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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 March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune.  |
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 February 3, 2009 Brian Orelli |
InterMune Batting .500 The results weren't exactly what Rule Breakers pick InterMune was looking for, but things could have been worse -- and the stock is up 38% today on the news.  |
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 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 June 18, 2009 Daniel Harrison |
Is Dendreon Just a Dot-Com Story at This Price? The stock has had a really good year, but now it may be time to lock in the gains.  |
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 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 June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.  |
The Motley Fool June 1, 2010 Brian Orelli |
Save Your Money, Dendreon As much as doctors would like to prescribe Dendreon's Provenge for their patients, manufacturing limitations will keep demand outpacing supply for awhile.  |
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 April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks.  |
The Motley Fool December 4, 2008 Brian Orelli |
Poor Pozen It's not often that you see a drug developer release data from two positive phase 3 trials for its lead pipeline compound and see its shares fall more than 4%, but that's what happened to Pozen.  |
The Motley Fool December 17, 2010 Brian Orelli |
An Overnight Double: Santa Visits InterMune in Europe The Committee for Medicinal Products for Human Use issued a positive recommendation for the approval of InterMune's idiopathic pulmonary fibrosis treatment, Esbriet, sending shares up 140%.  |
The Motley Fool January 17, 2007 Brian Lawler |
Dendreon in the Fast Lane The FDA speeds up review of Dendreon's leading drug candidate. Investors, take note.  |
The Motley Fool May 14, 2007 Brian Lawler |
Dendreon Tries to Pick Up the Pieces Dendreon lays out its preliminary plans following a negative FDA regulatory decision. Investors shouldn't necessarily take the smashed-down share price as indicative of a possible biotech value play.  |
The Motley Fool August 9, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.  |
The Motley Fool January 10, 2011 Brian Orelli |
By the Way, We Need to Run Another Trial InterMune has decided to run a new trial to gain U.S. approval on its idiopathic pulmonary fibrosis drug.  |
The Motley Fool March 11, 2010 Jim Mueller |
Is Medivation a Buy? What is the thinking with regards to Medivation today? It already got a big haircut last week. Is it worth investing in at these lower prices?  |
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 April 30, 2010 Brian Orelli |
Pricey Provenge Pumps Up Dendreon Dendreon's prostate cancer drug is approved, but at what cost, and will insurance pay for it?  |
The Motley Fool December 6, 2010 Brian Orelli |
3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise.  |
The Motley Fool May 10, 2006 Brian Lawler |
Dendreon Drives On Will the FDA say yes to a new cancer drug? Investors, take note.  |
The Motley Fool March 13, 2008 Brian Lawler |
Dendreon Rolls the Dice The pharmaceutical amends a phase 3 study on its lead prostate cancer drug.  |
The Motley Fool August 9, 2010 Brian Orelli |
Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble."  |
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 14, 2009 Brian Orelli |
Sell Dendreon! No, Buy Dendreon! Dendreon, everyone's favorite tiny biotech, just got bigger because of positive phase 3 results for its prostate cancer treatment, Provenge.  |
The Motley Fool November 10, 2006 Brian Lawler |
Dendreon Pending Approval A lot is riding on what the FDA will say about the small pharma's drug for prostate cancer. Investors, take note.  |
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 January 14, 2008 Brian Lawler |
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.  |
The Motley Fool December 26, 2006 Brian Lawler |
InterMune's Secret Drug Surprise Shares of InterMune have risen after positive trial results for one of its top drug candidates. Investors, take note.  |
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 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 19, 2009 Brian Orelli |
Dendreon Is No Dot-Com Story ... Yet Is Dendreon a bad buy at today's prices? Not if it gets cancer treatment Provenge approved. And there's the risk.  |
The Motley Fool December 31, 2007 Brian Lawler |
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.  |
The Motley Fool July 29, 2010 Brian Orelli |
Forget Respect -- Dendreon Needs Sales! Dendreon's Provenge was approved months ago, but the data from the clinical trial supporting the FDA's decision was finally published in the New England Journal of Medicine this week.  |
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 January 31, 2011 Brian Orelli |
5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list.  |
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 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 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 May 16, 2007 Brian Lawler |
GPC's Next Cancer Drug? GPC Biotech prepares for its future as it awaits an FDA decision on its lead drug. Investors, take note.  |
The Motley Fool January 7, 2011 Brian Orelli |
Dendreon Heads Across the Pond A pathway to Provenge approval in the EU.  |
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 3, 2006 S.J. Caplan |
AstraZeneca's Path to Avoid Pain The pharmaceutical giant partners with Pozen to co-develop a drug. Take heart, AstraZeneca shareholders! No queasy stomachs are expected in your future.  |
The Motley Fool October 8, 2007 Brian Orelli |
Pozen Submits Safety Data Will Pozen's response to its second approvable letter be enough? Investors may want to take this with a grain of salt.  |
The Motley Fool April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.  |
The Motley Fool April 26, 2007 Mike Havrilla |
Dendreon Is Worth a Shot Provenge might be approved, which means investors might be rewarded. However, the massive short interest also highlights the tremendous risk in Dendreon.  |
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.  |