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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 December 15, 2003 Mark D. Uehling	Model Patient Despite the FDA's new support for computational modeling, the pharmaceutical industry remains cautious about simulating clinical trials.
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 July 29, 2010 Brian Orelli	This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either.
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 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.
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?
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
Bio-IT World Jul/Aug 2006 John Russell	Pharsight CRADA to Assist FDA with Modeling Initiative Pharsight will use FDA's feedback to further develop their server to meet drug-maker's analysis requirements, and further develop their visualization and collaboration tool to support FDA-sponsor interactions for the visualization and communication of model-based product profiles.
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 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 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 September 14, 2010 Luke Timmerman	Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug.
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 February 2006 John Russell	Marvelous Models of Biological Systems Here are highlights from a roundtable discussion with researchers representing academia and pharmaceuticals, as well as executives from modeling technology providers on whether or not Pharma is ready to bet on computational modeling of biological systems.
Bio-IT World November 12, 2002 Michael Goldman	A Virtual Pharmacopeia Computational modeling of disease pathways, organs --- even patients --- could transform drug discovery. Does salvation exist in silico?
The Motley Fool January 28, 2011 Brian Orelli	Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result.
The Motley Fool July 27, 2010 Jim Mueller	3 Stocks to Play Biotech Here are three promising ideas for this exciting area.
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.
The Motley Fool October 19, 2010 Brian Orelli	Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency.
The Motley Fool November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
The Motley Fool April 1, 2004 Charly Travers	Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration.
The Motley Fool July 13, 2011 Brian Orelli	2 Questions for Seattle Genetics So far the FDA is fairly impressed with Seattle Genetics' lymphompa drug brentuximab vedotin.
The Motley Fool October 27, 2010 Ralph Casale	Companion Diagnostics in Cancer Drug Development Diagnostic companies partnering with drug developers can make for an attractive investment segment.
The Motley Fool September 8, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
Bio-IT World September 2006 John Russell	Predicting the Future of Systems Biology Buoyed by promising results from a recent collaboration with Pfizer on drug-induced vascular injury, Keith Elliston, CEO of modeling and biosimulation specialist Genstruct, offers a candid view of industry's flirtation with systems biology and the future prospects for the field.
The Motley Fool December 31, 2011 Brian Orelli	3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.
The Motley Fool February 23, 2010 Brian Orelli	The One That Didn't Get Away After some encouragement, the FDA approves Gilead's Cayston.
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.
Bio-IT World September 2006 John Russell	Informatics Cornucopia Predictive Informatics, the hopeful title of a session at last month's Drug Discovery Technology & Development World Congress, remains an enticing but mostly elusive goal. Asked what systems biology would look in five years and what will constitute success, panelists offered the following.
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.
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.
Pharmaceutical Executive September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
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 September 17, 2010 Luke Timmerman	Cell Therapeutics OK'd to Sell Shares to Stay Alive Is the company being straight with shareholders?
Pharmaceutical Executive May 1, 2007 Weiner & Hovde	Critical Mass for Critical Path? Everyone agrees that it's the road to pharma's future, but no one's rushing to take it. Yet with growing FDA advocacy and new advances in biomarkers and drug-disease modeling, the rewards of collaboration now look greater than the risks.
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.
Bio-IT World Dec 2006/Jan 2007 John Russell	Setting the Systems Bio Syllabus An interview with David de Graaf about Pfizer's growing comfort with systems biology.
Bio-IT World Jul/Aug 2006 Kevin Davies	Beyond the Last Chromosome About 700 attendees gathered Beyond Genome 2006, one of Cambridge Healthtech Institute's flagship conferences, to discuss the major technology trends in postgenomic biology, including systems biology, RNAi, proteomics, and personalized medicine.
The Motley Fool February 11, 2011 Brian Orelli	Biotech Optimists Throw In the Towel As the chance of survival improves, the stock falls. Wait, what?
Fast Company December 2009 Elizabeth Svoboda	Biotechs Look Overseas to Launch a Stem-Cell Revolution According to one small biotech, the best way to launch a stem-cell revolution is to do it overseas.
The Motley Fool July 14, 2010 Luke Timmerman	Vivus Faces Turning Point Tomorrow Thursday's the big day. All eyes will be on Vivus and the FDA's decision on their new obesity drug
The Motley Fool December 3, 2010 Travis Hoium	Orexigen Therapeutics Shares Plunged: What You Need to Know Shares of biopharmaceutical company Orexigen Therapeutics fell 10% today after a Food and Drug Administration announcement.
The Motley Fool May 27, 2011 Brian Orelli	Don't Believe the Obesity Hype Meta-analysis data isn't going to help Arena Pharmaceuticals' obesity drug.
The Motley Fool December 31, 2011 Brian Orelli	3 More Stock-Moving Binary Events to Watch in 2012 There are a lot of drugs that will face binary events in 2012 -- here are three to watch.
The Motley Fool May 13, 2011 Brian Orelli	FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved.
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 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 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.
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.