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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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 28, 2010
Brian Orelli
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
December 8, 2010
Brian Orelli
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 2, 2010
Brian Orelli
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
October 5, 2010
Brian Orelli
You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
March 10, 2010
Brian Orelli
Up 160% With Room to Run You've got to love biotech and InterMune. mark for My Articles similar articles
The Motley Fool
December 15, 2006
Brian Lawler
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
February 26, 2011
Brian Orelli
FDA Applications and a Look Ahead It isn't pretty. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 22, 2003
Alyce Lomax
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 26, 2010
Brian Orelli
Black Friday Biotech Bargains Drugmakers on sale. mark for My Articles similar articles
The Motley Fool
May 31, 2011
Brian Orelli
Pay Attention, Biotech Investors Competitors and partners can't be ignored. mark for My Articles similar articles
The Motley Fool
September 29, 2011
Brian Orelli
Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles