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Pharmaceutical Executive
December 1, 2012
William Looney
The Puzzle Master: Dr. Guido Rasi Europe's chief regulator charts a strategy from many moving parts. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2012
Here's to a Happier New Year? A turbulent year is ahead for European pharma, while EFPIA's Director General begins to rethink its approach to new science. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2012
Europe's Trust Gap For the second time in recent memory, a top European regulator leaves office abruptly and under a cloud of suspicion. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2012
Peter O'Donnell
Richard Bergstrom -- Europe's Medicine Man The new head of the European Federation of Pharmaceutical Industries and Associations faces a Promethean challenge: selling the merits of costly science and innovation in an era of bristling competition, fiscal crisis, and declining demographics. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2014
Eruptions on the Drug-Pricing Horizon in Europe An escalating political debate over pharma pricing and reimbursement nears the boiling point. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2011
Europe's Transparency Directive Revisited The effect on pharma of the EU's Transparency Directive has been overly constraining, but will the mooted revisions offer any room to maneuver? mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2011
Richard Gliklich
The Power of Observation Observational studies present a compelling real-world corollary to the classic randomized clinical trial. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Chemistry World
October 9, 2013
Phillip Broadwith
GSK to apply for malaria vaccine approval Preliminary results from the first ever Phase III clinical trial of a malaria vaccine show that it can reduce malaria infections in vaccinated children over 18 months. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2014
Jill Wechsler
Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2006
Sarah Houlton
Global Report: Please Come Back Health authorities in Europe are working hard to reestablish their countries as preferred locations for pharma's R&D facilities. Fortunately, they've got a blueprint: China. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2011
A Lack of Information Why has the EU still not managed to update its rules on information about medicines? mark for My Articles similar articles
Pharmaceutical Executive
January 21, 2014
Comer & Upton
Pharm Exec's Annual Industry Outlook 2014 For Big Pharma, the merits of strategic focus and operational discipline are more important than ever. It is time to be decisive; muddling through is so yesterday. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2014
Whatever Happened To Faster Reimbursement For Generics In Europe? The plan to accelerate generic pricing and reimbursement has become another tragic European casualty. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2005
Sarah Houlton
Global Report: Kids 'R' EU After years of delay, the European Parliament is ready to vote on pediatric-testing legislation. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2005
Sarah Houlton
Global Report: Iron Fist The United Kingdom is hardening its stance on pharma industry issues. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2011
Europe in HTA Gridlock Health technology assessments are gridlocked by diverse national requirements, a lack of alignment on processes, and even on the value of their outcomes. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2014
EFPIA's 'Integrated Strategy' in Europe: Out of the Frying Pan, Into the Fire? Industry's grand vision for reshaping the life sciences in Europe may ultimately prove to be a lost cause. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2014
Hopes High as EU Heads Into Leadership Change The principal drug industry associations in Europe launched a call in mid-May for "an integrated European industrial policy for the pharmaceuticals sector." mark for My Articles similar articles
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. mark for My Articles similar articles
Chemistry World
September 24, 2010
Andrew Turley
End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use. mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2013
Pharma Bids for European Funding in New Research Program The euro 70 billion budget is still subject to final agreement on the European Union's overall spending plans for 2014-2020. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2009
Sarah Houlton
Reforms Offer Good News for Trade European Commission proposal loosens restrictions on drug packaging and information dissemination. mark for My Articles similar articles
Bio-IT World
April 16, 2004
Joel Hoffman
Taking the Trial Out of Clinical Outsourcing Make sure the vendor's standard operating procedures will mesh with your own, and then tirelessly work toward systems integration. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2012
William Looney
2012: Year of Record The calendar says its wrap-up time, not just for gifts but for some of the trends that shaped the industry for good or bad in the year 2012. mark for My Articles similar articles
Chemistry World
May 23, 2012
Andy Extance
Drug watchdogs mark out global territory The US Food and Drug Administration has published plans to ensure that American citizens continue to enjoy access to safe drugs, even as the regulatory pressures of globalization grow. mark for My Articles similar articles
Pharmaceutical Executive
July 1, 2011
Holy Surge of Enthusiasm! While Europe's EFPIA preaches about embracing change, much remains to be done to prove the adjustment in philosophy. mark for My Articles similar articles
Bio-IT World
August 2005
Ellen H. Julian
Tech Expertise Singles Out Outsourcers Biopharmaceutical companies are flocking to consultants, outsourcers, and staffing firms to help with discrete clinical trial processes to gain access to advanced technologies and reduce the drain on already-scarce IT resources. mark for My Articles similar articles
The Motley Fool
April 15, 2011
Brian Orelli
Fewer Needle Pricks for the Europeans Amylin's once-weekly diabetes drug Bydureon gets a positive recommendation in Europe. mark for My Articles similar articles