$1-$13 million a day at risk from product launch delays

22 March 2004

The pharmaceutical sector has witnessed the introduction of a record 44 new clinical research regulations since 1995, and is reluctantly bracing itself for more with only two months left for European Union member states to implement the Clinical Trials Directive into law, due May 1 (Marketletter March 15). All eyes are now on what could potentially be the greatest shake up of clinical trials in decades, says UK-based clinical trials data management specialist Phase Forward.

Driving these changes is medicine safety, as highlighted by GlaxoSmithKline's experience with the European Medicines Evaluation Agency's investigation into Seroxat/Paxetil (paroxetine) after claims of serious side effects, and AstraZeneca's need to delay the launches of two of its newest drugs, Iressa (gefitinib) and Crestor (rosuvastatin), due to safety issues, it notes.

This spotlight on safety means companies and regulators are looking to utilize the data collected by safety groups to better effect. This is unsurprising, comments Phase Forward, considering:

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Today's issue

Company Spotlight