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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 February 27, 2007 Brian Lawler |
FDA Keeps Novartis Waiting The pharmaceutical experiences a regulatory setback in the U.S. for one of its top drug candidates. Investors, take note.  |
The Motley Fool June 8, 2010 Brian Orelli |
Injecting Uncertainty Into the Multiple Sclerosis Market Novartis' oral MS drug could be a blockbuster -- if it can get past the FDA.  |
The Motley Fool November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain.  |
The Motley Fool January 31, 2007 Brian Lawler |
FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer.  |
The Motley Fool April 3, 2007 Brian Lawler |
Merck Gets the Combo Merck gets marketing approval for a diabetes combination drug. Investors, take note.  |
The Motley Fool June 11, 2010 Brian Orelli |
25 to 0! Now That's a Ringing Endorsement Novartis flies through its advisory panel meeting nearly unscathed.  |
The Motley Fool September 22, 2010 Jordan DiPietro |
A Huge Victory for Novartis MS oral drug is approved.  |
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 March 3, 2011 Brian Orelli |
3 Cheers for an FDA Rejection German drugmaker Merck said that the Food and Drug Administration had turned down its multiple sclerosis drug cladribine. The pill would have competed with Novartis' Gilenya, which gained FDA approval last year.  |
The Motley Fool April 25, 2007 Brian Lawler |
Nothing Wrong With Novartis Novartis releases first-quarter financial results. Investors, take note.  |
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 23, 2010 Brian Orelli |
A Blockbuster in Due Time Novartis' new multiple sclerosis drug, Gilenya, isn't king yet.  |
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 July 17, 2007 Brian Lawler |
Still Strong at Novartis For investors who are willing to filter the negative news and are patient enough to wait for recently launched branded compounds to help its top-line growth, Novartis is worth a look  |
The Motley Fool December 9, 2010 Brian Orelli |
Here Comes Another Oral MS Drug Good for Teva, bad for the rest.  |
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 April 7, 2011 Brian Orelli |
When Zombies Attack, Investors Win Novartis is hoping that Prexige has as much success coming back from the dead as Tysabri has.  |
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 22, 2008 Brian Lawler |
No Earnings Holes for Novartis The drugmaker holds its own in Q1; all three of its major divisions experienced sales growth, even in the face of some tough comparisons to last year.  |
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 November 14, 2007 Brian Lawler |
Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years.  |
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 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 October 11, 2010 Brian Orelli |
What Meridia's Demise Means for Arena, VIVUS, and Orexigen Safety first ... and second ... and third...  |
The Motley Fool November 16, 2007 Brian Lawler |
Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx.  |
The Motley Fool April 29, 2011 Brian Orelli |
Oral Multiple Sclerosis Drugs Heat Up Watch out Novartis and Gilenya.  |
The Motley Fool June 3, 2011 Luke Timmerman |
Orexigen, Facing High Hurdle at FDA, Puts Obesity Drug Development on Hold The close attention paid to safety makes this drug difficult to get right.  |
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 August 31, 2010 Brian Orelli |
Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior.  |
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 May 26, 2010 Brian Orelli |
Blockbuster Drugs Aimed at Busting MS Multiple sclerosis is a large market with more entrants coming.  |
The Motley Fool February 10, 2011 Brian Orelli |
Breathe Easier, Join the Competition Novartis' strategy is a good one.  |
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 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 April 17, 2007 Brian Lawler |
Merck Raises the Earnings Roof Shares of Merck soar after it raises 2007 earnings guidance.  |
The Motley Fool August 30, 2010 Brian Orelli |
It's a Blockbuster ... Maybe On the surface, sanofi-aventis' oral multiple sclerosis drug teriflunomide looks like a hit. But below the surface?  |
The Motley Fool April 13, 2011 Brian Orelli |
Drug Duo Escapes Advisory Panel Unharmed Pfizer and Novartis are on their way to expanding their cancer drug indications.  |
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 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 26, 2011 Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex?  |
The Motley Fool July 21, 2010 Brian Orelli |
Biogen Looks Good Now, but What About Tomorrow? Biogen Idec saw revenue increase 11% and adjusted earnings per share jump almost 75%, which is all well and good, but the longer-term prospects for the company aren't nearly as impressive.  |
The Motley Fool November 1, 2010 Brian Orelli |
Stock Doubles! No Crying Here AVANIR Pharmaceuticals' investors didn't have any uncontrolled crying on Friday when the Food and Drug Administration approved Nuedexta, the company's treatment for pseudobulbar affect.  |
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 12, 2011 Brian Orelli |
How Significant Is 'Statistically Significant' for Biogen? Biogen could have a third multiple sclerosis blockbuster on its hands.  |
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 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 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 December 24, 2009 Brian Orelli |
Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety.  |
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.  |