A potential new law mandating the running of clinical trials before
a "generic" biologic drug approval may seem like a potential
goldmine for contract research organisations (CROs), however, this
vision is premature.
The French Parliament has adopted legislation which prevents
biosimilar medicinal products from being classed as generics and
bans the automatic substitution of one biological medicine for
another.
This week Lonza took over the reigns of two new US business units
from Cambrex after completing the largest acquisition in its
company history and also announced a capability expansion at its
Czech Republic site.
Contract manufacturer Lonza has completed its acquisition of two
Cambrex subsidiaries, research bioproducts and microbial
biopharmaceutical, in a move that is fuelled by its strategic move
into biopharmaceuticals.
US Democrats spearheaded by Henry Waxman intend to re-table a
stalled piece of legislation that would allow US Food and Drug
Administration (FDA) approval of generic biodrugs, which they claim
would result in cost savings for patients...
US-based firm Xcellerex yesterday announced it has completed the
second half of a $20m (€15.4m) financing deal, raising $11m to
speed up commercialisation of its innovative disposable
manufacturing technology for vaccines and biotherapeutics.
Swiss chemicals firm and contract manufacturer Lonza has announced
18 per cent rise in net profit in 2006 rising to CHF 222m (€137.4),
fuelled by its strategic move into biopharmaceuticals.
India's Dishman Pharmaceuticals & Chemicals is planning to snap
up biotech and nanotech contract research organisation (CRO)
companies in Europe and in the US within drug conjugates to expand
their biologics capability.
The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.
Sigma-Aldrich Group member SAFC made its presence felt at the
recent CPhI in Paris with announcements regarding its expansion
activities in transgenic manufacturing and India.
The European Commission continues to be accused by European
industry of pushing 'green policies' that are stifling progress and
global competitiveness - the controversial REACH chemicals
legislation remains a sore point.
MedImmune has embarked on an expansion of its biologics
manufacturing facility in Frederick, Maryland, to ramp up its cell
culture production capacity, as several of its monoclonal
antibodies (MAbs) approach commercialisation.
Nabi Biopharmaceuticals has obtained the exclusive rights to use a
plasma protein purification technology from ProMetic Life Sciences
in the large-scale development and manufacture of its hyperimmune
products, cutting production costs...
The European Union (EU) has been criticised for being more
favourable to big biotech companies, at the expense of smaller
firms, according to consultants within the industry.
As the bio-outsourcing market hits boom time, the number of
contract biomanufacturing organisations (CBMOs) that specialise in
the production of biopharma products, is rapidly expanding.
Drug giant Eli Lilly has joined forces with Suven Life Sciences in
a deal that will focus on pre-clinical research of molecules in the
therapeutic area of central nervous system (CNS) disorders.
Seattle drug firm ZymoGenetics has taken Bristol-Myers Squibb (BMS)
to court for infringement of its fusion protein technology patents
by several products, including arthritis medication Orencia
(abatacept).
Spurred on by the frustration of drug manufacturers, governors from
four US states have petitioned the US Food and Drug Administration
(FDA) for clarity in their requirements for the production of
generic versions of insulin and human...
In an incident that state and federal environmental regulators are
treating as "serious," Merck released 25 gallons of a
cyanide-containing chemical from its West Point facility in
Pennsylvania to the sewer, killing hundreds...
As demand for protein-based drugs increases, Pall has introduced a
new type of mixed-mode chromatography sorbents that make protein
purification faster and cheaper.
Life sciences firm Cambrex has agreed a contract for the production
of clinical trial quantities of Merrimack Pharmaceuticals'
recombinant immunomodulatory serum protein, as its experience in
the downstream purification of proteins...
A new drug discovery technique, which uses mixed-mode sorbents in
process chromatography, has the potential to significantly reduce
costs and environmental burdens, especially in the protein
purification process.
Swiss biopharmaceutical firm Biopartners has got the thumbs up from
the European Commission for its biosimilar drug Valtropin, making
it only the second biogeneric drug to have been approved in Europe
after Sandoz's Omnitrope...
