Faced with a tougher operating environment, Irish drugmaker Elan has decided to slash staff numbers by 230 – or around 14 per cent of its total workforce – shelve the construction of a new biologics manufacturing facility and shutter fill-and-finish capacity...
Crucell and DSM Biologics have added fellow Dutch firm Bioceros to the PER.C6 vendor network to provide manufacturing and support capacity in line with increased demand for the cell line.
Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.
Late last week the US Department of Health and Human Services (HHS) awarded Novartis a $490m contract to continue work on its cell-culture influenza vaccine plant in Holly Springs, North Carolina, US. in-PharmaTechnologist spoke with Novartis spokesman...
Positive noises from an FDA panel on GTC Biotherapeutics’ recombinant antithrombin ATryn may further the use of transgenic animals for drug production but should the manufacturing process rather than the drug’s safety be our prime concern?
The completion of trial batches of Siga Technologies’ smallpox treatment ST-246 could not have been better timed following as it does the recomendation that the Obama government raise the threat of bio-terror up its list of concerns.
Biotech bodies from around the globe have been calling on their respective governments to provide stimulus packages to compensate for the current difficulties in obtaining credit.
Irish drugmaker Elan, which recently dropped plans to sell its Elan Drug Technologies operation, has announced job cuts and the closure of offices in a bid to save cash.
The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.
The possible sell-off of Enzon Pharmaceuticals’ biotechnology drugs business has come under fire by one of the firm’s shareholders, DellaCamera Capital Management, which says it is opposed to the move.
Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.
Abraxis has licensed rights to use ProMetic’s protein technology in the development of four new biopharmaceuticals that it hopes will generate around $600m (€422.5m) in US sales.
An increase in the sale of vaccines such as Quinvaxem and Epaxal, helped Dutch drugmaker Crucell reduce its loss some 56 per cent to €7.9m ($12.5m) in the second quarter.
Lonza is to co-develop and manufacture Novartis' biological pipeline as part of a long term strategic partnership that has been struck between the companies.
Invitrogen plans to cement its place as one of the world's largest
suppliers of analysis tools and reagents for the life science and
pharmaceutical industries by acquiring Applied Biosystems (ABI).
J&J has expressed its concern over patient safety as Novartis'
subsidiary Sandoz has received the green light from the European
Commission to launch the first epoetin alfa biosimilar on the EU
market.
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...
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...
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.
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.
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 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.
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...
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.
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.
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.
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...
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...
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,...
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...
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...
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...
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...
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.
The production capacity for biopharmaceutical manufacturing will
expand an average of 48 per cent over the next five years for
mammalian and microbial production systems, according to an
industry survey.
Pharmaceutical companies are increasingly looking to retain their
internal focus on research and development (R&D) and marketing
while outsourcing their manufacturing processes, thus fueling a
growing demand for the manufacturing...
Regulatory obstacles to the development of the market for
biogeneric drugs are falling down, and the first products are set
to reach the markets of North America and Europe in 2006-7,
according to consulting firm Frost & Sullivan.
Cambrex has recorded a gain in the second quarter of this year,
with growth in its Bioproducts and Human Health segments. The
performances overshadow the company's troublesome BioPharma
division, indicative of a market for outsourced...
Swiss chemicals firm and contract manufacturer Lonza fulfilled its
promise of stronger financial results in the first half of 2005,
with profits coming in at the lower end of the forecast range, but
still on target, reports Phil Taylor.
A recent study designed to assess biopharmaceutical innovation in
the member states of the Organisation for Economic Cooperation and
Development has found that, in terms of innovation and
biotechnology industry development, Belgium...
According to a recent report, the global bioinformatics market is
currently estimated at about $1.4 billion (€1.1 billion). It is
expected to grow at an average annual growth rate of 15.8 per cent
to reach nearly $3 billion by 2010,...
BioProgress has appointed Richard Trevillion as chief
executive, bolstering its executive management just over a month
after the dosage film specialist issued a trading statement that
sparked a 40 per cent slump in its UK-listed shares,...
