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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.
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.
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.
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 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 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 3, 2011 Brian Orelli	Clinical Trial Results Fail to Inspire Inspire Pharma gets cut in half after a cystic fibrosis trial failure.
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 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.
Pharmaceutical Executive September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
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 March 8, 2010 Brian Orelli	Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting.
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.
The Motley Fool March 30, 2010 Brian Orelli	FDA Lags, Investors Flee Cephalon gets no love from the FDA. The agency failed to expand Cephalon's Nuvigil for the treatment of jet lag.
The Motley Fool August 9, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
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 December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
Pharmaceutical Executive November 1, 2008 Jill Wechsler	Resolving Conflicting Interests The Physician Payment Sunshine Act would require pharmaceutical and medical device companies to disclose payments of more than $500 to doctors.
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 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.
Bio-IT World August 13, 2003 John Rhodes	Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert.
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.
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, 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 9, 2007 Brian Lawler	Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note.
Bio-IT World April 2006 John Russell	Lobbying for Critical Path Funding The FDA's Critical Path Initiative is an important program in need of cold hard cash and dedicated FDA personnel.
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
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 February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
Bio-IT World September 2005 Mark D. Uehling	Murky Diary Entries The FDA is planning to clarify the degree to which existing patient diary technologies are (or are not) encroaching on data-management duties formally assigned to clinical investigators. That guidance is in the works, with no known timetable.
Bio-IT World March 10, 2003 Spink & Blumenstiel	Getting IT Right Applying information technology to trials can boost productivity. Here's a strategic framework for going e-clinical.
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.
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.
Pharmaceutical Executive June 1, 2014 Jill Wechsler	Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.
The Motley Fool March 15, 2010 Brian Orelli	FDA Says "No Way!" Market Says "Yeah, Baby!" You can have it both ways. The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals, Eli Lilly, and Alkermes were looking for, but they'll take it.
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 April 16, 2004	Best of the Best, Sir The FDA wants to change its ways and share its accumulated wisdom as part of a focused attack on costly, unpredictable product development.
Bio-IT World November 19, 2004 Mark D. Uehling	Safety Last? Antiquated reporting of adverse events in clinical trials is costing pharma billions and forcing it to seek new pharmacovigilance solutions.
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.
The Motley Fool January 20, 2011 Brian Orelli	This Stock Is No Dreamboat The FDA is not kind to MannKind.
The Motley Fool May 3, 2007 Mike Havrilla	Heads Up, Biotech Investors: Chapter 3 Time your stocks, not the market. Savient... VISICU... VIVUS... Cortex...
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 August 20, 2011 Luke Timmerman	Seattle Genetics Wins FDA Approval of First Drug FDA gives a quick turnaround on the new treatment for lymphomas.
The Motley Fool January 14, 2005 W.D. Crotty	An FDA OK That Hurts EPIX Pharmaceuticals gets a qualified "yes" from the FDA, sending its stock tumbling.
Bio-IT World September 16, 2004 Paul King	Growing Gains When it comes to information technology requirements, the biotech industry is unlike any other. A key enabler of efficient and effective growth is the adoption of IT strategies specific to each of four key stages.
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 June 12, 2006 Catherine Arnst	Going From The Lab To Limbo The FDA has been delaying decisions on applications, and drugmakers are fuming.
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.
Reason Aug/Sep 2007 Kerry Howley	Dying for Lifesaving Drugs Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments?