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Chemistry World September 30, 2014 |
Transparency measures forced on pharma Previous misdemeanors are compelling the pharmaceutical industry to be more open with financial information and clinical data. |
Pharmaceutical Executive December 1, 2012 William Looney |
The Puzzle Master: Dr. Guido Rasi Europe's chief regulator charts a strategy from many moving parts. |
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, 2014 Phillip Broadwith |
EMA finalizes trial transparency rules The European Medicines Agency has finalized its policy for sharing data from clinical trials. |
Pharmaceutical Executive February 1, 2014 |
Will Europe's Regulatory Watchdog Come Of Age In 2014? The author looks at the growing pains of the European Medicine Agency as it faces key policy challenges of 2014. |
Pharmaceutical Executive September 1, 2008 Melanie North |
Publish or Perish FDAAA means that companies need to register clinical trials; and not only for publication planning. |
Chemistry World July 3, 2014 Andy Extance |
EMA wrangles restrain trial data progress Tempers are being tested as the pharmaceutical industry's journey towards transparency on clinical trial data enters a critical phase. |
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. |
Chemistry World February 7, 2013 Maria Burke |
GSK commits to AllTrials data disclosure GlaxoSmithKline has become the first pharmaceutical company to sign up to a high-profile campaign to make detailed data on all clinical trials available to the public. |
Pharmaceutical Executive March 1, 2014 Jill Wechsler |
Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance. |
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 September 5, 2014 Emma Stoye |
Servier to appear in adverts over lack of transparency European pharma group Servier Laboratories is to appear in adverts for breaching the Association of the British Pharma Industry code of practice by failing to publish clinical trial results. |
Chemistry World January 7, 2014 Angeli Mehta |
Flu drug stockpile may be worthless The case for spending hundreds of millions of pounds stockpiling antivirals for use in a flu pandemic is based on 'judgement rather than on evidence of their effectiveness', according to a parliamentary committee. |
Chemistry World October 17, 2012 Maria Burke |
GSK pledge on trials transparency GlaxoSmithKline has announced a series of initiatives to make clinical trial data publically available that could set a precedent in an industry not known for its transparency. |
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. |
Reason October 2007 Ronald Bailey |
Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest." |
Chemistry World June 26, 2012 Sarah Houlton |
Roche rapped for side-effect reporting failure Roche has been rapped by the European Medicines Agency for failing to report a large number of potential drug side-effects. The UK's Medicines and Healthcare products Regulatory Agency identified deficiencies in the company's medicine safety reporting system. |
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. |
Chemistry World February 4, 2014 Andy Extance |
J&J puts trial data in independent hands In a first-of-its-kind deal, Pharmaceutical firm Johnson & Johnson is making all of its drug trial data available via Yale University, US. |
Chemistry World August 7, 2013 Emma Stoye |
AllTrials releases plan for clinical trial reporting The organizations behind AllTrials, a public campaign calling for detailed information on clinical trials to be publically available, have put together a detailed plan on how to achieve clinical trial reporting on a global scale. |
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. |
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. |
Chemistry World January 3, 2013 Sarah Houlton |
2012 pharma industry roundup It may have been a relatively quiet year in terms of mergers and acquisitions, but the pharma industry nonetheless made plenty of headlines in 2012. |
Pharmaceutical Executive June 1, 2006 Jill Wechsler |
Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules. |
Information Today July 9, 2015 |
The BMJ Requires Patient-Level Data for Publication The BMJ is now applying its data-sharing policy to all clinical trials. |
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. |
Pharmaceutical Executive October 1, 2011 |
The Essential--and Effective--Bureaucrat Fernand Sauer, First Director General, European Medicines Agency, has witnessed the progressive sterilization of innovative research due to a trend toward ever-larger industry concentration. |
Pharmaceutical Executive November 1, 2006 |
