Procter & Gamble (P&G) has announced its intention to
outsource the active pharmaceutical ingredient (API) R&D and
manufacturing work undertaken at one of its US factories, with
resultant closure of the site and job losses.
A European regulatory committee has recommended the approval of
three generic versions of Johnson & Johnson's (J&J) anaemia
blockbuster Eprex in what could lead to the market launch of new
"biosimilars" by the...
Roche has committed hundreds of millions of dollars to an
early-phase rheumatoid arthritis drug, a move that is indicative of
big pharma's increasing tendency to license earlier phase
compounds.
At a time when single-use manufacturing equipment is riding on a
surge of popularity, in-PharmaTechnologist.com talks to Vijay Singh
of GE Healthcare's newly acquired Wave Biotech unit about the
impact disposables will have on...
BioFocus DPI has released a new informatics system that can combine
chemical and biological data from various sources to optimise
protein kinase inhibitor candidate selection.
This year's American Society for Clinical Oncology (ASCO)
conference is over and as 45,000 scientists head home,
DrugResearcher.com looks at some of the most innovative drugs that
were on show.
The apparent inability of current analytical techniques to fully
characterise complex biological drugs still stands in the way of
easy approval pathways for 'biogenerics' or copies of off-patent
brand name biologics.
Just weeks after announcing intentions to snap up biologics firm
MedImmune, AstraZeneca has acquired DSM's old biologics
manufacturing facility in Montreal, Canada, a site that's been
gathering dust since it was mothballed...
UK biotech firm Acambis has decided to bring the manufacturing of
its soon to be approved smallpox vaccine in-house while its
agreement with contract manufacturer Baxter comes to an end.
The critical role transgenic animals could play in the future of
biopharmaceutical production has been tackled by a task force in a
new report out this week.
Thermo Fisher Scientific and Sartorius have signed a supply
agreement continuing the relationship between Sartorius and
Thermo's recently acquired TC Tech.
Technology and services provider Althea Technologies has stepped
closer to a significant increase in manufacturing capacity as it
announces the completion of the first phase of construction at its
new San Diego facility.
GE Healthcare has snapped up specialist in disposable manufacturing
technologies Wave Biotech, adding a host of new products and
services for the biopharmaceutical manufacturing sector to its
catalogue.
The European Union's (EU) member states must take their
responsibilities to implement the biotech policy proposed by the
European Commission (EC), said EuropaBio, the EU industry body.
A Brazilian firm has signed a licensing deal to take advantage of a
biopharmaceutical manufacturing technology which will allow the
company to locally manufacture complex biopharmaceuticals destined
for the South American market.
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.