As of next year Chinese pharmaceutical manufacturers will face a
tougher time gaining good manufacturing practice (GMP)
certification after the country's regulator signalled new and
stricter standards were on the way.
In another safety concern over a long-approved drug, Roche has been
forced to add new warnings to its anti-transplant rejection drug
CellCept (mycophenolate mofetil (MMF)) amid the news that it is
associated with increased risk of...
Roche heard early this morning that the European Commission (EC)
has decided to reinstate the marketing authorisation for the
company's HIV drug, Viracept (nelfinavir), but countries outside
the EU have yet to make a final decision.
Following the recent news that pharma heavyweight Pfizer has also
been struck by contamination of its HIV drug Viracept (nelfinavir),
in-PharmaTechnologist.com spoke to the US Food and Drug
Administration (FDA) to find out how far...
Sanofi-Aventis' hotly touted anti-obesity blockbuster drug has
become weighted down in safety concerns as the French company
withdraws its New Drug Application (NDA) in the US and awaits a
safety review in the EU.
UK drug delivery and orthopaedic devices company The Medical House
(TMH) is entering the second phase of a development project for a
European defence agency involving its AutoSafety Injector (ASI)
disposable autoinjector technology...
MDS pharma has ceased operations at its bioanalytical services
facility in Blainville, Quebec in a bid to boost profitability
after an ongoing investigation of the site by the US Food and Drug
Pharma companies that aren't maximising their outsourcing potential
in clinical research may be wasting a world of opportunity.
OutsourcingPharma.com gives a brief run down of exactly what kinds
of services and providers are...
For pharma companies that are hesitant about outsourcing during the
drug discovery stage, a world of opportunity awaits.
OutsourcingPharma.com gives a brief run down of what kinds of
services are on offer, as well as a few potential...
The number of new drug submissions has halved since 1995, while at
the same time, pharma companies are spending three times as much
money on R&D - a hole this industry needs to dig itself out of,
Elsevier have launched a drug tracking and analysis tool that is
set to greatly benefit laboratory researchers working in the
pharmaceutical and biotech professionals by bringing together drug
characteristics and status within a database.
Indian drug maker Shasun Chemicals & Drugs has agreed to buy
the customs synthesis business of French company Rhodia Pharma
Solutions, in a move to strengthen its global presence in active
pharmaceutical ingredient (API), custom...
Researchers have claimed that a new microchip could cut animal
testing in the pharmaceutical industry as well as speed up drug
development. By increasing the efficiency of preclinical testing of
new drugs the new chip is also set...
An official of the Food and Drug Administration (FDA) has admitted
that the regulatory agency was "the single greatest obstacle to
doing anything effective" regarding Vioxx, adding that the FDA
could have prevented the...
West Pharmaceutical Services, fresh from the disposal of its drug
delivery business, is to acquire Monarch Analytical Laboratories in
exchange for cash, assumed liabilities and shares totalling $5.6
A new type of antidepressant drug with a novel mechanism of action,
which acts on a new target, has entered Phase I clinical trials.
The drug could represent a new generation of psycho-active
compounds that are devoid of the problems...
The merger between Yamanouchi and Fujisawa is the first step
towards creating a global mega-player, but additional tie-ups will
be required if the new entity is to join the top tier of
multinational pharmaceutical companies.
In Russia, the Health Ministry suspended the licences of 321
companies manufacturing or trading in counterfeit medicines last
year, and a further 200 may also lose their licences following
ongoing investigations, according to the...
The US Food and Drug Administration (FDA) yesterday issued a new
document that encourages drug and biologic developers to conduct
pharmacogenomic tests during drug development and clarifies how the
agency will evaluate the resulting...
Netherlands-based drugs, coatings and chemical maker Akzo Nobel has
announced a €500 million divestment program and suggested that it
is unlikely to remain a player in all three of these sectors in the