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BusinessWeek November 29, 2004 Carey & Barrett	Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do.
BusinessWeek March 7, 2005 John Carey	Side Effects Of The Drug Scares New fears give rise to a more honest look at the risks for a pill-popping nation.
BusinessWeek February 9, 2004 John Carey	Drug Ads Need Stronger Medicine New FDA guidelines may not go far enough in making sure pharmaceutical ads are used appropriately.
The Motley Fool May 21, 2010 Brian Orelli	And You Thought Biotech Was High-Risk, High-Reward Large clinical trials make cardiovascular drugs risky, but the rewards are there, too.
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.
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 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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
CIO March 15, 2006 Allan Holmes	Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market.
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 August 31, 2010 Brian Orelli	Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior.
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.
BusinessWeek May 21, 2007 John Carey	A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it?
BusinessWeek May 27, 2010 Michelle Cortez	Karo Bio's Prescription: Cheaper Drug Approval A Swedish company seeks a lower-cost review for its cholesterol drug.
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.
Bio-IT World December 15, 2004 Kevin Davies	Patients Before Profits? After the Vioxx disaster, Pharma needs to reassure patients that they come first.
BusinessWeek February 28, 2005 Capell & Carey	A Drug Watchdog To Rival The FDA Europe's agency will soon have new powers. Will it take the lead on safety?
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 December 27, 2004 W.D. Crotty	Drug Safety: Investors Beware Will AstraZeneca become the latest casualty in the drug safety debate?
Pharmaceutical Executive March 1, 2007 Jill Wechsler	Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process.
The Motley Fool November 30, 2007 Brian Orelli	Clinical Trial Failures Don't Bother These Companies Contract research organizations, outsourcing companies hired by pharmaceutical and biotech companies to run pre-clinical tests and clinical trials for them, succeed even when drugs fail, and more work may be coming their way.
Pharmaceutical Executive June 1, 2006 Jill Wechsler	Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.
The Motley Fool January 28, 2005 Karl Thiel	Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous.
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 May 31, 2011 Brian Orelli	5 Biotechs With Upcoming Clinical Trial Results Investors willing to stay in these stocks a little while could see substantial gains well ahead of FDA approvals.
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.
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 April 26, 2011 Luke Timmerman	FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex?
Pharmaceutical Executive April 1, 2005	Thought Leader: Better Business: Balancing Benefit, Risk, and Cost An interview with author and Harvard Medical School professor Dr. Jerry Avorn on how losing track of patient welfare and failing to address important safety problems isn't just bad science and bad ethics, it's also bad business.
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.
Pharmaceutical Executive January 1, 2009 Jill Wechsler	FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order?
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.
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.
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.
The Motley Fool January 14, 2011 Brian Orelli	Don't Have a Stroke Over Merck's Heart Drug Welcome to pharma investing.
Managed Care July 2005 Martin Sipkoff	Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules.
The Motley Fool June 30, 2010 Brian Orelli	When Researchers Attack, Investors Lose Drug investors have to watch out for a lot of things that can change their stock's price: earnings reports, clinical trial results, competitor's results, and FDA decisions.
BusinessWeek October 18, 2004 Catherine Arnst	The Waning of the Blockbuster Drug What's promising now are drugs that target niche diseases. That means painful restructuring ahead for Big Pharma
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.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
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 December 4, 2007 Brian Orelli	An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications.
The Motley Fool August 27, 2010 Brian Orelli	Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen.
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.
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.
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.
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
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 November 16, 2007 Brian Lawler	Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx.
The Motley Fool July 17, 2007 Brian Orelli	An Investor's Guide to the New PDUFA It's important for investors in drug companies to keep up with the latest clinical trial news, but policy changes in Washington can affect companies' bottom lines just as much.