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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.
Pharmaceutical Executive July 3, 2007 Louis A. Morris	Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way.
Pharmaceutical Executive February 1, 2011 Jennifer Ringler	Skipping the Needle: Pharm Exec's Brand of the Year Novartis' Gilenya is a step forward in treating Multiple Sclerosis. But generating increased compliance is another story
Pharmaceutical Executive November 1, 2012 Sue Barrowcliffe	Real World Insights Commercial teams as well as patients can benefit from managed access programs, which are designed to provide access to medicines outside of the clinical and commercial setting, for patients who have no other available treatment options.
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 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 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 June 1, 2007 Clinton & Wechsler	The View From Inside Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine.
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, 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 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 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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
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.
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 September 22, 2010 Jordan DiPietro	A Huge Victory for Novartis MS oral drug is approved.
The Motley Fool June 3, 2011 Luke Timmerman	Orexigen, Facing High Hurdle at FDA, Puts Obesity Drug Development on Hold The close attention paid to safety makes this drug difficult to get right.
The Motley Fool March 28, 2011 Brian Orelli	Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news.
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 28, 2011 Brian Orelli	Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval.
The Motley Fool September 23, 2010 Brian Orelli	A Blockbuster in Due Time Novartis' new multiple sclerosis drug, Gilenya, isn't king yet.
Pharmaceutical Executive April 1, 2006 Jill Wechsler	Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf?
The Motley Fool August 9, 2010 Luke Timmerman	Affymax Lives to Fight Another Day Affymax takes on Amgen with its anemia drug.
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 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.
Pharmaceutical Executive March 1, 2011 Jill Wechsler	New Tools Track Safety, Value in Medicine FDA's Sentinel Initiative raises broader questions about tapping patient information and health IT for comparative studies in drug development.
The Motley Fool April 13, 2011 Brian Orelli	Abbott's Potential Billion-Dollar Problem Abbott's Humira forms antibodies in nearly a quarter of patients.
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 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
Pharmaceutical Executive December 1, 2010	The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator The European Medicines Agency is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs.
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.
Pharmaceutical Executive April 1, 2007 McCook & Daniels	Making the Switch More companies are using Rx-to-OTC switches to extend a brand's life cycle. Prilosec did it. Here, experts dish on how you can do it too.
The Motley Fool November 16, 2010 Luke Timmerman	Anthera Seeks to Tap Heart Attack Market by Blocking Inflammation Anthera has some work to do to make sure its new drug wins big.
Pharmaceutical Executive March 1, 2013 Ben Comer	Brand of the Year: Januvia When Merck's Januvia received its first regulatory approval, in Mexico in 2006, no one predicted its long-term success. In 2012, the company's diabetes franchise became the highest-selling product family in Merck's 122-year history.
Pharmaceutical Executive September 1, 2011 Richard Gliklich	The Power of Observation Observational studies present a compelling real-world corollary to the classic randomized clinical trial.
The Motley Fool July 16, 2010 Tom Hughes	Lessons Learned About the Outlook for New Obesity Drug Approval The recent FDA advisory committee meeting on Vivus' weight loss pill proved to us, once again, how incredibly difficult it is to successfully develop and register new drugs for obesity.
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?
Chemistry World March 15, 2011 Sarah Houlton	Benlysta breaks 50 year Lupus drug drought The first new treatment for lupus erythematosus in half a century has been approved by the US Food and Drug Administration
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.
Pharmaceutical Executive November 1, 2013	Roundtable on Market Access Market Access is a window on what matters in the real world of soaring patient expectations and crimped payer budgets for innovation.
The Motley Fool January 7, 2010 Brian Orelli	Warning: Potential Anemic Growth Ahead Anemia-drug makers get more scrutiny from the FDA.
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 March 3, 2011 Brian Orelli	3 Cheers for an FDA Rejection German drugmaker Merck said that the Food and Drug Administration had turned down its multiple sclerosis drug cladribine. The pill would have competed with Novartis' Gilenya, which gained FDA approval last year.
The Motley Fool March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
Pharmaceutical Executive August 1, 2008 Jill Wechsler	Can Sentinel Save Drug Development? FDA's new sentinel system shows the pendulum swing toward safety won't swing back anytime soon.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
The Motley Fool June 8, 2010 Brian Orelli	Injecting Uncertainty Into the Multiple Sclerosis Market Novartis' oral MS drug could be a blockbuster -- if it can get past the FDA.
Reason October 2007 Ronald Bailey	Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest."
BusinessWeek January 21, 2010 John Carey	Making Personalized Medicine Pay Medco and other pharmacy benefit managers say future profits depend on matching drugs to patients based on their genes.
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.