In its second acquisition in less than a month, Millipore has
acquired bioprocessing products firm Serologicals for around $1.4bn
(€1bn) in cash, as it tries to boost its growth by expanding in
potentially lucrative market segments.
As the threat of new viruses like avian influenza have heightened
the need for greater speed and safety in vaccine production, single
use technologies are proving far more safe and economic than
traditional cleaning techniques, according...
Thanks to a £2.7m (€3.9m) access fund from the UK's National
Biomanufacturing Centre (NBC), biotech firm Onyvax has hired
contract manufacturer organisation (CMO) Eden Biodesign to supply
it with clinical current good manufacturing...
Nilfisk used Interphex, New York, to showcase its new vacuum
designed to collect sub-micron particles and bring the cleanliness
and hygiene standards required in cleanrooms into a compact
machine.
Responding to surging demand for its flu drug Tamiflu, Roche has
announced it is expanding its external contractors to fifteen in
nine different countries, as its needs for intermediates and
finished product increase.
Filtration systems specialist Pall's net profit barely moved in Q2
compared to the similar period last year, up only $400,000
(€331,328) to $32.4m, still its Biopharmaceuticals business, driven
by a steady demand in consumables,...
Kreatech has launched the first complete miRNA isolation and
labelling kit, which combines the upstream isolation of small RNA
and the reagents necessary to label these DNA samples for
microarray analysis, offering a more complete...
Swiss custom manufacturing firm Lonza has entered into a joint
venture with investment management company Bio*One Capital to built
a $250m (€210m) large-scale mammalian cell culture plant in
Singapore, underlying Lonza's confidence...
A new laboratory method for distinguishing pathogens from harmless
relatives has been developed by scientists in the US. The
high-throughput technique will enable the quick identification of
pathogens, which could be used for bioterror...
Life sciences firm Cambrex has reported a $140.3m (€116.7m) loss in
Q4 as opposed to a profit of $4.9m in Q4 last year, hit by lower
long-term profitability projections for its Biopharma unit, as
biotech companies seem to lose their...
GE Healthcare has announced the introduction of Ettan nanoLC, a
fully bio-inert, robust, nanoscale peptide separation system that
delivers highly reproducible performance and is ideal for 1D-liquid
chromatography (LC) proteomics applications...
French firms PCAS and Proteus have decided to pool their expertise
to create a new biotech company which will provide APIs and
intermediates on a large scale, looking to offer new products and
also capitalise on the growing demand...
A new easy-to-use laser microdissection system from Olympus is set
to shake up the isolation technology market by reducing sample
handling and contamination when isolating cells for downstream
analysis and making the process routine.
Oxygen therapeutics company Biopure has announced another $3
million (€2.5 million) public offering to boost its working
capital, despite its major drug for humans, Hemopure, an artificial
blood product, being licensed only in South...
MiraiBio has released software for the statistical analysis of
multiplexed data generated on its liquid array detection system, a
platform that is designed for immunoassay, enzyme function, and
receptor-ligand interaction applications,...
Invitrogen has created three new business divisions in a move to
strengthen its position in the growing biotechnology industry and
drive growth through improving links between its product
development cycle and customer base.
Gentra Systems has introduced its new versaGene DNA Cell
Purification Kit, which responds to the growing need for
high-quality DNA for sensitive downstream applications. The kit
uses chemistry and column design to purify DNA with...
Doctors and cancer researchers have pleaded with EU politicians to
support a strong REACH chemicals regulation in order to halt an
increase in cancer rates, congenital malformations and asthma.
GE Healthcare has recently launched a number of diverse and
transformational medical technologies aimed at improving
productivity across the pharmaceutical manufacturing sector.
Arsenal Capital Partners has acquired a majority stake in Reilly
Industries for €209 million and Velsicol Chemical for an
undisclosed fee. The purchases continue a rich vein of activity for
the private equity firm, which now hold...
Drug packaging maker West Pharmaceutical Services release its 3Q
results, which indicate a rise in profits but fell short of analyst
estimates, due to slow sales in some segments and high raw material
and energy costs.
