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The Motley Fool February 24, 2011 Brian D. Pacampara |
Salix Pharmaceuticals Shares Plunged: What You Need to Know Shares of Salix Pharmaceuticals plummeted more than 20% after the company said it expects the Food and Drug Administration to deny its bid to gain expanded approval for its gastrointestinal antibiotic Xifaxan. |
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 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 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 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 December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. |
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 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 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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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 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 9, 2008 Brian Orelli |
FDA Dashes Amylin Investors' Hopes Shareholders are still waiting to hear how much longer it'll be before Amylin and Eli Lilly can submit the marketing application for the once-weekly version of diabetes drug Byetta. |
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 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 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 July 18, 2007 Brian Lawler |
More Misery for Neurochem It's hard to find another drug developer that has mishandled its correspondence with investors about its drug candidates as badly as Neurochem has over the past year. |
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 May 10, 2011 Frank Vinluan |
Salix Sued by Partner for "Breach" Over HIV-Associated Drug Who will take this blockbuster drug to market? |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
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 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 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 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 December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
The Motley Fool October 20, 2011 Travis Hoium |
Amylin Pharmaceuticals Shares Jumped: What You Need to Know Shares of Amylin Pharmaceuticals jumped 11% today after the company released great earnings and pipeline news. |
The Motley Fool October 5, 2010 Brian Orelli |
You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure. |
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 March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool December 15, 2006 Brian Lawler |
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. |
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 June 14, 2010 Brian Orelli |
No Approval? No Problem! Investors shrug off Human Genome's news about its hepatitis C drug Zalbin. |
The Motley Fool August 12, 2008 Brian Lawler |
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
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 May 27, 2010 Brian Orelli |
This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do. |
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 June 30, 2004 Alyce Lomax |
A Monster Drug for Lilly? The drug giant files a new drug application (NDA) for its experimental new drug for diabetics. |
The Motley Fool February 25, 2008 Brian Lawler |
The Most Interesting FDA Review for 2008 Eli Lilly preps for an upcoming FDA review of its top pipeline drug, the blood thinner prasugrel. |
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 December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
The Motley Fool June 12, 2007 Brian Lawler |
Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg. |
The Motley Fool April 15, 2011 Luke Timmerman |
Amylin, Alkermes Shares Jump as EU Regulators Recommend Diabetes Drug Will this drug be approved in Europe? |
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 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 November 26, 2010 Brian Orelli |
Black Friday Biotech Bargains Drugmakers on sale. |
The Motley Fool May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
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 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 May 9, 2007 Brian Lawler |
Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note. |