 2008 Brian Lawler	Prioritizing Millennium The FDA grants a speedy review for Millennium Pharmaceuticals's lead multiple myeloma drug.
The Motley Fool July 8, 2008 Brian Lawler	Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards.
The Motley Fool November 21, 2007 Brian Orelli	Phase 2 Data to Sink Your Teeth Into Novo Nordisk releases encouraging phase 2 clinical data about its weight-loss/diabetes drug, liraglutide. Investors, take note.
The Motley Fool November 27, 2009 Brian Orelli	A Mostly Meaningless FDA Approval After an accelerated approval, the positive effects of a full approval are minimal for Johnson & Johnson's drug, Intelence.
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 27, 2008 Brian Orelli	Another FDA Setback for Johnson & Johnson The company has to wait for an approval of its extended-release schizophrenia drug. Investors, take note.
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 July 11, 2008 Brian Orelli	Pfizer Looking at a Level Playing Field An advisory panel says that epilepsy drugs don't need a black-box warning, news that is positive for drug companies -- that is, those other than Pfizer.
The Motley Fool December 7, 2007 Brian Orelli	Amylin's Temporarily Worthless Label Expansion Amylin releases label expansion data that won't be useful for a few years. Investors, take note.
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 May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
The Motley Fool July 22, 2010 Brian Orelli	It's All About the Future for Amylin Its second quarter stank, but there's a lot up ahead.
The Motley Fool January 28, 2010 Brian Orelli	The Next Amgen? Not Yet. Amylin Pharmaceuticals is in much the same situation as Amgen is in: relatively flat sales, and the potential for a nice boost from a Food and Drug Administration approval shortly. But that's where the comparison ends.
The Motley Fool February 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.