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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 August 31, 2010 Brian Orelli	A Mostly Meaningless FDA Rejection The Food and Drug Administration sends AstraZeneca back to the drawing board for the second time when it rejected motavizumab, the drugmaker's newest treatment for respiratory syncytial virus.
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 March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
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 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 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 January 7, 2010 Brian Orelli	Warning: Potential Anemic Growth Ahead Anemia-drug makers get more scrutiny from the FDA.
The Motley Fool March 3, 2009 Brian Orelli	Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think.
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 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 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 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 December 9, 2008 Brian Orelli	Presents or Coal From the FDA? Let's take a look at a few companies expecting FDA decisions this month and see whether they're more likely to get a present or a lump of coal in their marketing-application stockings.
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 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 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 November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
The Motley Fool June 16, 2009 Brian Orelli	Going Viral, but Not in a Good Way Genzyme's manufacturing problems with viruses underscore the complexity of manufacturing biologic drugs compared to small molecule drugs.
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 April 24, 2008 Brian Lawler	FDA Stings Genzyme Earnings A nasty surprise hurts the drug developer's first quarter results.
The Motley Fool August 29, 2011 Brian Orelli	A Less Painful FDA Decision Johnson & Johnson gains approval of Nucynta ER.
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 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 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 December 31, 2009 Brian Orelli	The FDA (Still) Hates Antibiotic Makers Johnson & Johnson and Basilea are the agency's latest victims.
The Motley Fool September 23, 2008 Brian Lawler	Will Generic Biologics Get Special Treatment? While the rest of the market was lost in the financial meltdown, a little-noticed report discussing some of the biopharmaceutical bills going through Congress was released.
Chemistry World April 24, 2008 James Mitchell Crow	FDA takes tough line on biologic drug The US Food and Drug Administration has rejected an application from biotechnology firm Genzyme to make its already-approved, protein-based drug Myozyme in larger batches.
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 March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
The Motley Fool July 1, 2008 Brian Orelli	As the FDA Generics Office Turns The FDA reluctantly gives Teva a 180-day exclusive period to sell generic Risperdal.
The Motley Fool May 3, 2010 Brian Orelli	While You Were Reveling in Dendreon's Win The FDA has approved Vimovo, an arthritis drug from Pozen and AstraZeneca, and Bristol-Myers Squibb also got a decision from the FDA, but it wasn't the positive kind.
The Motley Fool February 27, 2009 Brian Orelli	Double Approvals, Accelerated Growth Genzyme gets a pair of approvals -- one from each side of the Atlantic -- for two different products.
The Motley Fool January 26, 2009 Brian Orelli	Which One of These Is Not Like the Other? Bristol-Myers and Eli Lilly run into some comparability issues.
The Motley Fool December 2, 2009 Brian Orelli	Tired of Waiting, Teva Advances Teva Pharmaceutical decides it's not worth waiting for the U.S. government to establish a pathway for approval of generic versions of biologic drugs. Instead, it's asking for approval for its copycat of Amgen's Neupogen under the normal branded-drug process.
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 May 21, 2009 Robert Steyer	The AstraZeneca Dilemma Can AstraZeneca produce enough new drugs to offset a series of upcoming patent expirations?
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 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 30, 2010 Brian Orelli	2011 Drugmaker M&A Targets What Big Pharma M&A deals will 2011 hold? Most likely, more small deals, and perhaps Sanofi will finally offer a reasonable price for Genzyme. Let's take a look at some of the companies that might be walking down the aisle next year.
The Motley Fool January 28, 2011 Brian Orelli	Looking Ahead at Bristol-Myers Product approvals now will help with the upcoming patent cliff.
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 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 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 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, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
The Motley Fool November 26, 2010 Brian Orelli	Black Friday Biotech Bargains Drugmakers on sale.
The Motley Fool July 26, 2010 Brian Orelli	Up 20%! Guess That Hedge Wasn't Needed Onyx reports positive data for its recently acquired multiple myeloma drug.
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.