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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 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 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 April 17, 2008 Brian Orelli |
Headache Over for Pozen and Glaxo? The duo's FDA headache regarding their migraine drug is over, but a new one is about to begin.  |
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 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 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.  |
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 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 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 2, 2004 Roger Nusbaum |
POZEN Is a Poser Here's a great example of the riskiest type of biotech stock.  |
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 November 8, 2006 Brian Lawler |
Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient.  |
The Motley Fool June 21, 2007 Brian Lawler |
Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note.  |
The Motley Fool December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.  |
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 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 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 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 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.  |
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 May 30, 2008 Brian Orelli |
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil.  |
The Motley Fool April 25, 2011 Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it?  |
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 February 20, 2008 Brian Orelli |
Abbott's Copycat Combinations Abbott's latest FDA approval is for Simcor, a combination of Niaspan -- Abbott's slow-release niacin -- and the active component of Merck's Zocor, which isn't patent-protected anymore. Investors take note.  |
The Motley Fool February 22, 2011 Brian Orelli |
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.  |
The Motley Fool June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.  |
BusinessWeek August 26, 2010 Tom Randall |
Cocktails Are Next For Cancer-Drug Makers Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer.  |
The Motley Fool May 1, 2007 Mike Havrilla |
Heads Up, Biotech Investors Big news is in the offing for these companies. Pozen... Progenics... Zymogenetics... etc.  |
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, 2008 Brian Orelli |
FDA Moves Isis' Finish Line The FDA tells drugmaker Isis it must complete cancer tests before submitting its marketing application.  |
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.  |
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 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 24, 2011 Brian Orelli |
Youth in Revolt Against POZEN POZEN fails to get a pediatric extension on its migraine drug.  |
The Motley Fool May 18, 2009 Brian Orelli |
Is There Life After 600% Returns? Just because a drug company gets a massive increase in the stock price after a positive clinical trial or an FDA approval, that doesn't mean all the growth is completely factored into the stock price.  |
The Motley Fool July 12, 2010 Ryan McBride |
Synta Pharma CEO Trumpets New Top Cancer Drug Synta Pharmaceuticals has been climbing back from one of the Boston area's highest-profile clinical trial failures of 2009.  |
The Motley Fool December 3, 2010 Brian Orelli |
Obesity Drug Companies Are (Still) Risky Orexigen heads before an FDA panel.  |
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 May 21, 2010 Brian Orelli |
And You Thought Biotech Was High-Risk, High-Reward Large clinical trials make cardiovascular drugs risky, but the rewards are there, too.  |
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.  |
BusinessWeek June 12, 2006 Catherine Arnst |
Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming.  |
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 9, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.  |
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 December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.  |
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 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 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.  |