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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 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.
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 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 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 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, 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.
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.
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 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 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 February 1, 2006 Sarah Houlton	Global Report: Moving Towards Generic Biologics The European Medicines Agency hopes to complete its guidelines for the approval of biosimilar drugs early this year, paving the way for the approval of biogenerics - and a potential goldmine for the generics companies.
Pharmaceutical Executive April 1, 2011	Dalli's Formula Fails the Efficacy Test EU leadership on pharma policy leaves many wondering of the right man is at the helm.
Pharmaceutical Executive February 1, 2012	Industry/Gov't R&D Support: So Far So Good The EU's Innovative Medicines Initiative is helping to invigorate new drug development, but there are still many hurdles to tackle before its promise is realized.
Pharmaceutical Executive June 1, 2011	A Lack of Information Why has the EU still not managed to update its rules on information about medicines?
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 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?
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 May 1, 2005 Sarah Houlton	Global Report: Iron Fist The United Kingdom is hardening its stance on pharma industry issues.
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 May 1, 2011	Seeing Through the Transparency Directive The EU is largely powerless when it comes to policies over pharma pricing and reimbursement.
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.
Chemistry World November 28, 2008 Matt Wilkinson	EU claims pharma delaying tactics cost 3 billion euros Pharmaceutical manufacturers have been criticised by the EU competition commission for slowing the entry of generic medicines to the market.
Pharmaceutical Executive November 1, 2011	Does a German Launch Make Sense? Will the structure and ambiguity of Germany's new medicines pricing system bring a halt to new drug launches in Europe's largest market?
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 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 May 1, 2012	Value-Based Pricing: Too High a Price for UK Pharma? Changes to the system in the UK could finally put some real metrics behind the elusive concept of value but with payers clearly in the driver's seat, who needs clarity?
Chemistry World May 2006 Bea Perks	Editorial: Generics in the Dock The manufacturers of generic medicines in the U.K. must work harder to guard their good reputation. Or perhaps, manufacturers of generic medicines must work harder to counter their bad reputation.
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 January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
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 August 2, 2007 Victoria Gill	Europe Poised for a Surge in Generic Drugs The European Medicines Agency's Committee for Medicinal Products for Human use has recommended the approval of a schizophrenia treatment which is the first generic drug to be assessed under Europe's centralized procedure.
Pharmaceutical Executive December 1, 2010 William Looney	In Through the Out Door The end of anther year is an appropriate time to highlight the march of time and the transitions that accompany it in Europe and in China.
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, 2011	Europe Tackles 'Advertising in Disguise' Fears The EC's latest proposals have thrown water on Europe's fiery Direct-to-Consumer advertising debate. But is it enough to keep the flames at bay?
Pharmaceutical Executive December 1, 2005 Patrick Clinton	PharmExec's 2006 Forecast The 2006 pharmaceutical industry is under assault from Congress, the press and the public, add a complex government program that will unimaginably change industry economics, and subtract revenues from off-patent products.
Pharmaceutical Executive November 1, 2006 Sarah Houlton	Global Report: 'Bout Time The European Union has been late to enter the fight against counterfeiting. Fed up, Parliament has passed a proposal designed to give its countries the nudge they need.
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.
Pharmaceutical Executive May 1, 2007 Sarah Houlton	Global Report: Pure and Simple The european union is set to overhaul the way it monitors drug safety to help make sense of a decentralized system that has been criticized for being ineffective. Will the EC's upcoming drug-safety plan be just what the doctor ordered or end up an indecent proposal?
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.
Chemistry World April 2007 Richard Barker	Comment: Pricing Pills An Office of Fair Trading report claims The UK's National Health Service is paying over the odds for its drugs, but this is not so. Medicine prices are 21% lower in real terms than ten years ago.
Chemistry World February 14, 2012 Rebecca Trager	FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones.
Pharmaceutical Executive January 1, 2006 Sarah Houlton	Global Report: The UK's New Code of Conduct Pharma companies' relationships with doctors are being tightened in the United Kingdom, after a major overhaul of the Association of the British Pharmaceutical Industry's Code of Practice.