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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 December 31, 2011 Brian Orelli |
3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.  |
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 November 26, 2010 Brian Orelli |
Black Friday Biotech Bargains Drugmakers on sale.  |
The Motley Fool December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson.  |
The Motley Fool March 3, 2009 Brian Orelli |
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals.  |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty.  |
The Motley Fool April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval.  |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod.  |
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 October 5, 2011 Brian Orelli |
1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response.  |
The Motley Fool August 18, 2011 Brian Orelli |
Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.  |
The Motley Fool September 8, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.  |
The Motley Fool April 21, 2011 Brian Orelli |
Who's Next? 5 Potential Biotech Takeover Targets Exelixis has reportedly hired Goldman Sachs to shop the development-stage drugmaker around to the highest bidder. With an asset like XL184, there should be someone interested.  |
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 December 31, 2008 Brian Orelli |
An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel.  |
The Motley Fool March 15, 2010 Brian Orelli |
FDA Says "No Way!" Market Says "Yeah, Baby!" You can have it both ways. The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals, Eli Lilly, and Alkermes were looking for, but they'll take it.  |
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 December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.  |
The Motley Fool February 10, 2009 Brian Orelli |
Roses and Candy From the FDA? Some drugmakers expect the FDA to bestow its kiss of approval this month. Read on to see who.  |
The Motley Fool February 25, 2011 Brian Orelli |
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections?  |
The Motley Fool October 9, 2006 Brian Lawler |
The Commandments of Biotech Investing, Part 2 It's a complex field, but it's not impossible for investors to master. The more in-depth your research of a potential biotech investment, and the more you remember to follow these commandments, the better your potential for success will be when investing in this fascinating field.  |
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 December 14, 2010 Brian Orelli |
3 Ways to Play Biotech With Options Are you looking for a way for options to help you decrease the risk of investing in biotechnology? Then read on.  |
The Motley Fool December 12, 2008 Brian Orelli |
Amylin Gets Some FDA Love Amylin's once-weekly diabetes drug Byetta gets a green light from the FDA.  |
The Motley Fool April 8, 2011 Brian Orelli |
A Shutdown of Binary Events? A government shutdown will likely stop FDA approvals.  |
The Motley Fool February 4, 2009 Brian Orelli |
Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval.  |
The Motley Fool November 8, 2007 Charly Travers |
BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent.  |
The Motley Fool October 5, 2010 Brian Orelli |
You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure.  |
The Motley Fool July 27, 2010 Jim Mueller |
3 Stocks to Play Biotech Here are three promising ideas for this exciting area.  |
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 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 February 1, 2011 Brian Orelli |
Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.  |
The Motley Fool October 2, 2007 Brian Orelli |
Amylin's Bittersweet FDA News Diabetes drug moves ahead, but not as much as the company wanted. If the FDA rejection was due to safety issues, that wouldn't bode well for Amylin's plans to develop the active ingredient in SYMLIN as a weight-loss drug. Investors, take note.  |
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 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 August 3, 2009 Brian Orelli |
The Roller-Coaster Stock That Keeps on Giving Savient's gout treatment isn't approved just yet.  |
The Motley Fool December 6, 2010 Brian Orelli |
3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise.  |
The Motley Fool April 8, 2009 Brian Orelli |
I'm Rich! I'm Ruined! Overreaction Equals Opportunity Knowing your company lets you judge when the market has overreacted.  |
The Motley Fool February 11, 2011 Brian Orelli |
Biotech Optimists Throw In the Towel As the chance of survival improves, the stock falls. Wait, what?  |
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 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 December 22, 2009 Brian Orelli |
2009 Biotech Cheers and Jeers Lessons from biotech's 2009 surprises. Will 2010 be just as exciting? Considering that it's biotech, I'd have to say "yes."  |
The Motley Fool March 30, 2010 Brian Orelli |
FDA Lags, Investors Flee Cephalon gets no love from the FDA. The agency failed to expand Cephalon's Nuvigil for the treatment of jet lag.  |
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 9, 2008 Brian Orelli |
The FDA Can't See the Forest or the Trees Forest Laboratories and Cypress Bioscience are still waiting for FDA approval, but now they've got more data to prove their point.  |
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 June 26, 2009 Brian Orelli |
Looking for a Sliver of the Me-Too Pie Another diabetes drug is close to hitting the market.  |
The Motley Fool March 13, 2009 Brian Orelli |
Will These Drugs Get Past the FDA? Let's take a look at which pharma companies are hoping to score with the FDA this month.  |
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.  |