New legislation on the good manufacturing practice (GMP) of
pharmaceutical excipients in Europe, which could complicate the
quality control of imports of excipients to the EU and make it
unattractive for some vendors to remain in...
The European Union has approved new alternatives to animal testing
of drugs and chemicals, which will not only reduce the number of
animals needed for testing, but will also increase the accuracy of
the tests, thereby making the products...
Asia is emerging as a hot spot for low-cost medical device
manufacturing as European drug companies pursue outsourcing options
or relocate production to cut costs. This increasing Asian
competition is alarming for European medical...
Japanese health care firm Eisai will make Hatfield its European
headquarters, in a major £75 million (€105 million) investment that
demonstrates the UK's appeal for big pharmaceutical companies.
Baxa has announced it is to move to direct sales and marketing
operations in Europe, bringing to an end its existing business
strategy, which sold its products through exclusive distributors,
with support provided by Baxa from their...
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.
Catch-up legislation from the EU has swept away the handicap on
European generics companies, allowing them to research copycat
drugs before patent expiry.
Doctors and cancer researchers have pleaded with EU politicians to
support a strong REACH chemicals regulation in order to halt an
increase in cancer rates, congenital malformations and asthma.
EU environment ministers met on Monday to further debate key issues
related to the chemical substances review, which has become one of
the fiercest political battlegrounds ever in the history of EU
policy definition.
Life sciences is to be given priority under a European Commission
(EU) framework, which focuses on creating a knowledge-based economy
to ensure increased funding for this industry.
Sweden's Biotage, a specialist in microwave synthesis and
chromatography systems for drug development and production, has
taken some of its European distribution into its own hands through
the purchase of Separtis Holding.
Sun Pharmaceutical Industries has become the second Indian
drugmaker in a matter of days to announce the purchase of a
manufacturing facility in Eastern Europe that will serve as a
springboard for expansion into the broader European...
The rapporteur trying to finesse the controversial REACH
legislation through the European Parliament, Guido Sacconi, has
formulated a compromise that aims to alleviate fears that the
regulations could pose a heavy financial burden...
A recent study designed to assess biopharmaceutical innovation in
the member states of the Organisation for Economic Cooperation and
Development has found that, in terms of innovation and
biotechnology industry development, Belgium...
The UK's figures on recycling waste is skewed because companies are
exporting their problem rather than increasing reprocessing rates,
the UK's second largest packaging waste compliance company claims.
The European Medicines Agency (EMEA) has finalised a new procedure
designed to make the process for the development, consultation,
finalisation and implementation of pharmaceutical guidelines
clearer.
The European Union has started a research project, backed with €7
million, to develop high barrier polymer films using nanocomposites
for a broad range of packaging and other industrial applications.
Croatian pharmaceutical company Pliva has won its first European
approval for generic erythropoietin, a biologic drug used for the
treatment of low red blood cell counts, reports Phil Taylor.
AstraZeneca has been fined a hefty €60 million by the European
Commission for manipulating patent laws to keep competitors out of
the market, marking the first occasion that antirust laws have been
used to combat patent abuse.
The European commission came under heavy criticism after rheumatism
was not recognised as a major disease group in its research and
biomedical programme - an outrage, according to The European League
against Rheumatism (EULAR).
Sanitas, Lithuania's largest pharmaceutical producer, signed an
agreement in late May to purchase Hoechst-Biotika, a drug
manufacturer in the Slovak Republic.
The European pharmaceutical sector is falling behind the US in
terms of innovation and R&D expenditure and is increasingly
under threat from newcomers, especially in India and China.
The European Union is to part-finance the creation of a European
Theoretical Spectroscopy Facility (ETSF) to advance collaboration
across the continent in the field of nanotechnology, reports
Phil Taylor.
Norbrook Laboratories of Northern Ireland has acquired two
anaesthetic product lines and a production facility from Czech
company Synthesia, part of the Aliachem group, reports Phil
Taylor.
The European Centre for the Validation of Alternative Methods
(ECVAM), part of the Joint Research Centre (JRC), is seeking to
reduce animal testing as part of the upcoming EU directive that
aims to abolish animal testing in scientific...
