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...
Speciality chemical company Rohm and Haas has created a new
business unit, Advanced Biosciences, that specialises in the
production and purification of biopharmaceuticals. The new unit is
well placed to address the shortfall in production...
Spotlight on the home of the celebrated pork pie in England, with
the annoucement this week that Melton Mowbray-based Bridgehead
Technologies and Pharmalicensing - two biopharmaceutical business
development companies - are to merge.
US Neuro Bioscience has signed an agreement to acquire a minimum of
75 per cent of the issued and outstanding share capital of CLL
Pharma, a French company engaged in the business of reformulating
drugs using its proprietary drug...
Two British firms, De Novo Pharmaceuticals and Peakdale Molecular,
are to enter into a joint collaboration to exploit their respective
skills in molecular design and chemistry synthesis, writes market
analysts Datamonitor this week.
The bulk of biotech companies are firmly rooted towards the foot of
the ladder of corporate evolution. Precious few can realistically
claim to be at the top end of the evolutionary scale with full
R&D capabilities, global reach...
Nabi Biopharmaceuticals saw biopharmaceutical product sales -
driven by strong growth in sales of Nabi-HB - reaching record
levels of $89.5 million (€83m) in 2002, a 22 per cent increase from