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 BIO International Convention in Boston officially began
yesterday amid relative peace after concerns over possible large
and violent protests failed to materialise.
Biologic drugs are expected to account for over a quarter of
overall drug spending in the US by 2010, new research has revealed,
and clearing the path for generic versions of these drugs could be
a solution to controlling rising national...
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.
