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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 October 11, 2010 Brian Orelli |
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that.  |
The Motley Fool January 27, 2009 Robert Steyer |
Another Angle for Fibromyalgia In the past 18 months, the FDA has approved three drugs that can be used to treat the disease. Which pharma companies will benefit?  |
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 24, 2009 Brian Orelli |
Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety.  |
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 February 25, 2008 Brian Lawler |
The Most Interesting FDA Review for 2008 Eli Lilly preps for an upcoming FDA review of its top pipeline drug, the blood thinner prasugrel.  |
The Motley Fool January 29, 2009 Brian Orelli |
Lilly's in Need of a Pep Pill Eli Lilly's quarterly earnings report was pretty boring. Some drugs were up and others were down -- the end result was flat sales.  |
The Motley Fool September 30, 2008 Brian Lawler |
No Approval for You ... Yet The FDA makes Eli Lilly wait for word on a lead drug.  |
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 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 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 December 30, 2008 Brian Orelli |
The FDA Needs a Bake Sale Money seems to be at the root of the problem with the FDA right now. It's pretty clear that fees, even though they're up to over $1 million per marketing application, aren't enough to get things done in a timely manner.  |
The Motley Fool September 1, 2004 W.D. Crotty |
A Pall Falls Over Forest One of Forest Labs' Alzheimer's drugs fails in phase 3 trials. For investors willing to take the political risk, today's drug news has taken a battered stock, with a great balance sheet, to very reasonable price levels.  |
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 November 5, 2010 Brian Orelli |
Better Late Than Never for Cymbalta Eli Lilly gets an expanded approval for Cymbalta.  |
The Motley Fool February 25, 2009 Brian Orelli |
Pfizer Doesn't Like Reruns The company drops two drugs that had made it as far as phase 3 trials.  |
The Motley Fool January 28, 2011 Brian Orelli |
Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result.  |
The Motley Fool February 3, 2010 Brian Orelli |
Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease.  |
The Motley Fool December 1, 2008 Brian Orelli |
It's Wait Until Next Year for These Drugmakers Drugs from AstraZeneca and Eli Lilly face delays because of the FDA. Both plan to resubmit their applications for approval in the first half of next year, but the delays likely will have different effects on the companies.  |
The Motley Fool July 13, 2009 Brian Orelli |
Finally! It's a Win, Isn't It? Eli Lilly and marketing partner Daiichi Sankyo finally got a Food and Drug Administration approval of their blood thinner, Effient (prasugrel), on Friday afternoon.  |
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 December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.  |
The Motley Fool October 30, 2007 Billy Fisher |
Is Forest Labs' Nebivolol Ready for Prime Time? Shareholders of the pharmaceutical company have been looking for a way to boost their floundering stock. The FDA's likely approval of hypertension drug Nebivolol may be the answer.  |
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 June 25, 2008 Brian Lawler |
Why the Lilly Delay, FDA? A government review of the company's top drug candidate gets pushed back.  |
The Motley Fool June 2, 2010 Brian Orelli |
Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market.  |
The Motley Fool December 31, 2008 Brian Orelli |
An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel.  |
The Motley Fool November 16, 2009 Brian Orelli |
Music to Health-Care Investors' Ears Are faster FDA review times coming?  |
The Motley Fool August 27, 2010 Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen.  |
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 December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.  |
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 August 20, 2010 Brian Orelli |
Depression Is Painful. Advisory Panels More So. Eli Lilly's Cymbalta has a rough time in from of the panel of experts.  |
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 December 3, 2007 Brian Orelli |
Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol.  |
The Motley Fool April 5, 2010 Brian Orelli |
Up 30%? What Are You People On? Fast-track designations aren't worth much more than the paper they're printed on.  |
The Motley Fool February 27, 2009 Brian Orelli |
Get a Life, Congress! A Congressional investigation into whether the FDA was right to pull a doctor off of the advisory panel for Eli Lilly's blood thinner prasugrel illustrates why Congress needs to keep its nose out of scientific discussions.  |
The Motley Fool August 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals  |
The Motley Fool November 24, 2010 Brian Orelli |
A Manly FDA Approval Eli Lilly has something to be thankful for this week; the Food and Drug Administration approved Axiron, its testosterone replacement therapy.  |
The Motley Fool July 13, 2011 Brian Orelli |
2 Questions for Seattle Genetics So far the FDA is fairly impressed with Seattle Genetics' lymphompa drug brentuximab vedotin.  |
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 5, 2008 Brian Orelli |
Be Kind to MannKind MannKind has good data on its inhaled insulin drug, but will the FDA approve of it and will diabetics buy it?  |
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 September 29, 2011 Brian Orelli |
Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA.  |
The Motley Fool June 30, 2004 Alyce Lomax |
A Monster Drug for Lilly? The drug giant files a new drug application (NDA) for its experimental new drug for diabetics.  |
The Motley Fool October 20, 2010 Brian Orelli |
There Are No Safe Biotech Investments Amylin Pharmaceuticals and its partners, Eli Lilly and Alkermes, announced yesterday evening that the Food and Drug Administration had asked for more data before approving its once-weekly diabetes drug Bydureon.  |
The Motley Fool May 23, 2007 Mike Havrilla |
Cypress Bioscience Comes Full Circle A potential treatment for fibromyalgia sent shares close to $17 today.  |
The Motley Fool December 19, 2008 Brian Orelli |
Eli Lilly's Good News Misses the Mark EU approval of its blood thinner is nice, but U.S. approval is what will really matter.  |
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.  |