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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 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.
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 3, 2011 Brian Orelli	FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully.
The Motley Fool September 27, 2010 Brian Orelli	Now That's What I Call a Drug That Works Seattle Genetics hits a home run -- and then some -- with its cancer drug Brentuximab vedotin.
The Motley Fool April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin	Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.
Pharmaceutical Executive December 1, 2013	FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler.
The Motley Fool April 25, 2011 Luke Timmerman	Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it?
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.
Pharmaceutical Executive April 1, 2009 Patrick Clinton	Dear Commissioner... Unsolicited advice for FDA's next leader: Keep it real, fight popular delusions, and somehow, please, defend the agency.
The Motley Fool January 25, 2010 Brian Orelli	No Way to Hide This Drug Approval FDA trumps Acorda on its good news. The biotech announced Food and Drug Administration approval of Ampyra, its drug to help multiple sclerosis patients walk better after the markets closed on Friday.
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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
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 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 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.
Pharmaceutical Executive May 1, 2011 Jill Wechsler	Outrage Over Drug Prices Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies
HBS Working Knowledge August 10, 2015 Michael Blanding	New Medical Devices Get To Patients Too Slowly The FDA has streamlined drug testing to ensure new therapies come to market quickly. But when it comes to life-giving medical devices, approvals seem unnecessarily slow, according to research by Ariel Dora Stern.
The Motley Fool November 30, 2010 Brian Orelli	A Witty Response to Pharma's R&D Dilemma According to GlaxoSmithKline CEO Andrew Witty, the pharmaceutical industry is a mess. That's the basic gist of his opinion piece in The Economist.
The Motley Fool May 26, 2011 Brian Orelli	Congress Sets Bad Precedent With AVANIR What happened to free markets?
The Motley Fool September 24, 2008 Brian Orelli	Hey, You! Stop! The FDA has ordered Baxter and Hospira to stop making their ophthalmic balanced salt solutions within 60 days.
Chemistry World September 24, 2010 Andrew Turley	End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use.
Pharmaceutical Executive April 1, 2012 Feam & Lagus	Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
Pharmaceutical Executive October 1, 2011 Jill Wechsler	At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system.
The Motley Fool January 11, 2011 Brian Orelli	A Clear Drug-Development Path -- Times 2 The FDA throws a fork in the road for Isis and Genzyme.
Pharmaceutical Executive November 1, 2014 Jill Wechsler	Outrage Grows Over Drug Pricing Insurers, physicians attack high-cost therapies in anticipation of specialty drug surge.
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 February 23, 2005 John Reeves	Predicting the Next Wal-Mart Studying the history of disruptive innovation can help us find tomorrow's winners.
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 April 5, 2011 Brian Orelli	Obese Expectations Trump Great Data Sorry VIVUS and Orexigen, you're still not going to get your drugs approved quickly.
BusinessWeek December 13, 2004 John Carey	How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs.
The Motley Fool April 26, 2011 Brian Orelli	There Is Only Downside in Consensus Hepatitis C advisory panels will almost certainly recommend approval. Almost.
Pharmaceutical Executive June 1, 2014 Jill Wechsler	What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices.
The Motley Fool March 16, 2011 Brian Orelli	Different Name, Same Great Results Incyte and Novartis' ruxolitinib passes another clinical trial.
Pharmaceutical Executive July 1, 2009 Jill Wechsler	Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
The Motley Fool September 7, 2010 Luke Timmerman	Vertex Nails Third Big Trial With Hepatitis C Drug And in the toughest patients to treat, too.
Chemistry World May 5, 2015 Anthony King	Merger creates biggest supplier of unlicensed drugs Specialty pharma company Clinigen is to buy its rival Idis, making it the market leader in ethical unlicensed drug supply.
Pharmaceutical Executive February 1, 2013 Jill Wechsler	Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending.
The Motley Fool March 17, 2008 Brian Lawler	The Panelling on Amgen's Walls One FDA panel ruling is a win, another is much less upsetting than investors feared.
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 October 15, 2009 Mac Greer	Will Apple Lose Its Edge? Disruptive innovation expert Clay Christensen talks movers and shakers.
BusinessWeek June 16, 2011 Langreth & Cortez	When Two Cancer Drugs Are Better Than One Drugmakers are collaborating to test combinations of genetically targeted cancer drugs in hopes of boosting survival rates.
Chemistry World September 7, 2015	Cancer Drugs Fund axes 23 treatments The Cancer Drugs Fund, which covers the cost of some cancer treatments that are not currently available on the National Health Service, has cut 23 treatments -- involving 16 drugs.
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 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.