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The Motley Fool July 13, 2009 Brian Orelli |
Finally! It's a Win, Isn't It? Eli Lilly and marketing partner Daiichi Sankyo finally got a Food and Drug Administration approval of their blood thinner, Effient (prasugrel), on Friday afternoon. |
The Motley Fool September 30, 2008 Brian Lawler |
No Approval for You ... Yet The FDA makes Eli Lilly wait for word on a lead drug. |
The Motley Fool January 5, 2010 Brian Orelli |
Lilly's Effient: Cheap Enough, for Now In order to justify the use of Effient, Eli Lilly is touting a study published in today's Circulation demonstrating the cost effectiveness of Effient over Plavix. |
The Motley Fool July 27, 2010 Brian Orelli |
Brilinta? I Think Not. AstraZeneca's new blood thinner is far from brilliant. |
The Motley Fool July 29, 2010 Brian Orelli |
This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either. |
The Motley Fool November 10, 2009 Brian Orelli |
3 Companies Looking for Gratitude Early These three small drug companies all have PDUFA dates in the next week: Cadence Pharmaceuticals... NeurogesX... Genzyme... |
The Motley Fool January 28, 2011 Brian Orelli |
Looking Ahead at Bristol-Myers Product approvals now will help with the upcoming patent cliff. |
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 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 July 23, 2010 Brian Orelli |
Eli Lilly Looks Great Today, but I'm Concerned About Tomorrow Eli Lilly is firing on all cylinders, but is there a blowout in its future? |
The Motley Fool December 1, 2008 Brian Orelli |
It's Wait Until Next Year for These Drugmakers Drugs from AstraZeneca and Eli Lilly face delays because of the FDA. Both plan to resubmit their applications for approval in the first half of next year, but the delays likely will have different effects on the companies. |
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 June 25, 2008 Brian Lawler |
Why the Lilly Delay, FDA? A government review of the company's top drug candidate gets pushed back. |
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 13, 2011 Brian Orelli |
FDA Panel Gives Eli Lilly Indigestion Eli Lilly's new acquisition causes a tummy ache. |
The Motley Fool December 30, 2008 Brian Orelli |
The FDA Needs a Bake Sale Money seems to be at the root of the problem with the FDA right now. It's pretty clear that fees, even though they're up to over $1 million per marketing application, aren't enough to get things done in a timely manner. |
The Motley Fool March 23, 2011 Brian Orelli |
Eli Lilly: Great Plan, Poor Execution Eli Lilly shuns large mergers, but hasn't produced drugs on its own. |
The Motley Fool June 2, 2010 Brian Orelli |
Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market. |
The Motley Fool December 31, 2008 Brian Orelli |
An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel. |
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 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 |
A Long-Term Play for Your Port Long-term prospects look better than the near term ones for Eli Lilly and its 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 December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
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 March 15, 2010 Brian Orelli |
Warning: Not All Boxed Warnings Are Equal Plavix's is mild in comparison. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
The Motley Fool June 25, 2010 Brian Orelli |
Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review. |
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 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 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 June 30, 2010 Brian Orelli |
When Researchers Attack, Investors Lose Drug investors have to watch out for a lot of things that can change their stock's price: earnings reports, clinical trial results, competitor's results, and FDA decisions. |
The Motley Fool May 26, 2009 Brian Orelli |
When Higher Costs Are a Good Thing The Food and Drug Administration proposed its budget for the next fiscal year, including user fees for pharmaceutical companies. But GlaxoSmithKline, Merck, and the rest of the industry probably won't complain too loudly. |
The Motley Fool August 20, 2010 Brian Orelli |
Depression Is Painful. Advisory Panels More So. Eli Lilly's Cymbalta has a rough time in from of the panel of experts. |
The Motley Fool September 9, 2010 Brian Orelli |
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. |
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 April 7, 2011 Brian Orelli |
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. |
The Motley Fool March 16, 2009 Brian Orelli |
Will the New FDA Chief Make Your Investments Healthy? President Obama's choice of Margaret Hamburg as head of the FDA seems to signify that the president is interested in the agency turning its focus toward protecting American's health. |
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 July 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
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 February 11, 2010 Brian Orelli |
A Turnaround Year, But Not in a Good Way 2009 was a solid year for sanofi-aventis thanks to a boost from sales of swine flu vaccine and some help from the exchange rate. But 2010? Not so solid. |
The Motley Fool April 30, 2010 Brian Orelli |
Living the Blockbuster Model AstraZeneca's top drugs provide top-line growth in the first quarter. |
The Motley Fool September 9, 2008 Brian Orelli |
Drug Duo Combines Its Way Toward an Approval Bristol-Myers and AstraZeneca are trying to get their diabetes drug approved as a combination treatment. |
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 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 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 December 15, 2006 Brian Lawler |
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. |
The Motley Fool September 20, 2010 Brian Orelli |
Potential Blockbuster, No Me-Too About It A diabetes-fighting duo do it right this time. |
The Motley Fool December 9, 2008 Brian Orelli |
The FDA Can't See the Forest or the Trees Forest Laboratories and Cypress Bioscience are still waiting for FDA approval, but now they've got more data to prove their point. |