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The Motley Fool June 13, 2007 Brian Lawler |
Neurochem Collects the Data Neurochem hints at the data for its Alzheimer's disease drug candidate. The FDA doesn't like data that is hard to interpret, nor is it a fan of retrospective analyses. Investors, take note.  |
The Motley Fool December 10, 2007 Brian Lawler |
Neurochem's Sure Bet at Failure Investors should add another regulatory date to their biotech calendars, this one regarding Neurochem's lead drug, KIACTA.  |
The Motley Fool July 18, 2007 Brian Lawler |
More Misery for Neurochem It's hard to find another drug developer that has mishandled its correspondence with investors about its drug candidates as badly as Neurochem has over the past year.  |
The Motley Fool April 17, 2007 Brian Lawler |
Neurochem Must Wait The FDA delays a regulatory decision on Neurochem's lead compound. Investors, take note.  |
The Motley Fool April 2, 2008 Brian Lawler |
Following the Drugmaker Formerly Known as Neurochem Neurochem would have been set to hear FDA news on its lead drug candidate Kiacta today, if they had not pulled their marketing application earlier this month.  |
The Motley Fool June 25, 2007 Brian Lawler |
Neurochem Hems and Haws Neurochem delays the announcement of clinical trial results from its lead drug to treat Alzheimer's disease. Investors would be smart to stay far, far away.  |
The Motley Fool December 18, 2007 Brian Lawler |
The Final Nail in Neurochem's Coffin The European Medicines Agency announced its refusal to approve Neurochem's lead drug, KIACTA.  |
The Motley Fool August 27, 2007 Brian Lawler |
Neurochem Down for the Count? With likely two failed compounds - since the FDA rejected Neurochem's amyloidosis compound Kiacta a second time in July -- it's hard to see much value in shares of the company, considering its bare drug pipeline.  |
The Motley Fool November 14, 2007 Brian Lawler |
Neurochem's Crazy Choice Neurochem chooses a risky path for its lead drug candidate, attempting to have its Alzheimer's disease medication marketed as a dietary supplement.  |
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 December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.  |
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 9, 2007 Brian Lawler |
Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note.  |
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 August 28, 2006 Brian Lawler |
The Commandments of Biotech Investing Since long-term successful biotech investing requires accurate risk assessment, you must be aware of the risk you're taking on. Just as with any prospective investment, if you diversify your biotech holdings, you can somewhat mitigate these various risks.  |
The Motley Fool January 31, 2008 Brian Lawler |
When Nutraceuticals Attack After a failed phase 3 trial, Neurochem plans to market Alzhemed as a nutraceutical supplement.  |
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 November 27, 2006 Brian Lawler |
Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump.  |
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 September 13, 2007 Brian Orelli |
Alfacell's Awkward Wait Waiting for subjects to die is a somber part of the oncology clinical trial process. Alfacell is doing just that in its final phase three trial with its lead cancer drug candidate. Investors take note.  |
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 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 August 9, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.  |
The Motley Fool May 1, 2007 Mike Havrilla |
Heads Up, Biotech Investors Big news is in the offing for these companies. Pozen... Progenics... Zymogenetics... etc.  |
The Motley Fool September 8, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.  |
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 February 1, 2011 Brian Orelli |
Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.  |
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 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 April 8, 2011 Brian Orelli |
A Shutdown of Binary Events? A government shutdown will likely stop FDA approvals.  |
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 October 16, 2007 Brian Orelli |
Pozen Hedges Its Bets As promised, Pozen and partner GlaxoSmithKline announce that the pair have submitted a response to their approvable letter for Trexima, and that they plan to do an additional just-in-case safety trial.  |
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.  |
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 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 May 18, 2009 Brian Orelli |
Is There Life After 600% Returns? Just because a drug company gets a massive increase in the stock price after a positive clinical trial or an FDA approval, that doesn't mean all the growth is completely factored into the stock price.  |
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.  |
The Motley Fool June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.  |
The Motley Fool May 4, 2011 Brian Orelli |
Cell Therapeutics: Denied but Not Rejected Cell Therapeutics' ball may be headed for the end zone, but the FDA has an eight-foot free safety ready to bat it down.  |
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 27, 2011 Arundhati Parmar |
St. Jude Medical's Migraine Treatment: Good for Europe, but Not the U.S.? St. Jude won't comment on whether the company plans to do a second clinical trial or whether it is confident it will win approval from the FDA without it.  |
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.  |
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.  |
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.  |
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 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.  |
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.  |
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 November 2006 Mark D. Uehling |
Putting EDC on the Fast Track There's no escaping the imposing numbers of choices in launching a clinical trial using electronic data capture. Is there a better way? Clinical trial consultant Fast Track Systems says it has one.  |