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Bio-IT World June 2005 Judy Hanover	Drug Safety - Issues & Opportunities Information technology, specifically safety databases and concomitant data-mining efforts, holds great promise for providing a potential solution to daunting drug safety problems, despite lingering uncertainty.
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 May 1, 2006 Madison, Chan & Seeger	Making the Link The FDA recognizes that a new drug standard must evolve -- one of routine, proactive safety surveillance. But post-marketing safety studies are too slow. Here's how pharmaceuticals are using claims databases to solve the problem.
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.
Pharmaceutical Executive November 1, 2006	Unraveling the eSource Industry-wide standards for electronic patient data have long felt like buried treasure. Companies today are getting closer - by way of a tangled map.
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.
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.
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.
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 March 10, 2003 Kenneth Getz	E-Clinical Technology Overview Clinical trial researchers want to leverage the benefits of IT -- and now they can for every core process. But they also have to get past the barriers to adoption.
Pharmaceutical Executive September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
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 July 2005 Mark D. Uehling	'E-source' Is Coming, Experts Say The odd marriages of the ancient and modern in clinical technologies were in evidence at the E-Clinical Trials & Research conference program. There was evidence of the adoption of advanced and robust commercial software -- even toward clinical trials that do not use paper, though most do.
BusinessWeek December 13, 2004 John Carey	How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs.
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.
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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap 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.
Bio-IT World December 15, 2004 Kevin Davies	Patients Before Profits? After the Vioxx disaster, Pharma needs to reassure patients that they come first.
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.
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.
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.
Bio-IT World February 2007 Beth Harper	Meshing EDC with CTMS Many unsolved problems in conducting clinical trials cause delays, wasted resources, team frustration, and even safety issues. Thus, the industry is turning more of its attention away from Electronic Data Capture to Clinical Trial Management Systems.
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.
Bio-IT World June 2005 Mark D. Uehling	Abandon Paper! Use a PDA! The entire pharmaceutical industry is migrating away from paper diaries, fraught as they are with patients' well-meaning but well-documented procrastinations and fabrications. But electronic gadgets are not inexpensive, even for rich sponsors of clinical trials.
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.
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 17, 2010 Brian Orelli	Thanks for Nothing, Fen-Phen Arena gets knocked down despite a relatively clean side-effect profile.
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 December 12, 2007 Brian Orelli	What's Merck Doing? With a nice solid pipeline Merck is on its way to its goal of double-digit EPS growth through 2010.
Bio-IT World March 2006 Salvatore Salamone	Pfizer Digs Deeper in Mining Trial Data Besides using the information mined from past trials to help design new studies, examine new uses for a drug, or study ways to minimize risks, the data-mining efforts are also being applied to looking at how drugs on the market are being used.
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.
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?
Searcher June 2012 Stephanie C. Ardito	The Medical Digital: How Safe Are the Prescription Drugs we Take? Monitoring Adverse Events and Recalls For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations.
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.
The Motley Fool February 23, 2005 Stephen D. Simpson	Take Two on COX-2 FDA panel recommendations breathe new life into Merck and Pfizer's COX-2 pain medications. Looking ahead, investors should give a good, long look to the drug sector.
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 January 3, 2011 Brian Orelli	Clinical Trial Results Fail to Inspire Inspire Pharma gets cut in half after a cystic fibrosis trial failure.
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.
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.
Pharmaceutical Executive April 1, 2012 Jill Wechsler	Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors.
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
The Motley Fool September 8, 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.
Pharmaceutical Executive January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
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.
Bio-IT World March 2006 Mark D. Uehling	Oracle Discusses Agenda for Clinical Trials In surprising ways, Fusion is helping to shape Oracle's strategy in the clinical trial space.
The Motley Fool February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
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.