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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 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.
Bio-IT World March 17, 2004 Zachary Zimmerman	Testing Times for the FDA The FDA's pharmacogenomic guidance marks the beginning of a long process toward standardized tests.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
Bio-IT World December 15, 2003 Kevin Davies	The Road to Personalized Medicine FDA guidance on the road to genomic medicine is a welcome first step in what promises to be a contentious debate on how to integrate pharmacogenomics into routine medical practice.
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.
Investment Advisor December 2005 Greg B. Scott	Buying The Future Prudent investing in biotechnology can offer great returns for clients. It's also the wave of the future. Armed with a basic understanding of the dynamics of the industry and the valuation inflection points, intelligent investors can make significant returns.
Bio-IT World July 11, 2002 Kevin Davies	Counting the Cost of Drug Discovery Much of the trouble ensnaring the drug industry is blamed on the exorbitant cost of drug discovery. Tangible proof that the bio-IT revolution will economize drug discovery is emerging, but there is still a long way to go.
The Motley Fool July 8, 2008 Brian Lawler	Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards.
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?
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.
BusinessWeek September 5, 2005	Putting the FDA Out Front Deputy Commissioner Dr. Janet Woodcock explains how the agency has led the drive for personalized medicine.
The Motley Fool August 31, 2010 Brian Orelli	Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior.
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 January 26, 2005 Stephen D. Simpson	The Pipeline to Biotech Success Looking at drug R&D is the best way to begin assessing biotech companies as possible investment opportunities.
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.
Bio-IT World April 2007 Malorye Allison	Biomarkers versus Blockbusters Are companies really changing their strategies and using biomarkers to target smaller, better defined patient sets with their new drugs? Or is the vast majority of pharma biomarker studies just aimed at culling bad drugs from their pipelines?
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.
Bio-IT World June 12, 2002 Morris R. Levitt	A New Economic Paradigm for Bio-IT? All who work in the bio-IT industry -- scientists, IT and informatics managers, and executives -- have been aware for some time that we seem to be suspended between an acute sense of crisis and a field of boundless opportunity.
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.
Chemistry World September 11, 2012 Maria Burke	Orphan drugs set for 'tremendous growth' A new report by Thomson Reuters offers clear confirmation that developing drugs for rare, or orphan, diseases is economically attractive, despite the smaller patient pool.
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 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.
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 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 October 9, 2006 Brian Lawler	The Commandments of Biotech Investing, Part 2 It's a complex field, but it's not impossible for investors to master. The more in-depth your research of a potential biotech investment, and the more you remember to follow these commandments, the better your potential for success will be when investing in this fascinating field.
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 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 July 12, 2010 Ryan McBride	Synta Pharma CEO Trumpets New Top Cancer Drug Synta Pharmaceuticals has been climbing back from one of the Boston area's highest-profile clinical trial failures of 2009.
Bio-IT World August 13, 2002 Mark D. Uehling	Clinical Trial Data Management: Tortured by Paper Reams of paper stuffed into boxes and shipped to the FDA by the truckload is hardly the best approach to drug approval. But what's the right way?
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 November 1, 2011 Elizabeth O. Coulton	Clinical Trial Issues Not Just Black and White The selection of clinical trial participants must meld with the changing demographics of America if industry is to improve medicines that work for patients.
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
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 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 4, 2007 Brian Orelli	An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications.
Chemistry World November 20, 2014 Rebecca Trager	US drug development costs surge Developing and winning market approval for a new prescription drug in the US takes about a decade and costs approximately $2.6 billion, according to data released by Tufts University researchers.
The Motley Fool April 16, 2010 Brian Orelli	It'll Be a Blockbuster! High Fives All Around, Right? Sanofi-aventis releases top-line data for its phase 3 diabetes drug candidate, lixisenatide. The trial was a success, but don't pencil it in as a blockbuster just yet.
Pharmaceutical Executive November 1, 2014 William Looney	Pharma Science: It's Hard Amid a resurgence in drug development for hard-to-treat conditions, the bigger question is whether the times are as good for the industry tasked with rendering basic science into therapeutically effective medicines.
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.
Bio-IT World June 12, 2002 Malorye Branca	FDA Fosters Pharmacogenomics One reason pharmaceutical companies have been slow to embrace pharmacogenomics is the fear that it will be difficult to get such products through the FDA. Lawrence J. Lesko, director of the FDA's Office of clinical pharmacology and biopharmaceutics, talks about his hopes for the field.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
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 December 27, 2010 Brian Orelli	Painful Clinical Hold? Not Really. Regeneron offers the benefits of a full pipeline.
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 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 May 11, 2010 Ryan McBride	Clinical Data Seeks to Challenge Lilly, Pfizer in Antidepressant Market The tiny drug developer has no problem going up against bigger rivals.
Bio-IT World November 14, 2003 Kathy Ordonez	Targeted Medicine via Molecular Diagnostics Using diagnostics to select and deselect target populations for drug therapy will enable life scientists to make more effective medicines.
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
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.