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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? |
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. |
Bio-IT World June 2006 Mark D. Uehling |
Real-Time Trials Currently, there is more visibility into the precise location of a FedEx package than the progress of a multimillion-dollar clinical drug trial. But adaptive design trials are changing that. |
The Motley Fool March 29, 2010 Brian Orelli |
Look for Companies That Strike First Head-to-head trials, whether they're run by companies or by third parties, can be scary. But the way to make big money is by selling drugs that offer superior benefits, so investors should welcome the onslaught of upcoming comparative trial data. |
The Motley Fool January 3, 2011 Brian Orelli |
Clinical Trial Results Fail to Inspire Inspire Pharma gets cut in half after a cystic fibrosis trial failure. |
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 August 18, 2004 Mark D. Uehling |
I, Virtual Patient Along with a software company specializing in modeling diseases on the computer, Roche Diagnostics is working on creating a new biomarker for diabetes that could be reduced to a simple blood test. |
Pharmaceutical Executive July 1, 2006 Derek Lowe |
What You Need to Know About Adaptive Trials A handful of new statistical techniques and clinical-trial designs will let you change the way you run your business. Here's your guide to the basics. |
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? |
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? |
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 February 2007 Kevin Davies |
Ten Years After: Learn and Confirm Wyeth faces the same problems bedeviling the industry: the soaring cost of development is matched only by the rising attrition rate as once promising drug candidates fall by the wayside. But a new strategy leads to a more science-driven model. |
The Motley Fool February 12, 2010 Brian Orelli |
Don't Ignore This Potential Blockbuster Five trials later, Roche's diabetes drug taspoglutide seems like a winner. |
Bio-IT World August 2005 John Russell |
Pfizer's Model of Success Pfizer Global Research & Development began using sophisticated modeling technology and collaboration software to speed its race to a go-no-go decision on a cholesterol-lowering drug project. Killing the project sooner saved up to $2.8 million in costs and six months in delay. |
Bio-IT World April 2006 Kevin Davies |
Putting the IT in Clinical Trials A new report says that the clinical trials process must be reinvented to reverse the output decline of the pharmaceutical industry and meet the needs of its patients. That reinvention will be shaped by major advances in information technology. |
The Motley Fool August 27, 2010 Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. |
The Motley Fool December 29, 2006 Brian Lawler |
Is Threshold on the Verge of Success? Shares of Threshold Pharmaceuticals were the second-best performer on the market yesterday, up 28% as a result of positive phase 2 clinical trial results for its lead drug, glufosfamide. |
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. |
The Motley Fool March 4, 2011 Brian Orelli |
Pfizer's Biggest Shot at Lipitor 2.0 It might need a little help from competitors. |
Bio-IT World May 9, 2003 Mark D. Uehling |
Data Rapture? Electronic capture of data: Some say it unclogs the medieval clinical trials process. Others remain skeptical of software and put their trust in paper. |
Chemistry World April 2006 Karen Harries-Rees |
Editorial: Drugs Testing on Trial A drugs trial in the UK that went disastrously wrong last month has raised questions about the ethics of using paid volunteers in clinical trials and the usefulness of animal testing. |
The Motley Fool March 1, 2007 Brian Lawler |
Know Your Drug Stock ABCs: Part 2 Investing in the pharmaceutical and biotechnology industries can be difficult. Here are terms investors should know to better understand how the clinical trial process involved with bringing a drug to market works. |
The Motley Fool May 17, 2010 Luke Timmerman |
Vertex Awaits Final Proof that Hepatitis C Drug Works For this drug researcher, the proof is in the telaprevir. |
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. |
Pharmaceutical Executive September 1, 2005 Mattingly & Saxberg |
Biomarkers Come of Age In the past five years, biomarkers have become an essential part of pharmaceutical R&D. Seven industry experts explain how it happened - and what comes next. |
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. |
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. |
The Motley Fool June 18, 2010 Brian Orelli |
Hot Dog! No Competition for Now Roche's diabetes pipeline drug is delayed. |
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 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 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. |
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. |
Pharmaceutical Executive October 1, 2005 Lisa Grimes |
Clear Road Ahead An industry standard for publicizing clinical-trial results is a ways off. But pharma's openness to more transparent procedures is moving things in the right direction. |
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 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. |
The Motley Fool March 16, 2011 Brian Orelli |
Different Name, Same Great Results Incyte and Novartis' ruxolitinib passes another clinical trial. |
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 August 18, 2004 Anthony Strattner |
Opportunity to Gain or Lose A keynote speaker at Best Practices ceremony asserts that drug-development science -- those activities that go beyond translational science and into product testing and commercialization -- has stagnated, causing a pipeline problem. |
Pharmaceutical Executive June 9, 2014 Getz et al. |
Adaptive Trial Design: Prepping for Adoption Biopharmaceutical companies are targeting improvements in clinical trial design as a critical factor in pipeline portfolio success. |
Chemistry World October 15, 2013 Dinsa Sachan |
Supreme court ruling brings clinical trials to a halt in India The fate of 162 global clinical trials hangs in the balance, as the top Indian court has asked the government to provide more details on their approval process before they can proceed. |
Bio-IT World March 2007 John Russell |
In Search of Spring Tired of winter? Here are some signs of spring for systems biology acceptance and a preview of Cambridge Healthtech's June conference, Applying Systems Biology, to whet your appetite for summer: 1. FDA Survey... etc. |
Bio-IT World June 17, 2004 John Russell |
Systems Biology - Now Leaving on Track 1 Entelos, a leader in predictive biosimulation, partners with pharmaceutical and biotech organizations worldwide to develop effective new treatments for disease. Michael French, chief business officer at Entelos, explains what powers the systems biology engine. |
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 August 2005 Ellen H. Julian |
Tech Expertise Singles Out Outsourcers Biopharmaceutical companies are flocking to consultants, outsourcers, and staffing firms to help with discrete clinical trial processes to gain access to advanced technologies and reduce the drain on already-scarce IT resources. |
The Motley Fool December 27, 2010 Brian Orelli |
Painful Clinical Hold? Not Really. Regeneron offers the benefits of a full pipeline. |
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. |
BusinessWeek February 25, 2010 Weintraub & Tirrell |
Eli Lilly's Drug Assembly Line Faced with expiring patents that could weaken sales, Lilly is reorganizing for speed. |
CIO October 15, 2001 Stephanie Overby |
Drug Companies on speed The marriage of IT and medical research may be just what traditional pharmaceutical companies need to survive in an increasingly competitive field. Learn how IT is bringing the pharmaceutical industry into the information age... |
The Motley Fool September 27, 2010 Brian Orelli |
Better Buy: Ariad Pharmaceuticals or Corcept Therapeutics? A battle of drugless companies looking for their first hit. |
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. |