This report provides a comprehensive review of current drug approval trends in the US and Europe with case studies highlighting successful and unsuccessful applications.

A comprehensive overview of companies launching drugs in the US and 5EU markets during 200206, with key case study analysis of both successful and unsuccessful drug launches and forecast analysis of drug launches through 2012.

Over the next 10 years a significant number of key oncology products, some with blockbuster status, will lose patent protection, thus exposing billions of dollars to generic erosion. While obviously a major threat to the key pharmaceutical players and

A series of high profile safety concerns, such as the withdrawal of Vioxx (rofecoxib) and the link between antidepressants and suicidal thoughts in children over the last two years has made drug safety a major issue for governments, regulatory authorit

The established ban on Direct-to-Consumer advertising in the European Union poses a unique challenge to the traditionally brand-driven pharmaceutical industry. In lieu of aggressive television and print-based promotional campaigns, companies must inste

This report will help you create an effective pricing policy, in the midst of continued regulatory uncertainty, stagnant R&D and the continued cost-containment efforts of healthcare payors.

This report examines the actions taken by legislative and regulatory bodies in response to recent drug safety concerns surrounding the COX-2 inhibitors and antidepressants.

The coming year will be one of immense change for the pharmaceutical industry in Europe. The continued development of the eEconomy is critical to the continued growth and success of the European pharmaceutical market. Companies that implement forward-l

The pharmaceutical industry is experiencing an increased level of government regulatory intervention. Achieving compliance is of primary concern to every company in the industry. In order to successfully implement eHealth regulations and avoid federal

Long-term usage of HAART for the management of HIV has reduced mortality in the HIV-infected population. However, this has consequently led to an increase in the prevalence of chronic co-infections such as Hepatitis B (HBV). Currently, HBV prevalence e

Antibacterial players are currently facing significant hurdles in terms of increasing and maintaining product revenue. These include growing resistance across classes, greater restrictions relating to the use of antibacterials and an expected increase

The UK Department of Health (DoH) has introduced a key policy concerning the reissuing of patients’ own pharmaceuticals on admission into hospital, determining that this will save money and improve quality of care.

This report examines a

The oncology therapy area is unlikely to be spared from the heightened conservatism currently sweeping the regulatory environment. This is evidenced by the increased scrutiny with which the FDA appraises accelerated approval applications, particularly

The drive for increased cost savings by healthcare providers is increasing the focus on boosting the biosimilar market. With a regulatory approval pathway in place in Europe and substantial guidelines to support biosimilar development, the European bio

Survey data currently indicate that 60% of participating companies structure their field-based MSL programs under medical affairs to further accentuate the function’s scientific emphasis.

This report analyzes the practices of some of the industry’s top medical affairs departments to provide the steps medical affairs departments must take to make their functions more integral pieces of the overall company picture.