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Pharmaceutical Executive May 1, 2005 Sarah Houlton	Global Report: Iron Fist The United Kingdom is hardening its stance on pharma industry issues.
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 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.
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.
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 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 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 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 May 1, 2006 Madison, Chan & Seeger	Making the Link The FDA recognizes that a new drug standard must evolve -- one of routine, proactive safety surveillance. But post-marketing safety studies are too slow. Here's how pharmaceuticals are using claims databases to solve the problem.
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 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 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.
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.
Bio-IT World June 2005 Judy Hanover	Drug Safety - Issues & Opportunities Information technology, specifically safety databases and concomitant data-mining efforts, holds great promise for providing a potential solution to daunting drug safety problems, despite lingering uncertainty.
Pharmaceutical Executive November 1, 2005 Sarah Houlton	Global Report: Drug Evaluation in the UK The availability of new medicines has been thrown into the limelight once more, with UK's National Institute for Health and Clinical Excellence being called upon to make dramatic improvements to the speed at which it carries out evaluations.
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 October 10, 2012 Maria Burke	Illegal medicines seized in worldwide operation During the nine-day operation, coordinated by INTERPOL and involving 100 countries, around 18,000 illegal online pharmacy websites were shut down and 79 people were arrested.
Pharmaceutical Executive December 1, 2006 Sarah Houlton	Global Report: Not So NICE A new manifesto by the Association of the British Pharmaceutical Industry is designed to improve drug access in the UK, where industry has worried for years about poor uptake of new medicines.
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 October 1, 2011	Regulation and Reputation: Still Two Solitudes The pharmaceutical and biopharmaceutical industries will only be able to continue providing patients with safe and effective medicines if the price is affordable. This will involve changes in attitudes by the industry, regulators, politicians, and the public.
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 December 1, 2012 William Looney	The Puzzle Master: Dr. Guido Rasi Europe's chief regulator charts a strategy from many moving parts.
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.
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 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 December 8, 2006	Expert Guidance on Clinical Trial Safety Clinical trial design in the UK is due for a shake up following the recommendations of an expert group commissioned in light of a disastrous trial that left six subjects fighting for their lives.
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 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.
Pharmaceutical Executive April 1, 2007	Thoughtleader: Melissa Brown, Center for Value-Based Medicine Here, co-author Melissa Brown discusses her book Evidence-Based to Value-Based Medicine and what's driving the move toward value-based medicine, how it will affect pharma, and why executives should embrace it.
Pharmaceutical Executive June 1, 2013 Clark Herman	Adherence's New Players: Fresh Support from the Sidelines New stakeholders, innovative technologies, and emergent synergies in government are combining to build fresh momentum behind the old issue of medication adherence.
Bio-IT World December 15, 2003 Kevin Davies	The Road to Personalized Medicine FDA guidance on the road to genomic medicine is a welcome first step in what promises to be a contentious debate on how to integrate pharmacogenomics into routine medical practice.
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 June 1, 2011	A Lack of Information Why has the EU still not managed to update its rules on information about medicines?
Chemistry World December 19, 2013 Steven Ford	Cut price pills cost more than pennies We need to take a good look at supply diversity: we cannot allow the situation where suppliers are too big to fail. It's time to raise the bar across the pharmaceutical supply line from producer to patient.
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.
Pharmaceutical Executive June 1, 2006 Nancy Dreyer	Personalized Medicine Meets the Real World A wave of genomic medicines is coming down the pipeline, and they're going to be expensive. Can companies prove they're worth it? Maybe: but the claims payers seek aren't coming from traditional clinical trials.
Pharmaceutical Executive August 1, 2012 Carol Ann Williams	Data Exclusivity: Making the Case As the scope and complexity of registration information demanded by regulators increases, protection of that know-how has become a critical differentiator in the "go" or "no go" calculation on whether to invest in a new medicine.
The Motley Fool January 7, 2011 Brian Orelli	Dendreon Heads Across the Pond A pathway to Provenge approval in the EU.
InternetNews November 11, 2010	Data Breaches Cost Hospitals $6B A Year: Study Ponemon Institute report finds that healthcare organizations suffer an average of 2.4 data breaches a year, costing in excess of $2 million per incident.
Pharmaceutical Executive November 1, 2012 Lauri Mitchell	Who Pays for Specialty Medicines? Providers and patients fish for that delicate balance between access and abandonment.
Pharmaceutical Executive April 1, 2011	Bridging the HCP-Patient Gap Here's what's necessary to bridge the gap between the patient revolution and healthcare provider in the 21st century.
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 October 1, 2008 Sarah Houlton	Open For Debate Tensions mount as stakeholders in the UK health industry attempt to work out drug cost problems.
Chemistry World July 2008 William Bains	Beyond shareholder returns The author offers a new model for the pharmaceutical industry
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 September 1, 2012	Patients Wade Into the Pricing Debate Europe's fiscal crisis is becoming a new rallying cry for patient groups, but regional unity is still elusive.
Chemistry World January 28, 2015 Rebecca Trager	Roche chases bolt-on acquisitions as it pushes into genomics A recent spending spree by Roche is intended to take advantage of emerging molecular information and genomic analysis, as the company anticipates that the field will play an increasingly important role for future medicines and diagnostics.
Chemistry World March 21, 2013 Andy Extance	Court convicts ex-Aptuit researcher over drug data Steven Eaton, a former employee at drug discovery and development firm Aptuit's Riccarton site in Scotland, produced flawed data over six years.
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.