The prospect of a prescription drug benefit for the elderly in the
US has led to share price hikes in Euro pharma companies; SG Cowen
analyses the impact.
Industry-backed group says UK should help support the country's
biotech companies by setting up a national agency to organise
clinical trials and boost companies' liquidity.
Japan is losing out competitively at the expense of its rivals in
the global pharmaceutical industry, says EFPIA, and must take steps
to improve the environment for drug companies.
Avecia has scored a world first with the certification by all
European Union member states of its DNA medicines production
facility at Grangemouth, Scotland.
The globalisation of the marketplace for pharmaceuticals means that
it is becoming more common for medicines destined for consumption
in the European Union to be manufactured in distant lands. As a
consequence, the EMEA has started...
The REACH framework for chemicals will contrary to the industry's
view, actually improve conditions for innovation in Europe,
according to EU Commissioner Erkki Liikanen.
AstraZeneca is roundly rebuked by The Lancet in an editorial that
describes the firm's development of its new cholesterol-lowering
drug Crestor as a "triumph of marketing over science".
The UK High Court has issued injunctions against a number of
individuals found to be involved in the harassment of staff working
for UK-based Japanese pharmaceutical companies.
The US FDA's task force on counterfeiting of drugs issued its
preliminary report on schedule at the end of last week, and said
that it would be preparing a final document for early in 2004.
BASF has started work on a combined heat and power plant at its
site in Ludwigshafen that will help the company meet its long-term
environmental targets.
The European Commission has stepped back from requiring the
industry to test thousands of chemicals already used and sold in
Europe, according to an environmental group.
An October conference on biogenerics will see research-based
biopharmaceutical companies and their generic rivals battle to win
the hearts and minds of regulators.
The US Food and Drug Administration has issued its final guidance
document describing its current thinking regarding the scope and
application of 21 CFR Part 11 on electronic records and electronic
signatures; also unveils a series...
The UK MHRA will allow salt and ester variants of active drugs to
be submitted for approval as generics using abridged applications,
following the EU's lead.
US pharmaceuticals major Pfizer is considering moving some of its
activities in Germany to the UK due to government health reforms;
meanwhile, Merck & Co has shelved plans to open a new R&D
facility in the country.
Parallel traders in pharmaceuticals fend off moves to force them to
use plain white boxes and black print in their packaging; they
argue that such a restriction could lead to patient safety
problems.
The pharmaceutical industry is facing the possibility of earlier
generic competition for its branded products from 18 August, when
new legislation in the USA comes into effect.
Japan's Ministry of Health, Labour and Welfare has ordered
companies to stop producing over-the-counter (OTC) pharmaceuticals
containing phenylpropanolamine (PPA), linked to an increased risk
of haemorrhagic stroke.
The European Commission has updated its guidelines on the labelling
of excipients used in medicinal products and the manufacturing of
investigational drugs.
Roche's Burgdorf plant making insulin pumps has serious regulatory
compliance problems, said the FDA, which could block import of the
products unless resolved.
BASF has put forwards environmental and safety standards that will
see it comfortably meet and exceed the pledges for greenhouse gas
emissions laid down by the Kyoto Protocol. The firm stresses the
need for a voluntary system of control,...
The European Commission has issued its long-awaited response to the
G10 Medicines Report, intended as a blueprint for improving the
European pharmaceutical industry's competitiveness while ensuring
high levels of public health...
A conference on 1 July will provide an update on the UK Medicines
and Healthcare products Regulatory Agency Best Practice Guidance on
the Labelling and Packaging of Medicines
While the procedure for designating drugs for orphan diseases has
improved dramatically in the EU, further progress must be made,
says EU biotech group
The UK has launched a new study to examine in detail the benefits
and risks of nanotechnology and make sure that any necessary
regulatory framework is in place early on
As regulators increase their scrutiny of manufacturing and quality
control, the key to avoiding non-compliance notices lies in
well-trained, knowledgeable personnel, says new report.
Pharmaceutical company mergers and acquisitions plus industry-wide
cost cutting has squeezed investment into manufacturing, which may
lead to GMP non-compliance and fines, warns a new report.
The UK BioIndustry Association has serious concerns that the EU
Clinical Trials Directive could have a negative impact on the
attractiveness of the UK as a location for clinical research.
Schering-Plough has reached an agreement with the US Food and Drug
Administration to correct the firm's manufacturing compliance
problems, which led to a $500 million fine last year.
The UK Department of Trade and Industry has commissioned a new
programme, called Measurements for Biotechnology, designed to
develop and share good practice in bioanalytical methodology.
The European Union's Employment, Social Policy, Health and Consumer
Affairs Council agreed on 2 June not to press ahead with proposals
to implement a mandatory centralised marketing authorisation scheme
for all medicines.
The European Federation of Pharmaceutical Industries and
Associations has called for the European Commission to set up a
more favourable legal framework to help the region's pharmaceutical
industry compete with its peers in the...
Drug delivery company Atrix Laboratories confirmed this week that
the German regulatory authority, Bundesinstitut fur Arzneimittel
und Medizinprodukte (BfArM), had recently completed a successful
inspection of Atrix's manufacturing...
The proposed sale of Roche vitamins to Dutch firm DSM is to go
through second phase merger investigations by the European
Commission due to competition concerns in the feed enzymes market.
European Commission publishes table detailing progress it has made
in negotiating Protocols to the Europe Agreements on Conformity
Assessment and Acceptance of Industrial Products (PECAs) with a
number of accession countries.
Patient safety, care quality, and efficiency in the supply chain
are likely to improve with new proposals from the US Food and Drug
Administration (FDA) that will require bar coding on medications.
