Category Archives: Guest Blog

Gain Competitive Advantage: Think Like a Navy SEAL

Pharmaceutical professionals, teams, and organizations can succeed at an elite level by tackling the tough mental challenges of Navy SEAL training, writes Stan Bernard. Victorious warriors win first in their minds, and then go to war. Defeated warriors go to war first and then seek to win. — Sun Tzu, Author of The Art of War (544 BCE-496 BCE) […]
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Major Changes to EU Clinical Trials Regulation

Earlier this year, the newly approved EU Clinical Trials regulation (No 536/2014) was published in the Official Journal of the EU (OJEU).  The European Commission (EC) estimates that all the changes could save researchers €800 million (over $1 billion) a year. It replaces the existing EU Clinical Trials Directive (2001/20/EC), which was intended to simplify […]
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UK’s Controversial Cancer Fund Boosted — But What’s the Long-Term Plan?

By Leela Barham. The English Cancer Drugs Fund (CDF), set up to provide funding for those products that the National Institute for Health and Care Excellence (NICE) has not recommended for use or where their guidance isn’t yet available, remains controversial. Initially penciled for closure in 2014, it is now planned to run to 2016. […]
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Europe: More Direct-Acting Antivirals, More Controversy

The storms raging across Europe—and beyond—over the pricing of new hepatitis C treatments have been intensified by the European Union’s approval last week of the latest directly-acting antiviral, Bristol-Myers Squibb’s Daklinza (daclatasvir). Just two months after the European Medicines Agency gave a positive opinion on the drug, the formal authorization was delivered for use in […]
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From the Generic to the Supergeneric Era

By Adeline Siew, Pharmaceutical Technology. Generic drugs save patients and European healthcare systems approximately EUR 35 billion (US$46bn) each year, according to the European Generics Association (EGA). Of the 16 health-related recommendations made by the European Commission for 2014–2015 to EU member states, 11 concerned cost efficiency in the healthcare sector. But, speaking at the EGA […]
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