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The Motley Fool July 25, 2007 Brian Lawler |
GPC Must Wait An advisory panel recommends against approving GPC's lead drug right now. Investors, take note. |
The Motley Fool November 1, 2007 Brian Lawler |
Achtung, GPC! The German biotech sector took a hit yesterday, after GPC Biotech and partner Pharmion announced that GPC's lead drug, satraplatin, had failed an important endpoint in phase 3 testing. |
The Motley Fool August 10, 2007 Brian Lawler |
GPC Picking Up the Pieces GPC Biotech announced second-quarter financial results last week, in the shadow of a setback; they are awaiting more data on a crucial drug candidate. |
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 June 20, 2007 Brian Lawler |
GPC Markets Itself GPC showcases itself at two investor conferences last week. The biotech's shares have nearly doubled off of its 52-week lows, following the announcement of successful phase 3 results and anticipation of FDA approval for its lead compound. |
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 31, 2008 Brian Lawler |
GPC Recaps a Tough Year Development-stage drugmaker GPC Biotech releases its year-end financial results after a 2007 in which the FDA depth-charged its lead drug. |
The Motley Fool December 4, 2007 Brian Lawler |
Will Avastin Squeeze Past the FDA? Unless an FDA advisory panel provides extremely strong reasoning for approving Avastin on the evidence of PFS benefits alone, Genentech and its investors should expect another approvable letter come January. |
The Motley Fool October 29, 2007 Brian Lawler |
World's Scariest Stock: Dendreon Investing in the biotech sector is scary enough for most investors. Dendreon's scary future should makes this stock an under-performer. |
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 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 December 6, 2007 Brian Lawler |
Genentech Voted Down An FDA panel recommends against expanded use of Genentech's lead drug. |
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 September 26, 2006 Brian Lawler |
GPC's Trial Glee A new platinum-based cancer treatment yields encouraging results. 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 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 August 8, 2007 Brian Lawler |
Dendreon Plods Along The turbulent drug developer releases its second-quarter financial results. Investors, take note. |
The Motley Fool November 9, 2007 Brian Lawler |
GPC Regroups Pharma GPC Biotech updates investors following a surprising setback on its lead drug. Investors, take note. |
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 December 10, 2007 Brian Lawler |
Will the FDA Clear Cardiome? The agency prepares to debate Cardiome's lead drug candidate, Vernakalant, a treatment for abnormal heart rhythms. 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 March 17, 2008 Brian Lawler |
The Panelling on Amgen's Walls One FDA panel ruling is a win, another is much less upsetting than investors feared. |
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 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 June 27, 2007 Brian Lawler |
Waiting on GPC Exciting development-stage drugmaker GPC's marketing partner files a European marketing application for its top drug. |
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 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. |
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 November 16, 2010 Luke Timmerman |
Dendreon Prepares to Take Some Heat Over Cancer Drug Prices Dendreon looking for off-label uses for its prostate cancer drug. |
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 July 16, 2009 Brian Orelli |
Keep Your Chin Up, J&J An FDA advisory committee smacked down its drug candidate. |
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 March 4, 2010 Brian Orelli |
Best in Class ... For Now Sanofi's new prostate cancer drug is better than nothing. |
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 November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
The Motley Fool August 1, 2007 Brian Lawler |
Elan Gets a Vote of Confidence Elan receives some good news from an FDA advisory panel in the form of a recommendation to expand the use of Tysabri to treat Crohn's disease. |
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 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 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 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 September 13, 2007 Brian Lawler |
Don't Bet on the Dendreon Lawsuit A patient advocacy group files a lawsuit attempting to usher Dendreon's prostate cancer drug Provenge onto the market after the FDA has withheld approval. Investors should take note. |
The Motley Fool September 14, 2010 Luke Timmerman |
Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug. |
The Motley Fool June 5, 2007 Brian Lawler |
Dendreon Gets Its Funding Dendreon does a financing to secure its near-term future. Investors who fail to pay attention to relative valuations of the different stocks in the development-stage biotech space do so at their own peril. |
The Motley Fool September 13, 2007 Brian Orelli |
Alfacell's Awkward Wait Waiting for subjects to die is a somber part of the oncology clinical trial process. Alfacell is doing just that in its final phase three trial with its lead cancer drug candidate. Investors take note. |
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 January 22, 2008 Brian Lawler |
Adolor Under the FDA's Spotlight The FDA releases its documents on Adolor's lead drug, with surprising good news in advance of an advisory panel discussion. Investors, take note. |
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 6, 2011 Brian Orelli |
Pfizer Faces Firing Line A panel of outside experts will help decide Inlyta's fate. |
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 20, 2011 Brian Orelli |
See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely. |