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.
European scientists continue to be strong in areas such as medical
research and chemistry and Europe may produce the highest number of
science graduates but it is lagging behind in biotechnology, still
employs fewer researchers, accounts...
The European Commission has given Pfizer the all clear to acquire
Pharmacia corporation - paving the way for the creation of the
largest pharmaceutical company in the world.
The US Food and Drug Administration announced this week that it has
accomplished the initial objectives outlined in its ongoing
initiative to modernise the agency's regulation of pharmaceutical
manufacturing and product quality.
US company Mylan Laboratories has reached a final agreement with
Bristol-Myers Squibb, which resolves all disputes between the
companies related to buspirone.
AstraZeneca Canada has received approval from the Therapeutic
Products Directorate of Health Canada to market CRESTOR
(rosuvastatin) 10 to 40 mg, a new medicine for the management of
primary high cholesterol (primary hypercholesterolemia),...
Cognis Nutrition & Health, a nutritional ingredients supplier,
has responded to claims made earlier this week by Dutch rival
Loders Croklaan regarding the infringement of several of its
patents.
Swiss pharmaceuticals company Roche yesterday said its vitamins and
fine chemicals unit, recently sold to DSM, fully complies with new
requirements for vitamin E issued this month by the Netherlands.
US company Biolog this week received a patent for its Phenotype
MicroArray technology. The patent, number US 6,472,201, is granted
for comparative phenotypic analysis of two or more microorganisms
using a number of substrates within...
In response to recent news regarding patent litigation surrounding
its drug ribavirin, biopharmaceutical company Ribapharm announced
this week that it believes its patent position to be unchanged by
Schering-Plough's recent action...
High Content Screening company Cellomics announced today that the
Canadian Intellectual Property Office has issued Cellomics'
Canadian Patent No. 2,328,194 entitled 'A System for Cell-Based
Screening.'
US Valentis announced that its wholly-owned subsidiary, PolyMASC
Pharmaceuticals, has received a favourable ruling from the Japanese
Patent Office in regard to patent invalidation proceedings brought
by ALZA Corporation, a unit of...
AAC Consulting Group, the regulatory consulting subsidiary of
contract research organisation Kendle International, has signed an
agreement with two toxicologists to further expand its services to
the food and dietary supplement industries.
