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Fast Company December 2009 Erica Westly |
The Price of Winning FDA Approval Approval for a new drug or medical treatment requires extensive -- and expensive -- human trials for safety and effectiveness. |
Chemistry World December 5, 2014 Rebecca Trager |
Tufts' $2.6bn drug development figure questioned Recent data indicating that it costs about $2.6 billion to develop and win market approval for a new prescription drug in the US has come under scrutiny. |
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 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. |
Bio-IT World July 11, 2002 Kevin Davies |
Counting the Cost of Drug Discovery Much of the trouble ensnaring the drug industry is blamed on the exorbitant cost of drug discovery. Tangible proof that the bio-IT revolution will economize drug discovery is emerging, but there is still a long way to go. |
Chemistry World May 8, 2008 Hepeng Jia |
China to fast track pioneering drugs China is to speed up the approval of groundbreaking new drugs in an effort to encourage innovation in its pharmaceutical sector, a State Food and Drug Administration (SFDA) official has revealed. |
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. |
Information Today July 2, 2013 |
Thomson Reuters Offers Clinical Trial Intelligence Solutions These solutions improve clinical trials, speed up product development and release, and help professionals strengthen portfolios and R&D strategy. |
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. |
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. |
The Motley Fool June 19, 2009 Brian Orelli |
Comparative Medicine Could Sink Your Stocks The government's plan will have a very unpredictable effect on companies. |
The Motley Fool December 11, 2006 Michael P. Cecil |
Why Doesn't Buffett Buy Drug Companies? Investors, how do you estimate the amount of money that a drug company, or perhaps more simply one of its drugs, will produce over its lifetime? |
The Motley Fool July 6, 2004 Brian Gorman |
Hidden Drug Costs Regulatory requirements play an important role in drug expenses. |
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 January 26, 2005 Stephen D. Simpson |
The Pipeline to Biotech Success Looking at drug R&D is the best way to begin assessing biotech companies as possible investment opportunities. |
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 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. |
Managed Care July 2006 |
Public Payers Foot Greater Pharmacy Costs Through 2005, private health insurance had covered most of the cost of prescription drugs. That picture is changing as public payments, mostly under Part D, are projected to exceed private health insurance and out-of-pocket payments. |
Chemistry World December 8, 2006 |
Expert Guidance on Clinical Trial Safety Clinical trial design in the UK is due for a shake up following the recommendations of an expert group commissioned in light of a disastrous trial that left six subjects fighting for their lives. |
The Motley Fool July 17, 2007 Brian Orelli |
An Investor's Guide to the New PDUFA It's important for investors in drug companies to keep up with the latest clinical trial news, but policy changes in Washington can affect companies' bottom lines just as much. |
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 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 30, 2007 Brian Orelli |
Clinical Trial Failures Don't Bother These Companies Contract research organizations, outsourcing companies hired by pharmaceutical and biotech companies to run pre-clinical tests and clinical trials for them, succeed even when drugs fail, and more work may be coming their way. |
Bio-IT World Dec 2006/Jan 2007 Mark D. Uehling |
Vertex Views Trial Supplies For a recent clinical trail, the head of clinical development systems at Vertex Pharmaceuticals found a new software offering from Tourtellotte Solutions. |
Pharmaceutical Executive November 1, 2013 Jill Wechsler |
Transparency Troubles for Pharma High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise. |
Chemistry World July 2008 William Bains |
Beyond shareholder returns The author offers a new model for the pharmaceutical industry |
Chemistry World November 12, 2013 Dinsa Sachan |
Rough patch for India's clinical trial industry The Indian clinical trial industry is beset by uncertainty. Campaigners have petitioned the courts claiming that drug companies are exploiting poor people and this has led to more than 100 trials being put on hold. |
Bio-IT World January 21, 2005 |
How IT Can Decrease Time-to-Market in Clinical Trials Pharma manufacturers can learn from their industrial counterparts: Integrating systems can accelerate product delivery. |
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 October 10, 2005 Stephen D. Simpson |
The FDA: Boon, Bane, Whipping Boy Everyone wants the FDA to be faster, better, and cheaper, but that may not be a credible expectation. Investors would do well to keep an eye on the FDA because its policies and pressures ultimately filter down to our medicine cabinets, wallets, and portfolios. |
Chemistry World May 27, 2015 Phillip Broadwith |
Label laundry It's been an interesting month in the world of off-label pharmaceuticals. |
Bio-IT World July 14, 2004 |
The True Cost of Drug Discovery A new book with the provocative title "The $800 Million Pill" threatens to "strip away pharmaceutical industry spin" about the true cost of drug development. |
Managed Care September 2004 Thomas Morrow |
Orphan Drug Act Treatments Deserve Full Insurance Coverage An important federal law encourages development of drugs for populations so small that the market would otherwise ignore them. Should they not then be covered? |
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. |
The Motley Fool September 12, 2005 M.D. Mitchell |
Big Problems for Big Pharma Creating new drugs is never easy, but the companies that excel in three key areas are the ones for investors to watch. |
The Motley Fool September 8, 2004 Charly Travers |
Will a Clinical Trial Database Help Investors? While this development is certainly good news for patients and physicians, the impact on investors may be minimal, depending upon the type of data that will be released. |
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. |
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. |
Managed Care August 2000 |
With Cost Study, Group Argues For OTC Benefit A study by HECON Associates, a Maryland-based market research group, supports the claim that when prescription drugs become available over the counter, consumers face increased out-of-pocket costs. |
The Motley Fool September 9, 2004 Charly Travers |
The Case for Drug Stocks The reports of the drug industry's death are greatly exaggerated. |
Pharmaceutical Executive June 1, 2006 Sarah Houlton |
Global Report: People Problems A recent clinical trials disaster is causing UK regulators to consider revising its guidelines for Phase I human studies for biologics. However, in many cases, potential solutions present additional problems. |
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. |
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? |
The Motley Fool September 7, 2007 Brian Orelli |
Clinical Data Gets Personal Clinical Data's lead compound Vilazodone posts strong phase 3 results. The company is searching for common genetic markers among patients who responded positively to the drug. |
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 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. |
Chemistry World May 8, 2013 Phillip Broadwith |
Clinical trial data release blocked by companies Two pharmaceutical companies have been granted injunctions to prevent the European Medicines Agency from releasing clinical trial data about their drugs. |
Chemistry World October 8, 2010 Sarah Houlton |
U-turn on Alzheimer's drugs in the UK The UK National Institute for Health and Clinical Excellence proposes that those with mild disease will be able to receive them from early next year, on the basis of growing clinical evidence of their effectiveness. |
AskMen.com Richard Stevens |
Participating In Clinical Trials Check out what participating in clinical trials involves and how you can join a study. You may even make some cash in the process. |
Managed Care July 2005 Martin Sipkoff |
Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules. |