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The Motley Fool July 27, 2010 Brian Orelli |
Brilinta? I Think Not. AstraZeneca's new blood thinner is far from brilliant. |
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 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 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 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 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 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 March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note. |
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 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
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 December 31, 2008 Brian Orelli |
An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel. |
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 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 31, 2007 Brian Lawler |
Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price. |
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 October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
The Motley Fool November 29, 2007 Brian Lawler |
Another Chapter in Glaxo's Relenza Saga An FDA advisory panel suggested that the Relenza label should be strengthened to include the possibility of abnormal behavior and hallucinations in those who take it. |
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 July 13, 2011 Brian Orelli |
2 Questions for Seattle Genetics So far the FDA is fairly impressed with Seattle Genetics' lymphompa drug brentuximab vedotin. |
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 March 18, 2009 Brian Orelli |
Johnson & Johnson and Shakespeare The stage is set for a dramatic decision. |
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 December 14, 2007 Brian Lawler |
Ignore the Dendreon Hoopla A Congressional probe request will have no effect on Dendreon or Provenge's odds at making it through the FDA, since it was not the FDA reviewers of the Provenge marketing application that were accused of anything bad. |
The Motley Fool September 10, 2008 Brian Lawler |
A Pfizer Drug With a Cloudy Future The company offers another drug with mixed odds to the FDA. |
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 May 3, 2010 Brian Orelli |
While You Were Reveling in Dendreon's Win The FDA has approved Vimovo, an arthritis drug from Pozen and AstraZeneca, and Bristol-Myers Squibb also got a decision from the FDA, but it wasn't the positive kind. |
The Motley Fool March 31, 2009 Brian Orelli |
Destiny for Diabetes Drugs The Food and Drug Administration has a two-day advisory panel lined up so that panelists can give their opinions on a pair of diabetic drugs. |
The Motley Fool November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
The Motley Fool March 28, 2011 Brian Orelli |
Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news. |
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 December 6, 2007 Brian Lawler |
Genentech Voted Down An FDA panel recommends against expanded use of Genentech's lead drug. |
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 August 21, 2008 Brian Orelli |
Johnson & Johnson Gets Rejected The FDA rejects Johnson & Johnson's bid to expand the label of its antibiotic. |
The Motley Fool May 20, 2011 Brian Orelli |
Abbott Hits a Triple Not a home run, but Trilipix will likely stay on the market. |
The Motley Fool February 1, 2011 Brian Orelli |
Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon. |
The Motley Fool June 20, 2011 Brian Orelli |
See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely. |
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 May 13, 2011 Brian Orelli |
FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved. |
The Motley Fool November 16, 2009 Brian Orelli |
Music to Health-Care Investors' Ears Are faster FDA review times coming? |
The Motley Fool April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. |
The Motley Fool July 23, 2007 Brian Lawler |
GPC's Date With the FDA A document released by the FDA outlines its concerns with GPC's lead drug. Investors, take note. |
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 3, 2007 Brian Lawler |
Dendreon's Positive Panel Surprise Shares of the drugmaker jump after a FDA advisory panel finds in favor of its lead cancer compound. |
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 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 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 July 8, 2008 Brian Lawler |
Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards. |