Following numerous manufacturing failures, Discovery Laboratories
believes it has resolved the stability issues that have plagued
Surfaxin, its experimental respiratory treatment for infants, and
is now seeking a meeting with the...
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.
A majority stake in Irish biotechnology contract services firm
Archport has been snapped up by German-based Chemie Uetikon as the
bio-outsourcing market heats up.
The US Food and Drug Administration (FDA) has issued new advice to
aid manufacturers in developing safe and effective cell-based viral
vaccines, hoping it can modernise America's manufacturing network
and speed up production.
Drug manufacturers can better understand how they can achieve
regulatory compliance and avoid production stoppages and recalls by
following new guidance issued by the US Food and Drug
Administration (FDA).
Drug developing services provider Aptuit has acquired the
pharmaceutical services division of technology firm EaglePicher,
enriching its active pharmaceutical ingredient (API) and drug
substance manufacturing offerings.
Targeting the market for drug metabolite identification and
biomarker discovery, Tandem Labs has acquired PharmaKD, a
Massachussets-based division of Linden Technologies.
With the first clinical trial of its cell culture-based seasonal
influenza vaccine commencing in the US, Sanofi Pasteur has
demonstrated the production scale potential of a cell line in a
successful bioreactor run of 20,000L.
US contract pharmaceutical manufacturer Metrics has announced a
$17.5m (€13.7m) investment to double the size of its drug testing
and manufacturing plant over the next three years.
Chemir Analytical Services, the new owner of Gateway Chemical
Technology, has renamed the custom chemical analysis business
IQsynthesis in a revamp effort.
The UK subsidiary of Nicholas Piramal (NPIL) is working on a new
catalyst-based racemisation technology called SCRAM that delivers
significantly improved process yields in the production of chiral
amines and alcohols, cutting cost...
Ferro Pfanstiehl Laboratories has commissioned a new validated
current good manufacturing practice (cGMP) supercritical
fluid-based particle engineering pilot facility, offering sizing,
purification and formulation services to its...
Bilcare, India's largest research-based pharmaceuticals packaging
company, has bought UK-based clinical trials services (CTS)
provider DHP in a bid to build itself up to be one of the few
players in this sector with global servicing...
Moving from egg-based production of vaccines to the use of
cell-culture technologies in existing manufacturing plants is
cheaper and quicker than building new facilities to handle a flu
pandemic within the next five years, new research...
To escape stagnating growth, hospital supplies firm Hospira has
agreed to buy Australia's Mayne Pharma for $2bn (€1.56bn), creating
the world's biggest manufacturer of generic injectable drugs.
Bentley Pharmaceuticals has announced it will use the North
Carolina facilities of US-based services provider Cardinal Health
for the scale-up and manufacture of the clinical supplies of its
new intranasal insulin product.
Instrumentation supplier TTP LabTech has just launched a new
business aimed at providing integrated custom automation systems to
the pharmaceutical industry.
Canadian firm Bioxel has manufactured the first industrial-scale
current good manufacturing practice (cGMP) batch of its key
intermediate for docetaxel, the active pharmaceutical ingredient
(API) of Sanofi-Aventis's blockbuster...
Catalyst specialist Reaxa has launched the latest flight of
additions to its range of metal scavenging products for pharma
process applications which can be used in both batch and continuous
processing.
Cardinal Health has been given the green light from the US Food and
Drug Administration (FDA) to start manufacturing the first
commercial drug at its new sterile facility in North Carolina.
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...
Kemwell has sealed the deal on the purchase of Pfizer's Swedish
manufacturing plant and at the same time secured a long-term
contract manufacturing agreement with the drug giant.
Successful technology transfer and effective management can help
avoid disappointment with contract manufacturing arrangements,
which often fail to live up to pharmaceutical company expectations.
A small spin-out company formed by the University of Colorado has
been awarded a $850,000 (€670,000) grant from the US government to
develop a dry powder inhalable version of Nabi's investigational
injectable vaccine for nicotine...
India's Essel Propack, the largest speciality packaging company in
the world, is acquiring Packaging India Private Limited (PIPL) from
the CavinKare Group, keen to capture more of the country's booming
pharmaceutical packaging...
