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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.  |
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.  |
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 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 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.  |
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.  |
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 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 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.  |
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.  |
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.  |
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 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.  |
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.  |
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.  |
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.  |
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.  |
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.  |
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.  |
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 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?  |
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.  |
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.  |
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 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, 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 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.  |
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.  |
Pharmaceutical Executive March 1, 2014 Jill Wechsler |
Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance.  |
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.  |
Pharmaceutical Executive June 1, 2011 |
A Lack of Information Why has the EU still not managed to update its rules on information about medicines?  |
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.  |
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.  |
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.  |
Pharmaceutical Executive May 1, 2005 Sarah Houlton |
Global Report: Iron Fist The United Kingdom is hardening its stance on pharma industry issues.  |
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 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.  |
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.  |
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.  |
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."  |
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.  |
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.  |
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.  |
Pharmaceutical Executive February 1, 2009 Sarah Houlton |
Reforms Offer Good News for Trade European Commission proposal loosens restrictions on drug packaging and information dissemination.  |
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.  |
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.  |
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.  |
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.  |
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.  |
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.  |