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.
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.
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
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...
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.
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
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,...
As the US Food and Drug Administration continues its deliberations
on generic biopharmaceuticals, the industry body representing
generic drug manufacturers has said that the time has now come for
the agency to make some hard decisions,...
A second market research report has found evidence that production
capacity in the market for contract manufacturing of
biopharmaceuticals is now in excess, in contrast to the hitherto
prevailing wisdom that the sector has been suffering...
Construction of the UK National Biomanufacturing Centre, an
ambitious project aimed at helping biotechnology start-ups get
their product ideas into clinical trials, is progressing on
schedule and should be ready to start production...
US chemicals company Aceto has broken cover and is now racing to
develop a leading player in the market for generic versions of
biologic drugs, even though the regulatory route to approval of
these products is far from established.
The predicted deficit in manufacturing capacity for biologic drugs
that has been tipped to impede the development of the market has
not materialised, with capacity exceeding demand, according to new
Switzerland-based BioPartners has submitted a second Marketing
Authorisation Application in Europe for a generic copy of a
biologic drug under the recently agreed European Union framework
for so-called 'biosimilar' drugs.
Representatives of the pharmaceutical and biotechnology industries
presented strong opposition to the concept of biogenerics at a
recent meeting convened by the US Food and Drug Administration. As
expected, their argument centred...
The European Union is sponsoring a new initiative aimed at
producing pharmaceuticals in genetically modified crop plants such
as maize, and hopes to start the first clinical trials of a product
by 2009. But the news has been met with...
Earlier this week, the US Food and Drug Administration suspended
the approval of a generic version of Pfizer's high blood pressure
drug Norvasc (amlodipine besylate) developed by India's Dr Reddy's
US chemicals firm Aceto has bought the German Pharma Waldhof
business from Switzerland's Roche, making its first foray into the
market for biologically-derived active pharmaceutical ingredients
The new agreement between BioProgress and an unnamed US
over-the-counter pharmaceuticals firm could double the UK company's
capacity to manufacture cellulose films for drug encapsulation,
according to chief executive Graham Hind.
Funding shortfalls and a capacity gap are threatening to hamper the
European biopharmaceutical industry's progress and could lead to a
reduction in its global market share, according to new market
Merck KGaA drops plans to build a €300m biomanufacturing plant in
Jena, Germany, on the grounds that late-stage product failures have
left plenty of free capacity in the contract sector. The company's
move suggests that the often-repeated...