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NEWS FEATURE: Networking for new drugs

NEWS FEATURE: Networking for new drugs

By Claire Ainsworth At first sight, it seems like a rather perplexing experiment. In several hospitals across France, some 60 patients are taking part in a clinical trial to test a combination of three drugs. The first striking thing about this trial is that the drugs have already been approved for human use. The second is that each drug is being given at doses between 10 and 100 times weaker than those usually prescribed. Finally, and most surprising of all, none of the patients suffer from the conditions for which these drugs were originally developed. They all have Charcot-Marie-Tooth disease  … Read more

Cancer drugs find a companion with new diagnostic tests

By Charlotte Schubert When Stephen Little co-founded a molecular diagnostics company in 2001, he gave numerous presentations to pharmaceutical companies touting the benefits of tests that can tell which patients are likely to respond to a particular therapy or experience side effects. But most drugmakers were focused on blockbusters, and, since these so-called ‘companion diagnostics’ divide patient populations into smaller groups, they threatened to contract, not expand, their markets. As such, Little recalls, “there was not a great deal of enthusiasm.” Ten years later, the tide has changed for Little and the field of companion diagnostics. In 2009, Little’s company,  … Read more

OPINION: The NIH translational research center might trade public risk for private reward

By Jerry Avorn and Aaron S. Kesselheim As the US National Institutes of Health faces a $300 million budget reduction, it is creating a unit to facilitate the development of new drugs. The National Center for Advancing Translational Sciences (NCATS) envisioned by NIH Director Francis Collins would redeploy resources from the agency’s existing programs to identify discoveries that could be transformed into therapeutic products. The road that brings treatments from bench to bedside is notoriously bumpy, and recent years have seen a scarcity of transformative medications and novel drug designs. Of the 47 new products approved in 2009–2010, by our  … Read more

EDITORIAL: Drug targets slip-sliding away

Papers trumpeting new drug targets are a staple of biomedical journals such as Nature Medicine, but their claims are viewed skeptically by many drug development professionals. This skepticism has only been reinforced by a recent attempt to put some numbers on the reproducibility of such reports in a real-world setting (Nat. Rev. Drug Discov. 10, 712, 2011). The authors, from Bayer Healthcare, surveyed their in-house scientists tasked with experimentally validating publications on new drug targets. For only 21% of the 67 cases examined did they find results considered to be completely in line with the literature.  Read more

Patent protection brings hope to insurers

By Georgina Kenyon Insurance companies are stepping up their marketing of damage-protection products to pharmaceutical and life science companies, some say in response to a June report by the US Food and Drug Administration laying out a collaborative strategy to more closely track the quality of goods globally. In response to increasing regulatory activity, UK-based JLT Specialty, part of the Jardine Lloyd Thompson Group, has begun marketing such ‘nondamage’ products more aggressively this past summer—and they’re dropping their prices. The price of the insurance depends on a variety of conditions—for instance, the size of the company seeking insurance, the limits  … Read more

OPINION: Consistent clinical research standards benefit patients around the world

OPINION: Consistent clinical research standards benefit patients around the world

By Joe Herring Although the globalization of clinical trials has provided benefits to host countries, critics have focused on the rare but egregious examples of unethical practices. But large, coordinated trials by the contract research industry can encourage best practice, particularly if local countries adopt more consistent standards and oversight. As economic prosperity comes to developing nations, diseases associated with Western lifestyles, such as cancer and diabetes, are crossing borders. Meanwhile, developing countries are quickly becoming consumers of biopharmaceutical products. With the shared burden of disease comes the need to obtain safety and efficacy profiles across worldwide populations in a  … Read more

French law to make conflict of interest disclosure mandatory

By Sabine Louët France, still reeling from the Mediator scandal in which the diabetes drug (also known by its generic name, benfluorex) remained on the market until November 2009 despite earlier indications that it carried a risk of fatal heart valve trouble, is contemplating a revamp of its drug approval system. Lawmakers are due to discuss updates to the rules governing disclosures of conflict of interests by experts involved in the country’s drug approval process when the French National Assembly reconvenes at the end of September. As part of a draft bill reforming the drugs approval and safety system, France  … Read more

Q&A: Microbiologist takes helm of the European Institute of Innovation and Technology

Q&A: Microbiologist takes helm of the European Institute of Innovation and Technology

Although many of the world’s best known drugmakers hail from Europe, historically the continent’s academic institutions haven’t been as adept as their US counterparts at spinning off companies. So, in 2008, the European Commission founded the European Institute of Innovation and Technology (EIT) to bring technology and ideas developed at universities to market.  Read more

FDA reorganization inspires hope for better coordination

By Mike May In an agency-wide e-mail message on 13 July, US Food and Drug Administration Commissioner Margaret Hamburg unveiled a massive reorganization of the regulatory watchdog’s 41-year-old management structure. “The most obvious change you will see,” she wrote, “is that the Agency’s programs, in terms of a reporting chain to me, will be divided into ‘directorates’ that reflect the core functions and responsibilities of the Agency.” In addition to the existing offices, she said the FDA would also create a new Office of Operations as well as a deputy commissioner for Global Regulatory Operations and Policy “focused on grappling  … Read more