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...
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.
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.
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...
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...
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.
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 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.
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),...
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
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.