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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. |
Pharmaceutical Executive December 1, 2011 Lujing Wang |
The Payoff for Payers Thorough risk assessment is essential before placing bets on good evidence that clears a path to approval. |
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 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. |
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 July 8, 2008 Brian Lawler |
Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards. |
Chemistry World September 2009 |
Column: In the pipeline What's the most difficult therapeutic area for drug discovery? They're certainly not all created equal - or if they were, they have definitely diverged since then. The question can be narrowed down quite a bit. |
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. |
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? |
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. |
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. |
The Motley Fool June 29, 2007 Brian Orelli |
The Phase 2 Blues Drug developer Cytokinetics disappoints investors with failed clinical trials. |
The Motley Fool March 21, 2007 Brian Lawler |
New Indication for Pain Pain Therapeutics brings a new drug into the clinic. When drug companies attempt to bring new drugs that are outside of their core competencies to market, investors always need to be wary. |
Chemistry World June 22, 2011 Sarah Houlton |
US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe. |
Pharmaceutical Executive December 1, 2012 William Looney |
The Puzzle Master: Dr. Guido Rasi Europe's chief regulator charts a strategy from many moving parts. |
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 October 1, 2008 Joanna Breitstein |
The D-Mab Men Amgen's salvation just may be denosumab. We sit down to talk with the head scientists driving the drug for the multi-billion dollar osteoporosis market |
AskMen.com Joshua Levine |
Selling Your Body To Science Have you ever thought about the number of voluntary patients who basically sell their bodies to clinical trials in the name of science? Well, the number is staggering and it can reach well into the thousands. The main reason being the large paycheck that comes with the job. |
Pharmaceutical Executive April 1, 2012 Feam & Lagus |
Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help. |
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. |
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 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 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 June 1, 2006 Nancy Dreyer |
Personalized Medicine Meets the Real World A wave of genomic medicines is coming down the pipeline, and they're going to be expensive. Can companies prove they're worth it? Maybe: but the claims payers seek aren't coming from traditional clinical trials. |
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 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 February 1, 2006 Ron Feemster |
Gene Logic: Rescue Squad One or two late-stage clinical failures can land promising drug candidates on the shelf. Forever? Maybe not. Gene Logic tests Big Pharma's dead drugs for hundreds of different targets. |
Pharmaceutical Executive August 1, 2012 Carol Ann Williams |
Data Exclusivity: Making the Case As the scope and complexity of registration information demanded by regulators increases, protection of that know-how has become a critical differentiator in the "go" or "no go" calculation on whether to invest in a new medicine. |
Pharmaceutical Executive January 1, 2012 William Looney |
Pharma 2012: Hard Times Before the Harvest 2012 will be a transition year for pharma, one of the most important in its history. The challenge is that many new treatments may not complete the move from 'bench to bedside' in time to plug the yawning revenue gap. |
The Motley Fool October 9, 2006 Brian Lawler |
The Commandments of Biotech Investing, Part 2 It's a complex field, but it's not impossible for investors to master. The more in-depth your research of a potential biotech investment, and the more you remember to follow these commandments, the better your potential for success will be when investing in this fascinating field. |
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. |
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. |
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? |
Pharmaceutical Executive January 1, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
Reason October 2007 Ronald Bailey |
Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest." |
The Motley Fool January 21, 2010 Brian Orelli |
Here's That Critical Merck Info You Missed Announcing clinical trial failures in a FAQ? Really? |
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 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. |
Chemistry World April 2006 Karen Harries-Rees |
Editorial: Drugs Testing on Trial A drugs trial in the UK that went disastrously wrong last month has raised questions about the ethics of using paid volunteers in clinical trials and the usefulness of animal testing. |
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. |
Pharmaceutical Executive March 1, 2013 Ken Getz |
Building Clinical Trial Awareness for Patients: Why Not Try the Pharmacist? The author explains how building a stakeholder outreach agenda around the community pharmacist can lead to a better outcome in managing the complex ins and outs of a trial protocol. |
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. |
Pharmaceutical Executive September 1, 2014 William Looney |
Ireland's Celtic Tiger: Back on the Hunt Leaders from industry, government, and the CRO community examine Ireland's future as a magnet for life science investments, and what the nation must do to remain the leading exporter of finished pharmaceutical products. |
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 September 1, 2013 Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
Pharmaceutical Executive November 1, 2011 Elizabeth O. Coulton |
Clinical Trial Issues Not Just Black and White The selection of clinical trial participants must meld with the changing demographics of America if industry is to improve medicines that work for patients. |
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 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. |
Chemistry World August 23, 2012 Simon Campbell |
Protecting patients at all costs A new funding model is urgently required to deliver innovative medicines that meet the medical needs of the 21st century and contribute to economic growth. |