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The Motley Fool February 28, 2011 Brian Orelli	Rare Diseases, Big Opportunity "Orphan" drugs to keep your eye on.
The Motley Fool May 21, 2007 Brian Lawler	DUSA's Orphan Isn't Unique The pharmaceutical gets "orphan drug" status for its lead compound. Investors, take note.
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 July 24, 2009 Brian Orelli	Juicing Up the Earnings Report How did Celgene turn an earnings release that met analysts' expectations while lowering revenue guidance on one of its drugs into an 18.6% increase in share price yesterday?
The Motley Fool June 6, 2011 Brian Orelli	Big Pharma Tackles Lung Cancer; Biotech Helping, Too A big underserved market.
The Motley Fool March 28, 2007 Brian Lawler	Nuvelo Gets Fast One of Nuvelo's compounds gets fast track designation. Investors, take note.
The Motley Fool June 15, 2010 Brian Orelli	Just Enough to Give Investors Hope Hitting a secondary endpoint means all is not lost for Onyx's lung cancer drug.
The Motley Fool March 21, 2011 Brian Orelli	Let's See Some Data, Curis Curis investors seem to have shrugged off the multiple unknowns and embraced the potential for the company's skin cancer drug.
The Motley Fool July 28, 2010 Jordan DiPietro	3 Biotechs on Your Radar Screen It's not easy keeping track of all the drugs coming in and out of the development pipeline, but if you can stay up to date, you often have an advantage
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 April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
The Motley Fool August 29, 2011 Brian Orelli	Drug Approved for Few Patients -- but That's OK The age of personalized medicine is upon us. Earlier this month, the FDA approved Roche's melanoma drug Zelboraf for patients with a specific mutation in BRAF. And on Friday, the agency approved Pfizer's Xalkori for lung cancer patients that are ALK-positive.
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 January 28, 2011 Brian Orelli	Celgene Needs a Rocket Ship Celgene really needs a hit from Abraxane and other drugs it may license or purchase.
The Motley Fool May 2, 2011 Tim Beyers	Spectrum Pharmaceuticals Shares Popped: What You Need to Know Shares of Spectrum Pharmaceuticals rose as much as 14% in intraday trading after the Food and Drug Administration approved Fusilev as a colon cancer treatment.
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 March 30, 2010 Brian Orelli	Invest in This Space at Your Own Risk Lung cancer is a tough foe for drugmakers.
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 September 17, 2010 Luke Timmerman	Cell Therapeutics OK'd to Sell Shares to Stay Alive Is the company being straight with shareholders?
The Motley Fool April 8, 2011 Brian Orelli	A Shutdown of Binary Events? A government shutdown will likely stop FDA approvals.
The Motley Fool May 31, 2011 Brian Orelli	Profit From This Growing Drug Trend Cancer drugs press on.
The Motley Fool April 27, 2011 Brian Orelli	Falling Into the Zaltrap Lung cancer out, colon cancer in phase 3 clinical trial for Regeneron Pharmaceuticals' new drug.
The Motley Fool February 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.
The Motley Fool December 20, 2004 Charly Travers	More Trouble at Big Pharma AstraZeneca's lung cancer drug is not as effective as once hoped.
The Motley Fool May 10, 2011 Brian Orelli	Uncontrolled Crying Over AVANIR's Prescription Data? It's been a slow start, but don't write off this company's pseudobulbar drug just yet.
The Motley Fool September 15, 2010 Brian Orelli	Cell Therapeutics Goes for Broke If Cell Therapeutics can't get new funding soon, long-term consequences may be the least of its worries; time on the clock looks to be running out.
The Motley Fool February 18, 2010 Brian Orelli	Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance.
The Motley Fool July 6, 2009 Brian Orelli	Lilly Shows Us How It's Done The company announces that the Food and Drug Administration had expanded the approval of its cancer drug, Alimta, to include maintenance therapy for nonsquamous, non-small cell lung cancer.
The Motley Fool January 11, 2011 Brian Orelli	An Undeserved Kick in the Pants Celgene gets knocked around.
The Motley Fool December 8, 2010 Brian Orelli	Winners and Losers at the Hematology Society Meeting The American Society of Hematology annual meeting wrapped up yesterday, and as with pretty much every medical meeting, we've got some winning and losing blood-cancer drugs.
The Motley Fool January 31, 2008 Brian Lawler	Prioritizing Millennium The FDA grants a speedy review for Millennium Pharmaceuticals's lead multiple myeloma drug.
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 June 9, 2010 Brian Orelli	ASCO Pops and Drops Themes and company news from the annual meeting of the American Society of Clinical Oncology.
The Motley Fool November 29, 2011 Brian Orelli	Winners and Losers of Roche's Avastin Woes What the FDA giveth, the FDA can taketh away.
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 August 27, 2007 Brian Lawler	Round 2 for Genentech Learn a lesson or two from Genentech's's dance with the FDA. The drugmaker's experience serves as a reminder of the fickle nature of the government agency, and the sometimes frustrating process of bringing a medication to market.
Chemistry World June 22, 2011 Sarah Houlton	US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe.
The Motley Fool June 30, 2010 Brian Orelli	Celgene Jumps on a Platform Investors don't seem too enamored with Celgene's announcement that it's purchasing fellow cancer drugmaker Abraxis Bioscience although it looks like a good move in the long term.
The Motley Fool May 27, 2010 Brian Orelli	This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do.
Managed Care September 2004 Thomas Morrow	Orphan Drug Act Treatments Deserve Full Insurance Coverage An important federal law encourages development of drugs for populations so small that the market would otherwise ignore them. Should they not then be covered?
The Motley Fool May 24, 2010 Brian Orelli	ASCO Abstracts -- Pops and Drops! Ever since The American Society of Clinical Oncology began posting abstracts on-line -- and before that when they were sent to attendees -- investors have clamored to get a glimpse at the data. Here's your glimpse.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
The Motley Fool May 28, 2010 Brian Orelli	This Drug Doesn't Work. But All Is Not Lost. Novartis cancer drug fails one trial, but there's still hope.
BusinessWeek August 26, 2010 Tom Randall	Cocktails Are Next For Cancer-Drug Makers Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer.
The Motley Fool August 9, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
The Motley Fool February 25, 2008 Brian Lawler	A Positive Surprise for Genentech Biopharma Genentech's lead drug gets a conditional OK to treat breast cancer.
The Motley Fool March 30, 2011 Brian Orelli	Amgen's Long Shot Comes Up Short Amgen and Takeda Pharmaceutical's motesanib didn't extend overall survival in lung cancer patients when combined with Bristol-Myers Squibb's Taxol and carboplatin.
BusinessWeek April 2, 2007 Gene G. Marcial	Advanced Life Sciences Is Advancing On Anthrax Investors who stuck with Advanced Life Sciences even after it delayed completion of Phase 3 clinical trials on cethromycin felt rewarded when the Food & Drug Administration granted it "Orphan Drug" designation.
The Motley Fool July 2, 2008 Brian Lawler	DURECT's Intriguing Little Orphan An exciting pain drug inches onward in development.
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.