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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. mark for My Articles similar articles
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. 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
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
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
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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
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
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. 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
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
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
June 18, 2010
Brian Orelli
Hot Dog! No Competition for Now Roche's diabetes pipeline drug is delayed. 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
November 26, 2010
Brian Orelli
Black Friday Biotech Bargains Drugmakers on sale. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 15, 2011
Brian Orelli
BioSante Shares Crushed by Placebo Effect BioSante's LibiGel efficacy is not deemed statistically significant. 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
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
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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
November 8, 2011
David Williamson
Biotech Pops, Drops, and Break-Ups Highlighting the day's health-care stories critical to investors. mark for My Articles similar articles
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. 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
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
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. 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
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
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 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 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. mark for My Articles similar articles
The Motley Fool
February 25, 2011
Brian Orelli
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections? 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
July 8, 2011
Luke Timmerman
Amylin, Alkermes Once-Weekly Diabetes Drug Passes Heart Trial What does this mean for the drug companies? mark for My Articles similar articles
The Motley Fool
December 15, 2011
David Williamson
1 Massive Biotech Bloodbath Trial results and FDA panels ruled the health-care sector today. 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
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
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
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. mark for My Articles similar articles
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. mark for My Articles similar articles