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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 August 31, 2009 Brian Orelli |
Thinning Out Plavix's Monopoly Until now sanofi-aventis' and Bristol-Myers Squibb's Plavix didn't have a monopoly on the blood-thinning market, but it was pretty darn close. But now, another competitor's on the way. |
The Motley Fool May 11, 2009 Brian Orelli |
Brilliant, Now Let's See the Data AstraZeneca's investors today should be cautiously optimistic about Brilinta. It could be a blockbuster for the company, but it may need some brilliant marketing to compete. |
The Motley Fool October 30, 2009 Brian Orelli |
Of One-Time Gains and Pipelines AstraZeneca's earnings report illustrates the nature of polar opposites with one-time gains and new drugs. One is to be largely ignored, while the other will drive the drugmaker's future. |
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 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 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 March 19, 2009 Brian Orelli |
One Down, One to Go Sanofi-aventis slides past an FDA panel and hopes for more good news today |
The Motley Fool March 8, 2010 Brian Orelli |
Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting. |
The Motley Fool December 19, 2008 Brian Orelli |
Eli Lilly's Good News Misses the Mark EU approval of its blood thinner is nice, but U.S. approval is what will really matter. |
The Motley Fool November 16, 2009 Brian Orelli |
Music to Health-Care Investors' Ears Are faster FDA review times coming? |
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 November 21, 2008 Brian Orelli |
The Comeback of the Century? AstraZeneca is trying to revive Iressa. |
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 November 10, 2008 Brian Orelli |
Drug Fuels an Idling Rocket Ship AstraZeneca needs another FDA approval to really take advantage of its cholesterol drug's success. |
The Motley Fool June 11, 2010 Brian Orelli |
Pfizer and Bristol Coagulate Against Clots Let's see how apixaban does against warfarin before we break out the "blockbuster" stamp. |
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 January 28, 2011 Brian Orelli |
Looking Ahead at Bristol-Myers Product approvals now will help with the upcoming patent cliff. |
The Motley Fool March 15, 2010 Brian Orelli |
Warning: Not All Boxed Warnings Are Equal Plavix's is mild in comparison. |
The Motley Fool April 2, 2009 Brian Orelli |
A Diabetic Compromise Bristol-Myers and AstraZeneca will have to test their drug after it goes on the market. |
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 August 31, 2010 Brian Orelli |
A Mostly Meaningless FDA Rejection The Food and Drug Administration sends AstraZeneca back to the drawing board for the second time when it rejected motavizumab, the drugmaker's newest treatment for respiratory syncytial virus. |
The Motley Fool August 14, 2009 Brian Orelli |
Amgen Close to Scoring Big Amgen gets good-enough results from a FDA panel. |
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 August 31, 2009 Brian Orelli |
Good Luck, Genzyme -- You'll Need It The drugmaker faces an FDA advisory-panel showdown regarding its leukemia drug Clolar. |
The Motley Fool April 11, 2011 Brian Orelli |
A Double Dose of Trouble for Big Pharma? Pfizer's Sutent and Novartis's Afinitor head in front of an FDA advisory panel. |
The Motley Fool December 31, 2008 Brian Orelli |
An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel. |
The Motley Fool February 27, 2009 Brian Orelli |
Get a Life, Congress! A Congressional investigation into whether the FDA was right to pull a doctor off of the advisory panel for Eli Lilly's blood thinner prasugrel illustrates why Congress needs to keep its nose out of scientific discussions. |
The Motley Fool January 20, 2011 Brian Orelli |
Merck's Bleeding Out Vorapaxar caused it. |
The Motley Fool July 31, 2007 Brian Orelli |
GPC Takes a Pit Stop The biotech company pulls its New Drug Application for Satraplatin. There is something twisted about having to wait to get a drug to market because it's performing better than expected. Investors, take note. |
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 November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
The Motley Fool July 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
The Motley Fool November 18, 2009 Brian Orelli |
Your Heart or Your Stomach? It must be disappointing to know that a label change on another drug -- one that isn't even your competition -- is going to hurt sales, but that's the position that Procter & Gamble and AstraZeneca find themselves in. |
The Motley Fool October 23, 2009 Brian Orelli |
I Don't Need No Massive Merger Plavix's patent expiration is approaching, but Bristol-Myers Squibb is prepared. |
The Motley Fool June 11, 2009 Brian Orelli |
Kids, Take Your Antipsychotics! Drugs to combat mental illness might gain FDA approval for children. |
The Motley Fool May 29, 2009 Brian Orelli |
Delayed, Reason Unknown As long as Bayer and Johnson & Johnson can answer the FDA's questions relatively quickly, it shouldn't affect the companies too much. |
The Motley Fool March 18, 2009 Brian Orelli |
Johnson & Johnson and Shakespeare The stage is set for a dramatic decision. |
The Motley Fool January 29, 2009 Brian Orelli |
Lilly's in Need of a Pep Pill Eli Lilly's quarterly earnings report was pretty boring. Some drugs were up and others were down -- the end result was flat sales. |
The Motley Fool August 18, 2011 Brian Orelli |
Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works. |
The Motley Fool December 11, 2009 Brian Orelli |
Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no. |
The Motley Fool January 20, 2012 Brian Orelli |
19 Clinical Trials Aren't Enough The FDA rejects Bristol-Myers and AstraZeneca's dapagliflozin. |
The Motley Fool September 7, 2007 Brian Orelli |
Merck Says No to This Protein An FDA advisory panel recommends unanimous approval of a new HIV drug from Merck. The new class of HIV medications fight the virus by blocking one key protein from entering cells. |
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 April 4, 2011 Brian Orelli |
Anti-Infective, Very Effective The FDA seems to like Optimer's new antibiotic. |
The Motley Fool January 31, 2008 Brian Lawler |
A Zettlement for Zyprexa? Eli Lilly may be close to resolving a government lawsuit over improper marketing. |
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 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. |
Chemistry World July 31, 2007 Victoria Gill |
FDA Advised: Avandia Should Stay on the Market The US Food and Drug Administration's (FDA's) Advisory Committee came to an almost unanimous decision yesterday for Avandia, GlaxoSmithKline's much-maligned diabetes treatment, to remain on the US market. |
The Motley Fool June 3, 2011 Brian Orelli |
FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully. |