Unraveling the eSource Industry-wide standards for electronic patient data have long felt like buried treasure. Companies today are getting closer - by way of a tangled map. |
Chemistry World November 27, 2012 Andrew Turley |
Roche and the Tamiflu data The Swiss pharma company has agreed to talk to external groups about full access to data for antiviral Tamiflu (oseltamivir) tablets, according to a letter published by the British Medical Journal. |
The Motley Fool July 10, 2006 Brian Lawler |
Northfield Frowns on Focus From "20/20" The maker of artificial blood finds yet another critic. But the impending end of the PolyHeme trial probably won't represent the end of criticism of the artificial blood. Only if good clinical trial results are announced later this year will Northfield's critics be silenced. |
Bio-IT World March 8, 2005 Mark D. Uehling |
Is That a Target on Her Back? Q&A with Deborah Zarin, head of ClinicalTrials.gov, the matchmaking Web site for patients seeking to participate in federally sponsored clinical trials. |
Bio-IT World April 2006 Mark D. Uehling |
Debating Clinical Registries and Databases The pharmaceutical industry has been forced by medical journal editors and Congress to make public more data about clinical trials. Registries are here, most people are used to them, and they're not going away. But can the industry do registries and databases better? |
Bio-IT World March 10, 2003 Kenneth Getz |
E-Clinical Technology Overview Clinical trial researchers want to leverage the benefits of IT -- and now they can for every core process. But they also have to get past the barriers to adoption. |
Pharmaceutical Executive March 1, 2013 |
Who's Really in Charge of European Drug Registration? The European Commission blocks the authorization of a life-saving liver drug outside of France. |
Pharmaceutical Executive June 1, 2005 Joanna Breitstein |
Turn the Page Changes in ethics and expectations are driving the way pharma interacts with medical publishers. |
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? |
Chemistry World July 10, 2012 |
Interview: EMA head Guido Rasi His five-year appointment comes during a period of dramatic change for the pharma industry, which is struggling with patent expirations for many of its biggest selling drugs and a paucity of new drugs coming through the pipeline to take their place. |
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. |
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. |
Chemistry World March 4, 2013 Andy Extance |
UK considers patent rule change for trials The UK has announced plans to amend aspects of its patent law that may be encouraging pharma companies to run their clinical trials in other countries. |
The Motley Fool December 8, 2004 Alyce Lomax |
Eli Lilly Bares All The pharmaceutical publishes clinical trial results online. This is a step toward generating trust -- after all, shareholders, physicians, and consumers alike are likely looking askew at Big Pharma these days. |
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. |
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. |
Chemistry World July 25, 2006 Bea Perks |
Clinical Chaos Under Scrutiny Clinical trials of new drugs need to be tightened up, according to an expert group convened in the aftermath of UK trials that left six people fighting for their lives. |
The Motley Fool June 21, 2004 Brian Gorman |
Clinical Trials Controversy The American Medical Association wants more transparency in clinical trials, a proposal that may leave drug companies and investors with mixed feelings. |
Pharmaceutical Executive May 1, 2005 Sarah Houlton |
Global Report: Iron Fist The United Kingdom is hardening its stance on pharma industry issues. |
Chemistry World February 26, 2008 James Mitchell Crow |
Q and A: Do Antidepressants Work? A widely-reported analysis of clinical trial data for Prozac and related antidepressant drugs has claimed that the medicines work little better than chemically-inactive placebos in all but the most severely depressed patients. |
Pharmaceutical Executive March 1, 2012 |
The Italian's Job After his predecessor and countryman left the EMA in disgrace, Guido Rasi jumps in as executive director with great challenges ahead. |
Chemistry World February 26, 2014 Ned Stafford |
Roche disputes unethical East German trial claims Clinical trials in the 1980s, performed in former communist East Germany by global pharmaceutical giant Hoffmann-La Roche, adhered to international standards and did not violate East German laws, according to a report issued by the company after a six month internal investigation. |
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. |