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The Motley Fool February 14, 2011 Brian Orelli |
This Biotech Is Heating Up Biosante Pharmaceuticals was up more than 9% at one point today after the company said the independent Data Monitoring Committee believed Biosante's female sexual dysfunction drug, LibiGel, was safe enough to allow the trial to continue. |
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 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 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 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 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 3, 2011 Brian Orelli |
Amylin Comes Up Snake Eyes Amylin Pharmaceuticals and partners Eli Lilly and Alkermes announced results of their head-to-head clinical trial comparing Bydureon with Novo Nordisk's diabetes drug Victoza. |
The Motley Fool December 14, 2011 David Williamson |
BioSante Investors: It Was Nice While It Lasted Libigel loses to placebo in two studies, shares down 75% after hours. |
The Motley Fool March 3, 2011 Brian D. Pacampara |
Amylin Pharmaceuticals Shares Plunged: What You Need to Know Shares of Amylin Pharmaceuticals plummeted more than 20% Thursday after its type 2 diabetes drug Bydureon failed to meet primary endpoints in a 26-week study. |
The Motley Fool July 13, 2011 Brian Orelli |
BioSante Is Ready for Some Action Investors are opening positions in BioSante in anticipation of the release of company data from two clinical trials for its female sexual-dysfunction treatment, LibiGel, by the end of the year. |
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 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, 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 December 27, 2011 Brian Orelli |
Exelixis 2011: Not What the Doctor Ordered A tale of an inability to get a Special Protocol Assessment from the FDA. |
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 December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. |
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 June 18, 2010 Brian Orelli |
Hot Dog! No Competition for Now Roche's diabetes pipeline drug is delayed. |
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 November 26, 2010 Brian Orelli |
Black Friday Biotech Bargains Drugmakers on sale. |
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 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 December 15, 2011 Brian Orelli |
BioSante Shares Crushed by Placebo Effect BioSante's LibiGel efficacy is not deemed statistically significant. |
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 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 October 24, 2011 Brian Orelli |
Biotech Blunder Turned 20% Overnight Gain Exelixis gets good data, even if it wasn't exactly what it was expecting. |
The Motley Fool June 18, 2007 Brian Lawler |
The Third Time Isn't the Charm for Encysive The approvable letter for the pulmonary arterial hypertension treatment marks the third time Thelin has failed to get full approval from the FDA. Investors, take note. |
The Motley Fool January 29, 2008 Brian Lawler |
BioSante's Gamble Against Generics BioSante releases more information on the pivotal studies for its lead drug. |
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 November 8, 2011 David Williamson |
Biotech Pops, Drops, and Break-Ups Highlighting the day's health-care stories critical to investors. |
The Motley Fool April 17, 2009 Brian Orelli |
Cost-Cutting? Check. Increased Sales? Hmm ... Amylin has half the equation. Now it needs the other half. |
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 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 June 16, 2010 Brian Orelli |
A Drop on Bad News, but It Was a Long Shot Anyway Bydureon, Amylin Pharmaceuticals and Eli Lilly's once-weekly version of their twice-daily Byetta, has been beating up other diabetes drugs in a series of head-to-head clinical trials but it will have a tough time going after the monotherapy 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 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 November 9, 2011 Brian Orelli |
Byetta Breakup! Buying Opportunity? We all saw this coming. Amylin Pharmaceuticals and Eli Lilly decided staying together for the kids just wasn't worth it |
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 11, 2008 Brian Orelli |
Amylin's Down and Up on Diabetes Investors may be over-reacting to news both good and bad from Amylin Pharmaceuticals. |
The Motley Fool February 25, 2011 Brian Orelli |
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections? |
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 July 8, 2011 Luke Timmerman |
Amylin, Alkermes Once-Weekly Diabetes Drug Passes Heart Trial What does this mean for the drug companies? |
The Motley Fool December 15, 2011 David Williamson |
1 Massive Biotech Bloodbath Trial results and FDA panels ruled the health-care sector today. |
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 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 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 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 September 6, 2007 Brian Lawler |
Encysive, Please Stop Its failure to acquiesce to the FDA's request means the competition is going forward as this drugmaker's product stays stagnant. Investors, take note. |