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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. |
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. |
Chemistry World April 5, 2013 Phillip Broadwith |
Roche to release Tamiflu trial data Swiss pharma company Roche has finally agreed to give independent researchers access to data on all 74 clinical trials it ran on the antiviral influenza drug Tamiflu (oseltamivir). |
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. |
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. |
Pharmaceutical Executive May 1, 2005 Sarah Houlton |
Global Report: Iron Fist The United Kingdom is hardening its stance on pharma industry issues. |
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 November 1, 2014 |
EMA -- a Pioneer Permanently At Bay Agency's plan for reporting clinical trial data has sparked strong reactions from health campaigners, industry, and patients. |
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 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. |
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. |
The Motley Fool May 28, 2009 Brian Orelli |
How to Make a Stockpile in Your Portfolio The swine flu has turned out to be a relative dud, hasn't it? It hasn't done much but create a buying opportunity for those who didn't panic. Where should you look to profit from it now? |
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 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. |
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 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. |
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 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 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 March 17, 2014 Phillip Broadwith |
UK to fast-track access to critical medicines Critically ill patients in the UK could receive new medicines before they are formally approved under a new scheme beginning in April. |
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 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. |
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. |
The Motley Fool March 30, 2006 David Compton |
Glaxo's New Flu-Fighting Ammo The FDA certifies the drugmaker's Relenza for defense as well as offense. For investors seeking to give their portfolios a shot in the arm, now might be the time to take a closer look at Glaxo. |
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 November 13, 2009 Brian Orelli |
Questioning Pfizer's Integrity Pfizer's epilepsy drug Neurontin has had generic competition for a few years, but it's still plaguing the pharmaceutical giant. |
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 April 27, 2009 Brian Orelli |
A Capitalist Pig's View of Swine Flu So you want to make money from the swine flu? Here's how to do so. |
Managed Care April 2007 MargaretAnn Cross |
Do P&T Committees Have Enough Power? Plans and PBMs are divided about sharing drug prices with clinicians. Is it better to have an administrative committee determine the formulary? |
Chemistry World February 2, 2015 Rebecca Trager |
EU regulator calls for generic drug suspensions The European Medicines Agency) has accused an Indian contract research organization of systematic fraud, and has recommended suspending sales of hundreds of generic drug formulations in Europe. |
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. |
Chemistry World January 15, 2014 Dinsa Sachan |
Radical drug rule changes hit buffers in India A parliamentary panel in India has slammed a proposed bill seeking to radically alter the way drugs are regulated in India. The panel's report has essentially put reform of medicines in the country on ice, according to observers. |
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. |
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. |
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 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 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 October 17, 2005 Brian Gorman |
Chasing Down Bird Flu Sanofi and GlaxoSmithKline are emerging as the likely winners in the race to produce a bird flu vaccine. |
The Motley Fool March 29, 2010 Brian Orelli |
Look for Companies That Strike First Head-to-head trials, whether they're run by companies or by third parties, can be scary. But the way to make big money is by selling drugs that offer superior benefits, so investors should welcome the onslaught of upcoming comparative trial 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. |
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? |
Chemistry World October 8, 2010 Sarah Houlton |
U-turn on Alzheimer's drugs in the UK The UK National Institute for Health and Clinical Excellence proposes that those with mild disease will be able to receive them from early next year, on the basis of growing clinical evidence of their effectiveness. |
The Motley Fool November 29, 2007 Brian Lawler |
Another Chapter in Glaxo's Relenza Saga An FDA advisory panel suggested that the Relenza label should be strengthened to include the possibility of abnormal behavior and hallucinations in those who take it. |
The Motley Fool October 17, 2008 Brian Orelli |
Gilead Sciences Killed It The virus-killer kills analysts' expectations, as well. The company blows through analysts' expectations with its third-quarter results. |
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. |
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? |
Pharmaceutical Executive June 1, 2006 Sarah Houlton |
Global Report: People Problems A recent clinical trials disaster is causing UK regulators to consider revising its guidelines for Phase I human studies for biologics. However, in many cases, potential solutions present additional problems. |
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. |
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. |