Wyeth has entered into a global agreement that allows it to use
Intracell's synthetic adjuvant IC31 in the formulation of five of
its investigational vaccines, aiming to simply mix it with antigens
without the need for conjugation.
Drug testing services provider Xceleron has set up new facilities
in the US after regulations recently introduced by the Food and
Drug Administration (FDA) are setting this industry sector ablaze.
A good selection process, with a realistic set of selection
criteria is essential when looking for the right contract
manufacturing partner, according to a new Datamonitor report.
Biotechnology firm Codexis says it has reached an important
development milestone in its effort to design a biocatalytic
process to produce a key intermediate for a Schering-Plough drug,
reducing manufacturing costs and environmental...
The majority of pharmaceutical manufacturers who have adopted the
lean manufacturing model are not satisfied with their results
according to a new survey, raising questions about the efficacy of
a system popular in the automotive...
Offshoring contract manufacturing is not the only option for large
pharma firms looking to drive productivity and efficiency gains in
drug manufacturing, warns a new report from independent market
analyst Datamonitor.
New research show that the outsourcing trend is set to drive the
analytical laboratory market over the next seven years, however
small labs are in danger of drowning in the process.
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.
Thermo Electron introduces its rapid mixing accessory that is
designed for use with Thermo's Evolution 300 UV-Vis
spectrophotometer offering scientists reliable and precise
measurement of fast reaction kinetics.
Portuguese drug producers are small and need to merge or form
alliances to compete at a global level, investing more in
innovation and increasing their competitiveness like custom
manufacturer Hovione has done, a new report by market...
After selling a manufacturing plant in Texas to Cardinal Health two
years ago, Adams Respiratory Therapeutics has reacquired the
facility in order to produce its expectorant Mucinex (guaifenesin
extended-release), responding to a...
In an attempt to counter competition in generic active
pharmaceutical ingredients (APIs) from Asian manufacturers, BASF
has decided to downscale production at its Minden production site,
implementing a restructuring programme that...
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).
Germany's Merck has announced its biggest investment in
pharmaceuticals in its 338-year-old history, as its top-selling
oncology drug Erbitux (cetuximab) has driven the company to
allocate €190m for the construction of its first...
In the first drug master file (DMF) approval of its kind, the US
Food and Drug Administration (FDA) has approved the sale of
metformin hydrochloride tablets which are produced by an Indian
company using a pharmaceutical formulation...
Canadian contract manufacturer Patheon has teamed up with specialty
pharmaceutical firm Depomed to offer its clients a controlled
release formulation which can grant their drugs increased
bioavailability and less frequent dosing.
Biopharmaceutical firm Altus has asked contract manufacturer Althea
to produce Phase III quantities of a crystallised formulation of
human growth hormone (hGH) which can be administered subcutaneously
weekly instead of daily.
Thermo Electron has reported an operating profit growth of 26 per
cent to $143.2m (€111.2m) and boosted its profit margin by three
percentage points to 20 per cent in its second quarter results.
Fisher Scientific has reported a second-quarter pre-tax profit jump
of 31 per cent to $146.1m (€113.4m), reflecting the success of
recent acquisitions and operating initiatives.
Difficulties in identifying tablets have emerged as a major issue
in a recent US survey of 150 pharmacists who are warning drugmakers
that the lack of distinct appearance in pills leads in dispensing
errors that cost more than 7,000...
Despite its consolidation, the competitive consumable sector still
offers potential for rapid growth and better profits in the
biopharmaceutical industry, while contract bioprocessing services
will be increasingly in demand, according...
For the first time Merck has opened the doors of its
under-construction manufacturing plant in North Carolina to public
officials, boasting it will eventually contribute about two-thirds
of its annual live-virus vaccine production.
A survey of eleven production plants of major drugmakers has
revealed considerable variation in capacity utilisation, with the
top performers being those who embrace automation and spend little
on non-core activities.
Instrumentation provider ABgene has launched the first automated
device for the opening and closing of screw caps on sample tubes
that it claims is three times faster than the manual method.
