For the past 10 years, drug companies have paid the US Food and
Drug Administration (FDA) fees to review each drug they want
approved, on the grounds that the increased funding for the agency
would accelerate review times and shorten...
A UK-based animal rights group has passed video footage of alleged
animal cruelty at a facility in Germany run by US contract research
company Covance to the Ministry of Environment in
Northrhine-Westfalia.
In response to growing concerns about counterfeit drugs in the US
drug supply, an industry group has submitted a report to the Food
and Drug Administration (FDA) as a commentary on policy issues
surrounding prescription drug counterfeiting,...
Mark McClellan, the US Food and Drug Administration Commissioner,
has given the strongest hint to date that generic versions of
biological drugs may be approved without the need for extensive
clinical trials.
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
through mail-order.
Companies filing for approval of their drugs in the US market must
now supply all information on the product's labelling and package
insert in an electronic format, according to the Food and Drug
Administration (FDA).
Bar code scanning systems, which scan medications and patient
identification bracelets at hospital bedsides to verify patients
are receiving the correct medications, were voted the top choice
for preventing medication errors in a...
The US authorities have arrested another individual for suspected
involvement in the distribution of fake copies of Pfizer's
blockbuster cholesterol-lowering drug Lipitor (atorvastatin).
The pharmaceutical industry has welcomed the passage of new
legislation by the UK Parliament that will give police new powers
to intervene in public order offences, including those carried out
by animal extremist groups.
Three individuals have been formally charged in the US for their
alleged involvement in the counterfeiting of Pfizer's Lipitor
(atorvastatin) as investigators try to unravel the intricate web of
conspirators behind the case.
New legislation in the US to give the elderly and disabled rights
to reimbursement for prescription drugs under the federal Medicare
system has been passed by the Senate. It has been estimated that
the measure could expand the revenues...
The European Parliament's Environment Committee takes a vote
tomorrow on the review of the EU medicinal product directive, set
to define the boundary between dietary supplements and
pharmaceuticals. Europe's pharmaceutical...
The US has passed a new bill that will see the country invest €3.1
billion in nanotechnology over the next four years and should
cement its position as a leader in this emerging technology sector.
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
