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The Motley Fool August 9, 2011 Brian Orelli |
Some Potential Good News in Biotech The FDA should approve Gilead's Btripla. |
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 May 24, 2011 Brian Orelli |
J&J Approved, but Needs Help From a Friend The HIV combo product is the key. |
The Motley Fool October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
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 June 16, 2011 Brian Orelli |
Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from the FDA. |
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 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 27, 2009 Brian Orelli |
A Mostly Meaningless FDA Approval After an accelerated approval, the positive effects of a full approval are minimal for Johnson & Johnson's drug, Intelence. |
The Motley Fool January 4, 2012 Brian Orelli |
This Biotech's Obese To-Do List Is Done Arena resubmits lorcaserin for FDA approval. |
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 3, 2010 Brian Orelli |
Obesity Drug Companies Are (Still) Risky Orexigen heads before an FDA panel. |
The Motley Fool September 21, 2011 Brian Orelli |
Obesity-Drug Makers Stop Getting Bullied The drugs are still relative long shots being developed by companies that may have to raise more cash between now and an approval. |
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 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
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 1, 2011 Brian Orelli |
Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon. |
The Motley Fool January 9, 2012 Brian Orelli |
Don't Believe This Company's Warning VIVUS' news is great news. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
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 June 1, 2011 Brian Orelli |
Not All "Regulatory Updates" Are the Good Kind Orexigen gives an update; investors update their holdings. |
The Motley Fool June 28, 2011 Brian Orelli |
HIV Drug Partnership Gets a Boost Gilead and Johnson & Johnson hook up on a pair of new combo treatments. |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
The Motley Fool July 17, 2009 Brian Orelli |
Have a Cocktail Two virus killers are better than one. The latest two to hook up are Gilead Sciences and Johnson & Johnson. |
The Motley Fool April 5, 2011 Brian Orelli |
Obese Expectations Trump Great Data Sorry VIVUS and Orexigen, you're still not going to get your drugs approved quickly. |
The Motley Fool March 24, 2011 Brian Orelli |
It's the Combo That Matters for Gilead The same efficacy with fewer pills is the headline, but it's the understory that makes Gilead Sciences' latest clinical trial success important for investors. |
The Motley Fool October 25, 2010 Brian Orelli |
Arena's Boring News The Food and Drug Administration turned down Arena Pharmaceuticals' obesity drug, lorcaserin. Tell us something we didn't know. |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
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 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 November 23, 2009 Brian Orelli |
The Side Effect of Developing Obesity Drugs The FDA is fickle when it comes to weight-loss drugs. |
The Motley Fool December 31, 2011 Brian Orelli |
3 More Stock-Moving Binary Events to Watch in 2012 There are a lot of drugs that will face binary events in 2012 -- here are three to watch. |
The Motley Fool December 31, 2007 Brian Lawler |
Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners. |
The Motley Fool July 27, 2011 Brian Orelli |
Not Hypergrowth, but Good Enough Gilead posts a double-digit revenue gain. |
The Motley Fool September 19, 2008 Brian Lawler |
FDA Tells Gilead to Take 1 More Step There's a small consolation prize for Gilead Sciences in this rejection from the FDA. |
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 September 2, 2010 Luke Timmerman |
Orexigen Nabs $1B Deal With Takeda to Market Obesity Drug, Shares Climb San Diego-based Orexigen Therapeutics has found a partner to help it compete in the growing market for drugs to combat obesity, Japan-based Takeda Pharmaceutical. |
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 July 14, 2010 Luke Timmerman |
Vivus Faces Turning Point Tomorrow Thursday's the big day. All eyes will be on Vivus and the FDA's decision on their new obesity drug |
The Motley Fool January 6, 2010 Brian Orelli |
Gilead Goes It Alone ... for Now Investors jump for joy as Gilead Sciences announces what on the surface sounds like rather inconsequential data. |
The Motley Fool June 27, 2011 Brian Orelli |
Data Galore, but Where's the FDA Approval? Presentations at the American Diabetes Association won't help with approvals. |
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. |
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 September 17, 2010 Brian Orelli |
Thanks for Nothing, Fen-Phen Arena gets knocked down despite a relatively clean side-effect profile. |
The Motley Fool July 21, 2006 Brian Lawler |
Gilead's Acquisitive Mood Trading at around 28 times 2006 EPS estimates, and with 40% growth expected for its HIV franchise, Gilead offers tempting value -- assuming it makes smart use of that cash sitting on the balance sheet. |
The Motley Fool December 22, 2010 Brian Orelli |
Arena Charges On It seems Fool readers were a little more optimistic about the timing of Arena Pharmaceuticals' resubmission of its obesity drug to the Food and Drug Administration than the company is. |
The Motley Fool March 16, 2010 Brian Orelli |
How to Lose $114 Million in One Day You've got to be a very trusting investor to buy shares in pharmaceutical company, MannKind. |
The Motley Fool June 3, 2009 Brian Orelli |
No More Triple-Digit Returns? If FDA decisions could be predicted easily, investors might not get to enjoy triple-digit returns, so perhaps we shouldn't be too upset about the tight-lipped nature of the FDA. |
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 December 11, 2009 Brian Orelli |
Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no. |