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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 February 25, 2011 Brian Orelli |
Minor Delay, Major Missed Opportunity Protalix and Pfizer's Gaucher disease drug gets delayed. |
The Motley Fool December 1, 2009 Brian Orelli |
Pfizer Takes In an Orphan on the Cheap Steal is a pretty accurate term for the price Pfizer paid for Protalix BioTherapeutics' taliglucerase alfa. |
The Motley Fool December 6, 2011 Travis Hoium |
Protalix BioTherapeutics Shares Got Crushed: What You Need to Know Is this meaningful or just another movement for Protalix BioTherapeutics? |
The Motley Fool November 29, 2010 Travis Hoium |
Protalix BioTherapeutics Shares Popped: What You Need to Know Shares of biopharmaceutical company Protalix BioTherapeutics jumped 10% this morning after the company announced a European application for taliglucerase alfa. |
The Motley Fool November 19, 2009 Brian Orelli |
This Stock Is a Train Wreck Genzyme's string of missteps has investors nervous. |
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 24, 2008 Brian Lawler |
FDA Stings Genzyme Earnings A nasty surprise hurts the drug developer's first quarter results. |
The Motley Fool September 2, 2010 Brian Orelli |
Pfizer Takes an Orphan Into the Fold Pfizer is likely pursuing FoldRx's pipeline and expertise in rare diseases. |
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 15, 2006 Brian Lawler |
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. |
The Motley Fool February 28, 2011 Brian Orelli |
Rare Diseases, Big Opportunity "Orphan" drugs to keep your eye on. |
The Motley Fool October 22, 2009 Brian Orelli |
The Gift That Keeps on Giving Genzyme's manufacturing issues just won't go away. Four months after the company announced that it had shut down a manufacturing plant because of viral contamination, its stock is still dealing with the aftermath. |
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 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 August 9, 2010 Brian Orelli |
Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble." |
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 May 25, 2007 Brian Lawler |
BioMarin Waits for Another Drug BioMarin files a marketing application for its lead compound in development. Investors, take note. |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
The Motley Fool May 26, 2010 Brian Orelli |
Is This 4,000-Liter Bioreactor Half-Full? Or half-empty? Only time will tell for Genzyme. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
The Motley Fool January 16, 2008 Brian Orelli |
Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know. |
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 22, 2011 Brian Orelli |
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. |
The Motley Fool November 18, 2008 Brian Orelli |
Genzyme Grounded for Thanksgiving The biotech won't get a decision on Myozyme until February. |
The Motley Fool May 15, 2008 Brian Orelli |
Wanted: FDA Approval -- Pronto Teva and Amphastar have the courts on their side, but the FDA still stands in the way of a generic-drug launch. |
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 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 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 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 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 November 3, 2009 Brian Orelli |
A Little Distracted, Are You, Merck? The FDA rejects its latest application. |
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 February 21, 2008 Brian Lawler |
A Bit of Irony From the FDA The agency has a mixed message on drug importation, as evidenced in the recent possible contamination of China-produced Heparin. |
The Motley Fool April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. |
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 October 10, 2005 Stephen D. Simpson |
The FDA: Boon, Bane, Whipping Boy Everyone wants the FDA to be faster, better, and cheaper, but that may not be a credible expectation. Investors would do well to keep an eye on the FDA because its policies and pressures ultimately filter down to our medicine cabinets, wallets, and portfolios. |
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 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 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 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 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 August 12, 2008 Brian Lawler |
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
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 February 17, 2010 Brian Orelli |
Execute Well or You're Out Genzyme needs to show investors that it can rebuild. |
The Motley Fool August 22, 2007 Brian Orelli |
Regulating the Drug Pushers The FDA might get a little tougher on drug ads, following a report that they may not be watching advertisers claims closely enough, or warning patients about side effects strongly enough. |
The Motley Fool August 9, 2007 Brian Lawler |
BioMarin Gets Busy BioMarin Pharmaceutical has a busy remainder of 2007 ahead of it, including regulatory decisions, six clinical trials, and the potential for new products to enter the pipeline. |
The Motley Fool March 3, 2011 Ryan McBride |
With Sanofi Buyout of Genzyme, Rare Disease Execs Upbeat About Interest in Their Niche The field might benefit from the increased interest in it among pharmaceutical players. |
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. |