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.
Caliper Technologies has announced its intention to acquire
laboratory automation, liquid handling and robotics specialist
Zymark in a deal valued at around $71 million in cash and stock.
Germany's Chiracon, a specialist in novel raw and starting
materials for high-value pharmaceuticals, has joined the circle of
Startup-Partners, the central capital marketing agency for Berlin.
Sam Waksal, the disgraced former chief executive of US
biotechnology company ImClone Systems, is due for sentencing today
and could receive a jail sentence as well as significant fines.
The UK's Medicines and Healthcare products Regulatory Agency has
asked for prescribing restrictions on GlaxoSmithKline's
widely-prescribed antidepressant Seroxat.
Owens-Illinois has launched a line of child-resistant 'squeeze and
turn' packages that incorporate a closure and bottle system
suitable for solid oral dose uses
Isis Pharmaceuticals and Eli Lilly say they have reached a mutually
beneficial renegotiation of their manufacturing relationship for
cancer drug Affinitak
Millennium Pharmaceuticals has said that it plans to cut around 600
jobs and wind down some of its manufacturing operations as it seeks
to reach profitability by 2006
Nature Technology has launched an improved delivery technology for
DNA vaccines that is now available for license by companies working
in this fast-growing area
ICOS has entered into a biologics manufacturing agreement with Eli
Lilly, in which the Bothell, Washington-based firm will manufacture
two clinical candidates
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.
Patheon Italia has extended its manufacturing services agreement
with Roche to continue to supply the Swiss firm with solid, liquid
and sterile products for the European market.
Transgenomic has taken out a non-exclusive licence from Geron in
which it gains manufacturing rights to phosphoramidate and
thio-phosphoramidate oligonucleotides.
Boston Biomedica has been issued an additional US patent covering
the design and use of its Pressure Cycling Technology for the
control of pressure-sensitive chemical reactions.
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.
West Pharmaceutical Services is rolling out its Westar RS
sterilized component service, formerly only available from its US
facilities, at sites in France, Germany and Singapore.
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.
Xenova of the UK has been awarded a two-year contract by Sweden's
Pharmexa for the manufacture of a vaccine in clinical trials as a
treatment for breast cancer and other tumours.
Schroder Ventures Life Sciences has raised $402 million (€344m) for
its biotechnology investment fund, providing a signal that venture
capital may at last be turning its head back in the direction of
the sector.
METabolic EXplorer, a French biotechnology company specialising in
the development and production of new biological processes for the
manufacturing of chemicals and pharmaceuticals, has bolstered its
scientific team with the appointment...
Baxter Healthcare of the US says it is planning a seven-year, $100
million (€85m) expansion of its parenteral contract manufacturing
services for pharma and biotech companies.
Trident has launched a new ink jet printing system, called
SolidJet, that is specially designed to print packaging for
pharmaceutical, food and beverage, and personal care products.
Swiss chemicals group Lonza has said that a new small-scale
production plant at its Visp site will come on stream in July and
will boost its services in the area of exclusive manufacturing of
pharmaceutical products.
GEA Filtration has introduced a microfiltration plant for the
PharmaChem industries that, it claims, can perform studies on the
full range of filtration technologies using all types of filter
membrane.
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.
UK-based packaging company Rexam has reached an agreement to
acquire all the shares of Risdon Pharma Development, a plastic
pharmaceutical packaging business, for €125 million in cash.
Cambrex has initiated a project aimed at constructing a new
facility to accommodate four cGMP-compliant suites dedicated to
cell therapy manufacturing. The company said the expansion would
increase its manufacturing capacity by 100...
Just over a year after acquiring the FSG business from Vivendi for
$360 million (€307m), Pall Corp has reported a healthy hike in
fiscal third-quarter sales and profits and once again raised its
earnings forecast for 2003.
Akzo Nobel's Diosynth unit has signed a multi-year contract to
manufacture and supply the active pharmaceutical ingredient for
Pfizer's growth hormone receptor antagonist Somavert. The value of
the agreement was not disclosed,...
AstraZeneca has opened a new multi-million dollar research facility
in Bangalore, India, which will focus principally on finding new
treatments for tuberculosis, a disease which is diagnosed in about
8 million people worldwide each...
Aldo Magnini has been appointed managing director of Clariant's
pharmaceuticals ingredients manufacturing business in Italy, based
around the company's two manufacturing plants in Origgio and Isso.
Dutch firm Crucell has expanded its licensing agreement with US
drug major Merck & Co relating to PER.C6, the former's
proprietary cell technology platform used for the production of
biopharmaceutical products.
Japanese drugmaker Eisai is planning to double the production
capacity for its two top-selling drugs - Pariet and Aricept - by
2004, with an investment of ¥9 billion (€65m).
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.
Germany-based drugmaker Merck KGaA has launched a major
restructuring of its R&D activities after shelving two of its
early-stage diabetes product candidates, EML 16336 and IDD 676.
Ireland's QUMAS has said it will launch its latest regulatory
compliance product, QUMAS Visa, at the 39th Annual Meeting of the
Drug Information Association in San Antonio, Texas, 15-19 June.
One of Pfizer Global R&D's major research facilities, based in
Nerviano, Italy, has signed an expanded agreement with PerkinElmer
in which the latter will provide repair, maintenance and validation
services for sophisticated...
A science and technology advisory group has called on the Irish
government to ensure that the country remains competitive in the
pharmaceutical and chemical industries by developing R&D
operations and, in particular, fostering...
The European Commission has published a draft monograph in the
European Pharmacopoeia for BASF's recently-introduced
sustained-release coating polymer Kollicoat SR 30 D and a modified
monograph for Kollicoat MAE 30 DP.
UK firm Cobra Bio-Manufacturing has announced its intention to
undertake a placing and open offer to raise £4.65 million (€6.45m)
to fund the purchase of an additional manufacturing plant in
Cowley, Oxford.
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...
UK company SkyePharma is expecting to achieve turnover of £100
million (€139m) in 2003, which would represent a rise of around 40
per cent over last year. However, the company has warned that the
lion's share of this total would...
Reports in Ireland have suggested that Germany's Schwarz Pharma is
planning to scale back its operations in Shannon and cut its
workforce. The company is allegedly planning to reduce its Irish
workforce by 70 to around 180 staff.
US biopharmaceutical firm Acceptys has licensed an immortal
humanised cell line from Columbia University, which will allow it
to discover and produce fully human monoclonal antibodies and other
human proteins for use as therapeutic...
Speciality chemical company Rohm and Haas has created a new
business unit, Advanced Biosciences, that specialises in the
production and purification of biopharmaceuticals. The new unit is
well placed to address the shortfall in production...
The European Commission has given the go-ahead for Germany to grant
a proposed €78 million in aid to help Merck KGaA build a new
biopharmaceuticals plant for the production of oncology products in
Jena, Thuringen.
Switzerland's Solvias AG, a specialist in scientific and technical
services and products based on synthesis and analysis, has reported
a healthy 20 per cent hike in 2002 sales to SF43.6 million
(€28.6m). The increase was driven...
US pharmaceutical major Eli Lilly has earmarked a hefty £220
million (€304 million) investment over the next four years in its
UK facilities, representing the largest investment by the firm in
any European country.
