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The Motley Fool December 10, 2008 Brian Orelli |
A Painless Advisory Panel Meeting Genzyme might be getting a Christmas present from the Food and Drug Administration. An FDA advisory panel unanimously recommended approval for Genzyme's osteoarthritis pain drug Synvisc-One.  |
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 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 December 11, 2008 Brian Orelli |
A Painful Letter from the FDA The FDA smacked down King Pharmaceuticals and Pain Therapeutics with a complete response letter for their application to market Remoxy, an abuse-resistant controlled-release form of oxycodone.  |
The Motley Fool August 14, 2008 Brian Lawler |
A Potentially Painless PDUFA Date King Pharmaceuticals and Pain Therapeutics get an appointment with the FDA.  |
The Motley Fool April 29, 2008 Brian Orelli |
Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month.  |
The Motley Fool October 19, 2010 Brian Orelli |
When the Status Quo Is a Big Win The lack of an FDA rejection will do just fine. Amgen and Johnson & Johnson seemed to get through the FDA advisory panel process without much problem yesterday.  |
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 April 13, 2009 Brian Orelli |
Will These Drugs Get Past the FDA? Hopefully April won't bring showers of tears to these drugmakers: Eli Lilly... AstraZeneca... Bristol-Myers Squibb... Novo Nordisk... Johnson & Johnson...  |
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 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 May 5, 2008 Brian Lawler |
Good News for Abuse-Resistant Drugs Drug developers working on harder-to-abuse pain remedies, including Pain Therapeutics, King Pharmaceuticals, and Alpharma, got a guarded thumbs-up from the FDA last week.  |
The Motley Fool November 14, 2008 Brian Orelli |
Gravy or Turkey From the FDA? Johnson & Johnson, Genzyme, and AstraZeneca should be made aware of their FDA fate over the next few weeks.  |
The Motley Fool August 29, 2011 Brian Orelli |
A Less Painful FDA Decision Johnson & Johnson gains approval of Nucynta ER.  |
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 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 June 17, 2009 Brian Orelli |
Savient Saves and Moves Up The FDA advisory panel gives Savient's Krystexxa a passing grade.  |
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 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 1, 2008 Brian Lawler |
A Competitive Stab at King and Pain A new, dark-horse competitor, privately held Purdue Pharma, arrives to fight King Pharma and Pain Therapeutics.  |
The Motley Fool April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.  |
The Motley Fool August 31, 2009 Brian Orelli |
Good Luck, Genzyme -- You'll Need It The drugmaker faces an FDA advisory-panel showdown regarding its leukemia drug Clolar.  |
The Motley Fool January 7, 2010 Brian Orelli |
Warning: Potential Anemic Growth Ahead Anemia-drug makers get more scrutiny from the FDA.  |
The Motley Fool June 16, 2008 Brian Orelli |
More Cancer Issues for Johnson & Johnson Potential cancer-causing side effects of Johnson & Johnson's drugs are like a tumor that continues to grow on the company.  |
The Motley Fool May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored.  |
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 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 November 28, 2008 Brian Orelli |
The FDA's Killing Bug Killers Unfortunately for Johnson & Johnson and Swiss drugmaker Basilea Pharmaceutica, the FDA appears a little reluctant to take some of the data for the drugmakers' antibiotic ceftobiprole at face value.  |
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 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 January 21, 2011 Brian Orelli |
Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir.  |
The Motley Fool December 7, 2007 Brian Lawler |
Pain Continues as Planned Pain Therapeutics reports on a successful phase 3 trial for its lead drug Remoxy.  |
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 May 25, 2011 Brian Orelli |
Optimer's Upcoming FDA Decision: Memorable or Memorial? We'll know on Memorial Day, plus or minus a few days.  |
The Motley Fool December 3, 2010 Brian Orelli |
Obesity Drug Companies Are (Still) Risky Orexigen heads before an FDA panel.  |
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 September 15, 2010 Brian Orelli |
Drug Approved. Now Let's Sell This Baby! With ink still wet on its FDA approval, Savient continues its plan to find a buyer.  |
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 6, 2012 David Williamson |
Durect Investors Feel the Pain A phase 3 failure of a lead drug crushes shares.  |
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 18, 2010 Brian Orelli |
More Pain Ahead for Eli Lilly? An advisory panel meeting tomorrow could further the company's slide.  |
The Motley Fool December 31, 2009 Brian Orelli |
The FDA (Still) Hates Antibiotic Makers Johnson & Johnson and Basilea are the agency's latest victims.  |
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 June 24, 2011 Brian Orelli |
Come on, Pfizer, Not Even a Little Hint? Remoxy is rejected, but why?  |
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 May 29, 2007 Brian Lawler |
The One Development-Stage Drug Stock to Own Now With such a low level of Remoxy sales baked into its share price, and minimal clinical trial risk, investors who consider Pain Therapeutics around today's share price won't be hurting in the long run, if you assume there will be a viable market for abuse-resistant opioids.  |
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 June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.  |
The Motley Fool November 10, 2009 Brian Orelli |
3 Companies Looking for Gratitude Early These three small drug companies all have PDUFA dates in the next week: Cadence Pharmaceuticals... NeurogesX... Genzyme...  |
The Motley Fool September 2, 2010 Brian Orelli |
Fatter Wallet. Up 22%. Still Risky. After VIVUS' Qnexa was shot down at its FDA advisory panel, it's clear that Arena and Orexigen have an uphill battle in front of them.  |