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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 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 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 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 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 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. |
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 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 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. |
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 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 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 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 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 June 1, 2012 |
2012 Dealmakers Outlook With Yankee Stadium as the backdrop, Pharm Exec convened on its annual panel of heavy hitters in business development to crack the bat on best practices in licensing and for the year ahead. |
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 October 1, 2010 |
Nobel Laureate Elie Wiesel Exclusive Interview Ethical behavior can be a bridge-builder in an era where Big Pharma needs to find new partners. Is it up to the challenge? |
Pharmaceutical Executive January 1, 2011 |
The San Diego Story San DIego works as a locus for risky investments in the big ideas that lead to biotech breakthroughs |
Pharmaceutical Executive September 1, 2010 |
Looking Beyond the Patent Cliff Pfizer's VP and Assistant General Counsel for Global Patents and Policy, Roy Waldron, discusses its collaborative strategy to refresh the face of IP. |
Pharmaceutical Executive December 1, 2011 William Looney |
The Medicines Adherence Challenge Keeping skittish patients on their medicines ought to be a strategic priority for Big Pharma, but is it? An expert round table examines how best to make progress and agree on some practical steps for incorporation in the campaign agenda. |
Pharmaceutical Executive November 1, 2014 William Looney |
Pharma Science: It's Hard Amid a resurgence in drug development for hard-to-treat conditions, the bigger question is whether the times are as good for the industry tasked with rendering basic science into therapeutically effective medicines. |
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 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 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 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 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 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 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 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 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, 2011 William Looney |
To Align an Audience, Find a Pulse All this uncertainty at the back end of drug development is a drain on future therapeutic progress against disease. It's a job killer, too. |
Pharmaceutical Executive November 1, 2012 Clark Herman |
Prix Galien: Night at the Museum Representatives of Big Pharma and trade association leaders at the New York Museum of Natural History had one purpose in mind: to recognize the latest innovations in new drugs and medical devices. |
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 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 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. |
Pharmaceutical Executive November 1, 2013 William Looney |
Payers: Late for the Party? Pharm Exec's two key features this month illustrate the strategic contradiction facing today's industry. |
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. |
The Motley Fool July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
Pharmaceutical Executive January 1, 2013 Clark Herman |
Who Lost Syria? Thankfully, the civil war is not a public relations issue for Big Pharma, but the long-term business implications for the Middle East region are cagey. |
Pharmaceutical Executive September 1, 2011 Jill B. Conner |
Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs. |
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. |
Chemistry World December 2, 2013 Lanay Tierney |
US turnaround on Avandia restrictions Restrictions on the controversial diabetes medication Avandia (rosiglitazone) are to be lifted by the US Food and Drug Administration. |
Pharmaceutical Executive December 1, 2011 William Looney |
2011: End of the Beginning The gap in perception is one of industry's biggest problems because it adds ballast to the idea that medicines are just a simple procurement item. |
Chemistry World December 17, 2015 Sarah Houlton |
Pills, prices and politics Pharmaceutical pricing has been a hot topic in 2015, with the drugs bill continuing to rise as costly new treatments reach the market. |
Chemistry World August 21, 2015 Sa njay Kumar |
Indian pharma under increased regulatory scrutiny A Europe-wide ban on hundreds of generic pharmaceutical formulations tested by Indian contract research firm GVK Biosciences comes into force today. |
Pharmaceutical Executive May 1, 2012 William Looney |
Seeding Beyond the Base The pharmaceutical industry's reputation as a growth industry no one wants to pay for is more secure than ever. |
Pharmaceutical Executive July 1, 2012 William Looney |
Less, But Better Pharm Exec's 2012 roster of Emerging Leaders is not only a way to recognize a few individuals who've made a difference in their organizations. It also serves as a barometer to track larger changes in the workplace. |