Legislation drives Kyorin investment
Japan's Kyorin Pharmaceuticals has revealed that it will build a
new formulation plant at its Noshiro facility in Akita prefecture,
in response to revision to the Pharmaceutical Affairs Law.
Swiss expansion for Ferring
Ferring Pharmaceuticals has unveiled plans to invest €90 million in
a state-of-the-art production site in Saint-Prex in Switzerland.
Big hitters bash biogenerics
An October conference on biogenerics will see research-based
biopharmaceutical companies and their generic rivals battle to win
the hearts and minds of regulators.
FDA plans to amend 21 CFR Part 11 rules
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...
GSK starts energy reduction programme
GlaxoSmithKline has enlisted the aid of the UK government in a
program aimed at reducing energy expenditures at six primary
Germany industry group slams reforms
The German government's health care system reform proposals cast
fundamental doubts over Germany's future as a research location,
says VFA chief.
Deal finally reached in WTO access talks
The World Trade Organisation's executive has finally broken
deadlock in a deal to give some of the world's poorest countries
access to cheap drugs.
UK relaxes salt/ester rules for generics
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.
German health reforms drive out Pfizer, Merck
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.
FP6 information day for biopharmaceutical SMEs
The emerging biopharmaceutical enterprises (EBE) group will hold an
information day on priority one of the Sixth Framework Programme on
Packaging case ends in victory for parallel traders
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
USA speeds generic approvals
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 follows suit on PPA ban
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.
EU updates excipient labelling guidance
The European Commission has updated its guidelines on the labelling
of excipients used in medicinal products and the manufacturing of
Harmonisation panel makes progress on CTD
International Conference on Harmonisation committee reports
progress being made on a number of fronts, including the common