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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. |
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 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. |
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? |
Pharmaceutical Executive July 1, 2012 William Looney |
Today's Mission Critical: Making Sense of Spending on Clinical Trials Mastery of the clinical trial process has become essential to positioning new therapies for leadership in an increasingly crowded and lengthy race to registration. |
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. |
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. |
Pharmaceutical Executive December 1, 2010 Walter Armstrong |
Alzheimer's: A Disease at a Crossroads The need for new drugs intensifies as more and more Baby Boomers live into advanced old age. The global market is estimated to be worth $20 billion by the end of the decade. |
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 May 17, 2010 Luke Timmerman |
Vertex Awaits Final Proof that Hepatitis C Drug Works For this drug researcher, the proof is in the telaprevir. |
Reason Aug/Sep 2007 Kerry Howley |
Dying for Lifesaving Drugs Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments? |
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. |
BusinessWeek February 6, 2006 Amy Barrett |
Cracking The Whip At Wyeth Wyeth's R&D chief Robert Ruffolo imposed tough targets on scientists - and it's working. |
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. |
Chemistry World September 2007 Derek Lowe |
Column: In the Pipeline Will Phase Zero trials actually help drug development? |
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 March 2006 Kevin Davies |
Clinical Data Launches Landmark Trial Clinical Data has launched a Phase III clinical trial for the depression drug vilazodone and will concurrently develop a diagnostic test. The study could prove to be a landmark event in pharmacogenomic medicine. |
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 March 3, 2010 Brian Orelli |
A Costly Missed Connection Dimebon's phase 3 failure costs Medivation shareholders 67%. |
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 December 1, 2010 Walter Armstrong |
The Next Wave: Pharm Exec's 2011 Pipeline Report 42 of the best new drugs in development or parked at the FDA |
Chemistry World November 2010 |
Column: In the Pipeline Should drug companies focus on big markets and the blockbuster dream? |
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 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. |
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 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 December 27, 2010 Brian Orelli |
Painful Clinical Hold? Not Really. Regeneron offers the benefits of a full pipeline. |
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. |
Pharmaceutical Executive August 1, 2013 William Looney |
Breaching the Great Wall With a revision of China's basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation. |
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. |
Pharmaceutical Executive June 1, 2012 |
2012 Dealmakers Outlook With Yankee Stadium as the backdrop, Pharm Exec convened on its annual panel of heavy hitters in business development to crack the bat on best practices in licensing and for the year ahead. |
The Motley Fool June 18, 2008 Brian Lawler |
Elan's and Wyeth's Data: Success or Failure? Elan and partner Wyeth released new mid-stage data for their potential blockbuster bapineuzumab (AAB-001) for Alzheimer's disease, but the results aren't conclusive. |
The Motley Fool May 19, 2010 Brian Orelli |
The Biggest-Little Biotechs in the World If you do decide to invest in these biotechs before they've secured phase 3 results make sure you know what you're getting yourself into and aren't blindly following the crowd. |
Pharmaceutical Executive October 1, 2008 RS Kumar |
Evolving Clinical Trials Clinical trials need to change. A recent survey shows that industry should address the research supply chain for the greatest gains in efficiency. |
Wired March 2006 Jennifer Kahn |
A Nation of Guinea Pigs There's a new outsourcing boom in South Asia - and a billion people are jockeying for the jobs. How India became the global hot spot for drug trials. |
Pharmaceutical Executive November 1, 2013 |
Roundtable on Market Access Market Access is a window on what matters in the real world of soaring patient expectations and crimped payer budgets for innovation. |
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 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. |
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. |
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 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. |
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. |
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 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. |
The Motley Fool August 9, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area. |
Chemistry World January 25, 2013 Rajesh Parishwad |
Indian supreme court's anger over unregulated clinical trials The fledgling clinical trials industry in India has been hit by recent revelations of a lack of regulation. Now, the country's supreme court has criticized the body that oversees clinical trials for its inaction in the face of these unethical practices. |
The Motley Fool July 1, 2011 Alex Crawford |
3 Biotech Drugs With Promising Phase III Data, Moving Into FDA Review Do these drugs have a chance of FDA approval? |
Bio-IT World October 2006 William Claypool |
The Perfect Circle With the most current technologies accelerating adaptive trial designs, the future holds great promise. |
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 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. |