Small molecule drug, Niraparib combined with abiraterone acetate (AA) and prednisone (P) significantly reduces the risk of disease progression, or death, in patients with a type of prostate cancer, a consultant in Spain has said.
The regulatory agencies of six European countries are now actively prompting clinical trials sponsors to publicly report their clinical trial results—and have the power to issue fines of up to €250,000 ($243,000) for noncompliance.
Pharmaceutical and chemical manufacturers may have to wait until 2017 to see the benefits of the Transatlantic Trade and Investment Partnership, VP of SOCMA (Society of Chemical Manufacturers and Affiliates) told attendees at InformEx in New Orleans.
The European Medicines Agency (EMEA) has called for “in-depth, prospective analysis of potential ethnic factors” when considering whether clinical trials conducted outside the EU will be acceptable in marketing authorisation applications.
Ranbaxy has been granted an EU manufacturing and import license for
its Romania-based Terapia Ranbaxy subsidiary, and says it will make
the company a strategic regional hub for its operations in Europe.
A new international agreement will eliminate customs duties on
pharmaceuticals and chemical intermediates traded between the major
nations dealing in the industry. The move is set to save EU
pharmaceutical companies around €230m in...
EU ministers yesterday agreed on a compromise version of the
controversial new chemicals law, REACH, however environment groups
have condemned the latest changes as a further watering down of the
law in favour of industry.
The US Biotechnology Industry Organisation has come out in support
of European legislation that it says will require extensive tests
to be conducted on so-called 'biosimilar' versions of biological
The European Court of Justice has ruled that Internet sales of
prescription drugs should not be permitted in European Union member
states but that over-the-counter drugs may be sold on-line and
The innovation gap between the EU and the US will not be closed
before 2010 if the present rate of progress continues, according to
new figures contained in the Commission's European innovation
scoreboard for 2003.
The Eurobarometer 2002 survey on 'Europeans and biotechnology'
reveals that despite the impression that Europeans are sceptical
about this technology, the majority are optimistic that
biotechnololgy will improve our way...
In its first progress report since adopting the EU strategy on life
sciences and biotechnology in 2002, the European Commission
yesterday indicated that the risk of diverging policies in Member
States could seriously hamper the effectiveness...