PharmTech Europe News

Ireland?s life-sciences sector has grown significantly since the 1960s. To gain insights into the competitive edge that Ireland offers to the pharmaceutical industry, Pharmaceutical Technology Europe spoke with Barry Heavey from IDA Ireland, which is a government agency responsible for attracting pharmaceutical and biotech companies to Ireland.

There has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Orphan drugs for rare diseases are a major area of investment for pharmaceutical companies, but are they becoming too expensive for Europe to afford them?

As the dreaded patent cliff continues to haunt the pharmaceutical industry, some companies are resorting to desperate measures to delay generic drug entry into the market.

With downsizing occurring more frequently than ever within the pharmaceutical industry, is Europe doing enough to curb further job losses that could threaten the recovery of its economy?

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Drug companies team up with INTERPOL to keep counterfeit medicines off the Internet and out of the hands of patients.

The outlook of the European biotech sector may not be as bleak as apparently believed despite the current economic climate, but compared with their US rivals, biotech companies are still struggling to attract investors and secure funding.

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

Has Europe's Innovative Medicines Initiative been successful in alleviating concerns regarding the region?s levels of pharmaceutical innovation?

The ongoing economic crisis in Europe has accelerated healthcare cost-containment measures targeting the price of pharmaceuticals, but the pharma industry is not giving in without a fight.

The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.

Vaccine manufacturing was predicted in 2008 to be on the cusp of a golden era, but instead the industry has experienced cost pressures, high-profile liability cases and production setbacks.

Nathan Jessop reviews the pharmaceutical industry's experience with the first year of Germany?s new pricing policy.

Regulators in both the EU and the US have attempted to stimulate paediatric-drug development with incentives offering extended periods of patent protection, but are these actions having the desired effects?

Germany has shifted from a market where the pharmaceutical industry could enjoy considerable pricing freedom to a sensitive market influenced by cost-containment policies.

Parallel trade has frustrated pharmaceutical manufacturers for years and now evidence has linked such trade to drug shortages in Europe. Parallel trade representatives have yet to respond, but will need to react quickly to salvage their reputation.

The globalisation of clinical trials is putting pressure on the European Medicines Agency.

Traditionally more prevalent in less industrialised regions, counterfeit medicines are now more frequently entering the heavily regulated supply chains of EU countries.

The scandal surrounding Servier's diabetes drug, Mediator, continues to unravel in France and could have implications for the whole pharmaceutical industry as the country scrutinises its regulatory systems.

The next two years may see a shake up in the world's current top pharmaceutical companies, with Pfizer likely to be the only US firm to remain in the top five by sales.

Despite the fact that Europe's population is ageing rapidly, the region is astonishingly still underprepared for dealing with the health-related effect of this demographic trend.

With the cardiovascular disease burden in Europe increasing, policymakers, regulators and other healthcare stakeholders are seeking to raise awareness and lessen the threat.

Electronic prescribing has grown strongly in the US but its future as a European-wide approach in healthcare has been uncertain; new regulatory interest could change the playing field.

Croatia is on track to join the EU in 2013 and offers a well-developed pharmaceutical market. However, its EU membership application has undergone much scrutiny.

Switzerland is an important power in Europe's pharmaceutical industry.

The greatest challenge faced by the EMA is the continuing expansion of the EU.

Despite initiatives to encourage multinational pharma companies to conduct R&D in the UK, the country may be losing its edge; is Pfizer's decision to exit a key site earlier this year the beginning of a mass exodus?

Europe's approach to pharmacovigilance has room for improvement that European agencies are working on.