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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 January 16, 2008 Brian Orelli |
Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know.  |
The Motley Fool August 3, 2007 Brian Orelli |
Another Headache for Pozen Investors Drugmaker Pozen might have to run one more trial for the FDA for its migraine drug.  |
The Motley Fool December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.  |
The Motley Fool February 24, 2011 Brian Orelli |
Youth in Revolt Against POZEN POZEN fails to get a pediatric extension on its migraine drug.  |
The Motley Fool April 7, 2011 Brian Orelli |
Restless No Longer XenoPort and Glaxo get a delayed FDA approval.  |
The Motley Fool August 3, 2007 Brian Lawler |
Flamel Cooked When a drugmaker's future is highly dependent on one product, shares are bound to take a hit if that product isn't living up to expectations. Such was the case with Flamel Technologies.  |
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 November 26, 2011 Stephanie Baum |
Pozen Inks $75 Million Royalty Deal for Treximet The pharma sells U.S. rights for the migraine drug to Canada's national pension fund.  |
The Motley Fool October 16, 2007 Brian Orelli |
Pozen Hedges Its Bets As promised, Pozen and partner GlaxoSmithKline announce that the pair have submitted a response to their approvable letter for Trexima, and that they plan to do an additional just-in-case safety trial.  |
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 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.  |
BusinessWeek February 27, 2006 Gene G. Marcial |
Pozen's Trexima: Going To Market With Glaxo Pozen's Trexima is a new drug for severe headaches that analysts claim is more effective and faster-acting than GlaxoSmithKline's $1 billion-a-year blockbuster Imitrex.  |
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 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.  |
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 May 17, 2007 Mike Havrilla |
Pozen Poised for Profits The pharmaceutical reported first-quarter results. But investors should look to buy shares of this company because of how its results may look later this year.  |
The Motley Fool April 10, 2008 Brian Lawler |
Glaxo Angers the FDA GlaxoSmithKline announces that the FDA has sent it a warning letter regarding its failure to meet certain post-marketing requirements for Avandia.  |
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 April 16, 2011 |
Pozen Wins Injunction Blocking Generic Migraine Drug The ruling against Par Pharmaceutical comes just in time for Pozen.  |
Pharmaceutical Executive April 1, 2011 |
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.  |
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 November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.  |
The Motley Fool March 31, 2011 Brian Orelli |
Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good.  |
Chemistry World September 24, 2010 Andrew Turley |
End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use.  |
The Motley Fool April 26, 2011 Brian Orelli |
We Hate Your Drug. And That's a Good Thing. This one's a pain for the clinical trial participants.  |
The Motley Fool July 27, 2010 Brian Orelli |
Brilinta? I Think Not. AstraZeneca's new blood thinner is far from brilliant.  |
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 September 17, 2010 Luke Timmerman |
Cell Therapeutics OK'd to Sell Shares to Stay Alive Is the company being straight with shareholders?  |
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 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 February 18, 2010 Brian Orelli |
Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance.  |
The Motley Fool February 11, 2008 Brian Lawler |
No Fire Fueling Flamel's Top Drug Flamel Technologies had a rough 2007; and with only one drug determining its near-term success, investors should be cautious of this drugmaker.  |
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 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 March 21, 2011 Brian Orelli |
Let's See Some Data, Curis Curis investors seem to have shrugged off the multiple unknowns and embraced the potential for the company's skin cancer drug.  |
The Motley Fool March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.  |
The Motley Fool September 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug.  |
The Motley Fool September 21, 2010 Brian Orelli |
Double-Digit Weight Loss, Double-Digit Share Increase Vivus is down, but apparently not out.  |
The Motley Fool July 13, 2010 Brian Orelli |
A Triple Delight: 3 Stocks All Up More Than 10% What's good for the obese goose is good for the gander when it comes to new drug treatments for losing weight.  |
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 December 3, 2007 Brian Orelli |
Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol.  |
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 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 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 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 17, 2007 Andrew R. Vaino |
Problems Posed for Pozen If its latest drug isn't approved, the pharmaceutical's stock will clearly tank. Any benefits stemming from the drug's successful approval are harder to gauge.  |
The Motley Fool January 25, 2010 Brian Orelli |
No Way to Hide This Drug Approval FDA trumps Acorda on its good news. The biotech announced Food and Drug Administration approval of Ampyra, its drug to help multiple sclerosis patients walk better after the markets closed on Friday.  |
The Motley Fool June 18, 2010 Brian Orelli |
Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday.  |
The Motley Fool April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval.  |