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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?   |
Bio-IT World
Jul/Aug 2006
John Russell |
Pharsight CRADA to Assist FDA with Modeling Initiative Pharsight will use FDA's feedback to further develop their server to meet drug-maker's analysis requirements, and further develop their visualization and collaboration tool to support FDA-sponsor interactions for the visualization and communication of model-based product profiles. |
Pharmaceutical Executive
February 1, 2011
Jill Wechsler |
The Building Block of Drug Discovery With Francis Collins now calling the shots at NIH, will be be able to deliver on the innovations behind the genome? |
Chemistry World
July 2010
Anna Lewcock |
Medicine made to measure Healthcare tailored to suit the genetic makeup of the patient is finally coming to fruition. |
Pharmaceutical Executive
September 1, 2005
Mattingly & Saxberg |
Biomarkers Come of Age In the past five years, biomarkers have become an essential part of pharmaceutical R&D. Seven industry experts explain how it happened - and what comes next. |
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 |
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
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
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
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. |
Pharmaceutical Executive
July 1, 2011
Dickmeyer & Rosenbeck |
From Rut to Racetrack Can the pharmaceutical industry deliver on its objective to make cancer a curable, chronic condition? |
Pharmaceutical Executive
February 1, 2013
William Looney |
Pathways to Progress Cancer is increasingly understood as a collection of rare and mostly treatable conditions rather than the impregnable, monolith portrayed in popular culture. Industry experts review current and pending efforts to turn great science into good practice. |
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. |
BusinessWeek
August 26, 2010
Tom Randall |
Cocktails Are Next For Cancer-Drug Makers Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer. |
Bio-IT World
Dec 2006/Jan 2007 |
Resolute in the New Year Industry leaders in areas from pharmacogenetics to cheminformatics found 2006 to be a year of important steps forward, but looked with even more anticipation to 2007: Allen D. Roses, SVP, Pharmacogenetics GlaxoSmithKline... etc. |
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. |
Bio-IT World
March 8, 2005
Patricia Reilly |
Biomarkers: Trends and Potential Companies are centralizing biomarker research to help reduce spending. |
The Motley Fool
July 27, 2010
Jim Mueller |
3 Stocks to Play Biotech Here are three promising ideas for this exciting area. |
Bio-IT World
August 18, 2004
Anthony Strattner |
Opportunity to Gain or Lose A keynote speaker at Best Practices ceremony asserts that drug-development science -- those activities that go beyond translational science and into product testing and commercialization -- has stagnated, causing a pipeline problem. |
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. |
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
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
August 9, 2010
Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area. |
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. |
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. |
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
April 25, 2011
Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it? |
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
May 1, 2006
Jill Wechsler |
Washington Report: Opportunity Knocks FDA has finally released its long-awaited list of research opportunities for the Critical Path initiative. Now comes the hard part, as companies learn how to collaborate on projects that will benefit pharma as a whole. |
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. |
Pharmaceutical Executive
July 1, 2012
Jill Wechsler |
Who Will Pay for New Drugs? Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies. |
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. |
Bio-IT World
Jul/Aug 2006
Eric K. Neumann |
Combining Drug Toxicity Knowledge Nearly half the drugs entering clinical trials will fail because of some form of serious toxicity that was missed in preclinical studies. These failures should not happen at such a late stage in the process. So what can be done? |
Pharmaceutical Executive
December 1, 2011
Ben Comer |
Pharm Exec's 2012 Pipeline Report It's a neck and neck race toward safer, faster, and medically superior treatments. Which organizations have what it takes to jockey their products into the winner's circle? |
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
September 8, 2010
Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area. |
Pharmaceutical Executive
March 1, 2011
Jill Wechsler |
New Tools Track Safety, Value in Medicine FDA's Sentinel Initiative raises broader questions about tapping patient information and health IT for comparative studies in drug development. |
The Motley Fool
August 27, 2010
Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. |
Pharmaceutical Executive
December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. |
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. |
Wired
August 24, 2009
Steve Silberman |
Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why. The fact that taking a faux drug can powerfully improve some people's health -- the so-called placebo effect -- has long been considered an embarrassment to the serious practice of pharmacology. |
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. |
Bio-IT World
September 2006
Kevin Davies |
The $2 Billion Pill? Challenges and opportunities facing the drug industry were recurring themes in the quartet of keynote speeches at the 2006 Drug Discovery Technology conference. |
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. |
Pharmaceutical Executive
September 1, 2013
Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
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. |
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. |
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
January 1, 2011 |
The San Diego Story San DIego works as a locus for risky investments in the big ideas that lead to biotech breakthroughs |
