EuroPharma Today

Medical Device Market 2009: Interventional Cardiology

Elsevier Business Intelligence announces the publication of a new Special Report: Medical Device Market 2009 Interventional Cardiology. Who’s going beyond catheters and drug-eluting stents in this vibrant space. A special report previously published in IN VIVO: The Business & Medicine Report™  Read more...

Promising Phase III Data For Roche/Ipsen's Taspoglutide Heats Up GLP-1 Race

Roche and Ipsen's release of the first Phase III data for their human glucagon-like-peptide-1 analog taspoglutide may not have given more than a peek at top-line results, but it does showcase the changing dynamics of the GLP-1 development field--and hints at what may prove a significant boost to mid-sized Ipsen, the drug's originator.

Roche Taps Russian HIV Opportunity With Viriom Deal

In a first-of-its kind deal, Roche recently licensed a handful of pre-clinical HIV assets to Russian biotech Viriom, a start-up created specifically to develop and commercialize the compounds in Russia, Ukraine, Belarus and Kazakhstan.

EU Approval For Movetis' Resolor Validates Its Targeted Strategy in GI Disorders

Big Pharma has largely eschewed the risk-reward profile associated with many gastrointestinal drugs. But the Oct. 23 European approval of Movetis NV's Resolor in a subset of constipation patients demonstrates there are ways to improve the odds of success, albeit in smaller markets.

Special report on REMS: Industry’s Newest Fast-Track to Approval

FDA’s REMS Program: How It Can Hurt – or HELP – your Drug
Guidance for a smooth approval process & working successfully with the new requirements

FDA's new power to require Risk Evaluation and Mitigation Strategies (REMS) as part of a drug’s approval could be the most important change to FDA’s authority in the last 20 years. The questions for drug sponsors are abundant: How often are REMS provisions required for new drugs? What could trigger a REMS requirement for my drug? What types of REMS provisions are typically required? At what stage of drug development should I start planning for REMS? Will my drug be delayed while I negotiate REMS requirements with FDA? Are there any commercial opportunities I can turn to my advantage from having a REMS?

In this Special Report, you get answers to all these questions and many more, from our analysis of the most important REMS programs to date, to the specific regulatory and commercial experiences of the first companies to go through the REMS process.

This detailed 43-page report includes critical information for regulatory, legal, R&D, and business development executives, and anyone who works for or with biopharma companies to meet the new REMS requirements. Get this exclusive report now! Follow this link for details.

Backing European Biotech (Part 2): Regional Support Structures Lure Companies from Overseas

Several of Europe’s most important soft-money initiatives are happening at the regional level.  In Part 2 of our series ‘Backing European Biotech’, we focus on Belgium, whose North-Eastern region of Limburg is beginning to stand out as a particularly attractive venue for biotech.  Substantial tax breaks are one key driver; another is LRM, originally a regional government regeneration fund but now more like a VC, offering funding, support and, increasingly, infrastructure.

Backing European Biotech: A Growing Role for National & Regional Initiatives (Part 1)

In tough economic times such as today’s, government ‘soft money’—loans and grants designed to support what’s often a fledgling sector in most economies—arguably takes on a more important role.  The downturn has triggered several new—or invigorated—government initiatives across Europe, both at national and regional level.   Part 1 of this mini-series looks at Norway, which hit the headlines at the beginning of the year with a €318 million ($475 million) package of grants, soft money and loans for innovative industries.  Is the scheme working?

GlaxoSmithKline in a Rare-Disease Pact with Prosensa for RNA-modulation Drugs

In another sure sign of Big Pharma's recent embrace of specialist diseases, GlaxoSmithKline on Oct. 13 announced a deal for four compounds with Holland's Prosensa, which is focused on RNA-modulating therapeutics for Duchenne Muscular Dystrophy.

Pay-For-Performance Hits France As Part Of Cost-Cutting Measures

Facing a €11 billion ($16 billion) deficit in 2009 in its state-funded health service - which is forecast to reach a whopping €17 billion next year - French ministers announced in late September a series of measures to help curb spending growth.

Top China Health Reform Insider To Speak At PharmAsia Summit In San Francisco

Dear Colleague:

In the last year, I have had the good fortune to visit with Song Ruilin several times during my travels to China. Professor Song is the Executive Director-General of the China Pharmaceutical Association's Research Center for Medicinal Policy and Chairman of the Chinese Journal of New Drugs. He is among the most influential figures in China healthcare reform and pharmaceutical policy. He rarely speaks publicly and seldom visits the U.S.