The Chinese State Food and Drug Administration (SFDA) has revealed
plans to tighten the drug registration review process as it
attempts to improve standards in the nation.
The opening of ORF Genetics' $1m production site for recombinant
proteins in Grindavik, Iceland, is yet another groundbreaking move
by this year's winner of the Icelandic Centre for Research's
innovation award.
IMS has identified 10 critical developments in 2007 that could have
a fundamental effect on the operating environment for
pharmaceutical companies in the coming years.
Switzerland-based Schweizerhall appears to have circumnavigated
patent law, with approval of its generic version of Bristol-Myers
Squibb's (BSM) and Sanofi-Aventis' Plavix (clopidogrel bisulfate)
in Germany "expected...
China is on course to having its own version of the International
Pharmaceutical Excipients Council - joining its fellow
organisations in Europe, the Americas and Japan.
Outsourcing-Pharma.com compiles the news that has featured in the
clinical contract community of late, involving Tigermed Consulting,
Lifetree Clinical Research, Synexus and Anapharm.
2005 marked the real beginning of contract manufacturing in Japan,
which had been held back by an overly-cautious regulatory
environment and significant and unique quality and specification
demands in the marketplace.
Agilent's purchase of DowPharma's Nucleic Acid Medicines business
is the second time in recent years that the US scientific
measurements specialist has ramped-up its nucleic acid
manufacturing capabilities.
Cambrex has experienced a jump in profitability for the first
quarter 2008, despite a decrease in sales, assisted by previous
cost-cutting initiatives.
The decision to end manufacturing operations at its facility in
Morgan Hill, California in the next three years may cost
Hospira up to $35m (€22.7m), according to a document the firm filed
with the US Securities and Exchange Commission...
Although Japan's pharma market sits in firm second position on the
global stage, the country's foothold is slipping as other more
innovative countries grasp for a greater presence.
Pfizer's plans for a new €190m manufacturing plant in Shanbally,
Ireland suggest that the firm is intent on fulfilling its pledge to
become a "top five biologics producer in the next eight
years."
Teva's sales of active pharmaceutical ingredients (APIs) for the
first quarter of 2008 rose by 51 per cent on the previous years
figure, taking to total to $510m.
Continued weakness in the market for products used in the
manufacture of biologic drugs was the main reason why Millipore
experienced a 'challenging' quarter, according to CEO Martin
Madaus.
UK-based Cambridge Consultants has developed a portable instrument
which it says could "revolutionise" the way airborne drug
delivery devices are tested.
GEA Pharma Systems believes that its new Performa P system, which
was presented at this year's Interpack conference in Dusseldorf,
Germany, can help increase output and reduce costs for tablet
manufacturers worldwide.
A heart medication sold by Mylan Laboratories in the US has had to
be recalled, after it emerged that some doses may contain twice the
intended dose of active ingredient.
The US Food and Drug Administration (FDA) has sent Merck & Co a
warning letter saying it has failed to correct a number of
manufacturing deficiencies at its main vaccine manufacturing plant
in West Point, Pennsylvania.
UK-based AM Technology has developed the Coflore Agitated Cell
Reactor (ACR) which it claims offers significant advantages over
traditional continuous stirred tank reactors.
The US Food and Drug Administration (FDA) has withdrawn its
long-standing block on the manufacture of new products at Watson
Pharmaceuticals' facility in Davie, Florida.
GlaxoSmithKline (GSK) has announced company-wide reorganisation
plans that will see it place a new focus on emerging markets in a
bid to capitalise on the growing potential they offer.
Swedish authorities have recalled Sanofi Aventis' low molecular
weight injectable blood thinner Lovenox (enoxaparin), known locally
as Klexane, after four batches of the blockbuster drug were found
to contain oversulfated chondroitin...
India's Dr Reddy's Laboratories has just announced the signing of a
definitive agreement to buy the US pharmaceutical contract
manufacturing business of chemicals giant BASF.
A new type of latex glove developed by Yulex Corp that is less
allergenic for medical and research staff has been given a green
light by the US Food and Drug Administration (FDA).
UK researchers have started developing a 'lung in a test tube',
that could aid research into respiratory diseases such as asthma
and allergy and reduce the need for animal testing.
US-based BioDuro and The National Center for Safety Evaluation of
Drugs (NCSED) in Beijing have received full accreditation from the
Association for Assessment and Accreditation of Laboratory Animal
Care International (AAALAC).
Dutch chemical group DSM has acquired Polymer Technology Group
(PTG) and predicted its best financial year to date following
organic sales growth of 14 per cent for the first quarter.
In this week's review of activity within the preclinical research
services arena, news has emerged involving MIR Preclinical
Services, Commonwealth Biotechnologies and Innogenetics.
Lab901 has raised £3.5m in funding, which will go towards expanding
its sales efforts and new products for RNA and Protein
Electrophoresis - a market that is currently worth $1.3bn worldwide
and expected to increase to over $1.6bn.
Invitrogen's first-quarter profits were nearly double those it
recorded in the first-quarter of 2007.The maker of kits used for
cloning enjoyed growth, driven by sharp increases in sales for drug
discovery and research.
Quintiles Transnational has heralded the results of an
independently conducted study of clinical investigator sites across
Europe that saw the firm rate the highest overall in terms of
satisfaction.
ELGA Process Water has launched its new All-in-Pack water treatment
solution for pharmaceutical manufacturers wishing to reduce both
capital expenditure and associated running costs.
Outsourcing-Pharma.com compiles the news that has featured in the
clinical contract community of late, involving eResearchTechnology
and nSpire Health, i3 Research and Clinsys Clinical Research.
German-based technology group Schott has formed a joint venture
with Kaisha in an attempt to gain access to the glass primary
pharmaceutical packaging market in India.
The healthcare logistics industry is currently experiencing a shift
toward globalisation, supply chain simplification and delivery
specialisation, says an industry expert.
US drugmaker Unigene has begun construction of new facilities in
China as part of its joint venture with a state-owned Chinese
pharmaceutical company to establish research, development and
manufacturing capacities in the nation.
Three Indian contract research organisations (CROs) - Asian
Clinical Trials (ACT), Veeda Clinical Research and Siro Clinpharm
have made recent global moves in order to add more muscle to their
industry presence.
The Bio Affinity Company (BAC) has introduced two new products for
scientists who need to purify hard-to-separate antibodies such as
immunogloblins A and M.
The US Food and Drug Administration (FDA) has revealed evidence
linking the heparin contaminant with the series of reported adverse
reactions, and has also now issued a warning letter to the Chinese
facility at the centre of the safety...