A recently-launched project by the European Union is aiming to
demonstrate once and for all whether nanoparticles - which underpin
the emerging discipline of nanotechnology - are safe, reports
Phil Taylor.
The European Generic Medicines Association has criticised proposals
by the European Commission to offer six months' additional patent
protection to companies conducting trials of their drug products in
children.
Europe is set to fall further behind in the development of novel
anti-cancer agents unless it doubles the amount spent on academic
clinical trials. New and more effective non-drug interventions and
prognostic markers depend on these...
In France, sales of generic drugs are continuing to grow, helped by
a favourable regulatory regime and a wave of patent expiries on top
branded drugs, reports Phil Taylor.
Commercial League, the largest and fastest-growing pharmaceutical
group in the Balkans, has opened a new primary and secondary
packaging plant in Bulgaria to serve the domestic and, potentially,
export markets.
Teva Hungary, a subsidiary of number two generic company Teva
Pharmaceuticals, is to build a $100 million (€75m) factory for the
production of active pharmaceutical ingredients (APIs) in
Sajobabony, Hungary.
New statistics released today show that total US investments in
R&D made by the biotechnology and pharmaceutical industry
topped $38.8 billion (€29.3 billion) during 2004. This beats the
$34.5 billion total set in 2003 and demonstrates...
The pharmaceutical and biotechnology industries in the 'new' EU
countries are rapidly expanding, presenting considerable potential,
although parallel imports remain a challenge.
A €10 million grant from the EU has allowed researchers throughout
Europe to advance their research in the field of 'biological
crystallography,' which aims to create precise, 3-D "architectural"
models of biological...
The pharmaceuticals sector has been highlighted by the UK
government's Cabinet Office as one of its priority projects in a
review of business regulation.
Hungary's Richter Gedeon reported rises in both overall sales and
profits in 2004, although its active pharmaceutical ingredient
(API) business remained under pressure in the US.
Three chemicals companies - Akzo Nobel, the Hoechst unit of
Sanofi-Aventis and Total subsidiary Arkema - have been fined €217
million by the European Commission for operating a cartel in the
market for monochloroacetic acid (MCAA).
The European Parliament embarked on a new round of deliberations
over the controversial REACH legislation last week, amid intense
lobbying by groups representing the chemicals industry, animal
rights activists and environmentalists.
The market for low-cost generic drugs looks set to be buoyant for
the foreseeable future, both in Europe as a whole and in France,
according to Hubert Olivier, president of the French subsidiary of
the leading German generics group...
Judith Hackitt, director general of the UK Chemical Industries
Association, highlighted the key issues facing the UK sector at a
the group's recent council meeting in London.
The Ministry of Commerce in China has that it plans to review the
five-year programme of anti-dumping duties it set on catechol
imports from the European Union.
A study into the price of orphan drugs in the EU revealed that
access to treatments for patients with rare disorders can vary by
as much as 70 per cent within individual EU member states.
European contract manufacturers of active pharmaceutical
ingredients (APIs) are operating under a system of regulatory
double standards that is destroying their ability to compete in the
marketplace.
A joint proposal by the UK and Hungarian governments that would
allow chemical companies to share the cost of testing to comply
with the new REACH legislation has received the support of the
European Union's Competitiveness Council.
Avery Dennison, one of the world's largest suppliers of pressure
sensitive adhesive labels, is expecting to be fined by the European
Commission for what it describes as 'instances of improper conduct'
by workers in...
The growing loss of patent protection on blockbuster drugs over the
next few years and the rising need to contain spiralling healthcare
costs are going to lend significant impetus to the growth of
Europe's generics and biogenerics...
Franz Humer, president of the European Federation of Pharmaceutical
Industries and Associations and chief executive of Roche, has
issued a plea for a concerted effort at improving Europe's science
base at the European Parliament.
The European Commission has published details of a new proposed
regulation aimed at stimulating research into drugs for use in
diseases affecting children.
LGC, the independent analytical laboratory, has set up an
initiative alongside the UK Chemical Industries Association (CIA)
to advise chemical companies how to handle the new REACH
legislation.
The latest study to lament the cost of implementing the European
Union's REACH system has predicted dire consequences for the EU's
Gross Domestic Product, production base and innovative strength.
