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News
GPhA
Seeks Additional ODG Funding, Not User Fees
The
Generic
Pharmaceutical Association
(GPhA, Washington DC) says that more funding for US
Food and Drug Administrations' Office of Generic Drugs
(OGD,
Rockville, MD) would produce more benefits than the agency's proposal
for generic-maker user fees. (More)
Drug
Sales Up 5.4%...But Growth Rate Slowing
As
IMS
Health
(Fairfield, CT) is reporting that prescription drug sales grew by 5.4%,
a task force of the federal Centers
for Medicare and Medicaid Services
(CMS) reports that the spending-growth-rate is falling, thanks to
increasing reliance on generics. (More)
Cambrex
Reports Loss; Advances Biosciences Business
Reflecting
the vagaries of the custom-manufacturing market, Cambrex
Corporation
(East Rutherford, NJ), a custom manufacturer and provider of life
science services and products, reported a full-year 2005 net loss of
$129.2 million on sales of $452 million. The results include an
$87.2-million goodwill impairment charge and a $35.8-million charge to
reduce the carrying value of long-lived assets. The impairment charge
mainly stems from weakness in the company’s contract biopharmaceutical
process development and manufacturing business. (More)
Warning
Letter: Southern Meds
On
Feb. 15, the US
Food and Drug Administration's
New Orleans’s District Office (New Orleans, LA) posted a Warning
Letter to Southern
Meds(Biloxi,
MS), a compounding pharmacy. (More)
Lonza
Plans Biomanufacturing Facility in Singapore
Lonza
Group
(Basel, Switzerland), a custom manufacturer and fine chemicals supplier,
and Singapore’s Bio*One
Capital Pte. Ltd. (Singapore),
the investment arm of the Singapore Economic Development Board, are
investing $250 million to jointly build a large-scale mammalian cell
culture plant in Singapore for the manufacture of commercial
biopharmaceuticals. The facility will be Lonza’s second large-scale
mammalian manufacturing plant. (More)
Vaccines
FDA
Recommends Changes for 2006–2007 Flu Vaccine
The
emergence of two new influenza strains has led the US
Food and Drug Administration
(Rockville, MD) to recommend changes for next season’s flu vaccine.
(More)
Baxter
Wins Contract to Develop Cell-Based H5N1 Vaccine
The
European subsidiary of Baxter
International
(Deerfield, IL) has won aUK
National Health Service
contract to develop two million doses of a cell-based candidate H5N1
influenza vaccine and complete delivery of the stockpile this year.
(More)
First
Phase I Study Proves Safety, Immune Response of Ebola DNA
Vaccine
A
Phase I trial conducted on an Ebola vaccine candidate developed by
theNational
Institute of Allergy and Infectious Diseases
(NIAID, Bethesda, MD) and administered using proprietary DNA delivery
technology from Vical
Inc.(San
Diego, CA) has shown the vaccine to be safe, well tolerated, and capable
of producing both antibody and T-cell Ebola-specific responses in
humans. (More)
Featured
Story
Developments
in Powder Flow Testing
The
pharmaceutical industry's focus on process understanding, monitoring,
and control is driving manufacturers to take greater steps toward
identifying possible manufacturing bottlenecks earlier in the
development process. For tablet, capsule, and excipient producers, such
efforts include taking a closer look at the flow-ability of their
powders.
There
are only two truths when it comes to powder flow analysis: Powders are a
complex material and no one single test method is the best. Everything
else is debatable.
The
US Pharmacopeia first started working toward standardizing the methods
to measure powder flow with a survey and a "Stimuli to the Revision
Process" article in Pharmacopeial Forum published in 1999. Since then, a
harmonized general information chapter on powder flow has been released
for the more traditional methods and sophisticated analyzers have been
introduced and are slowly finding their way into pharmaceutical
laboratories. (More)
In
the Spotlight
 Ceramic–metal
flowmeter
“Batchcontrol”
is an electromagnetic flowmeter recently introduced by Krohne
(Peabody, MA, www.krohne.com).
Batchcontrol’s flow tube is made entirely of a special ceramic that
can withstand rapid temperature changes, thus enabling the device to
be cleaned or steamed in place. The flowmeter also features cermet
(fused ceramic and metal) electrodes, which eliminate gaps in the flow
tube.
Joe Incontri,
director of sales and marketing for Krohne, says that Batchcontrol
also features embedded control of valves. The unit can manipulate as
many as six valves without additional commands from the programmable
logic control. In addition, Batchcontrol operates on a CANbus network,
so it communicates with equipment faster and with fewer cables than
other flowmeters. Incontri explains that the network “saves [users] a
lot of money and could help them optimize their machine designs in
ways they could never do before.”
Correction:
The spotlight entry
in last week's ePT ran incorrectly.
The entry should have read as above.
Company
News
PLIVA (Zagreb, Croatia,
www.pliva.com) signed an agreement
with Novartis’s generics division, Sandoz (Holzkirchen,
Germany, www.sandoz.com), for the purchase of
its Spanish subsidiary Uso Racional S.L. for EUR 21.5 million. The
company has also reached a separate agreement with GlaxoSmithKline(Middlesex, UK,
www.gsk.com) for the purchase of
PLIVA’s proprietary research and development in Zagreb,
Croatia.
Excelsyn
Group (Newcastle, UK,
www.excelsyn.com), a provider of
contract manufacturing, consulting, and pharmaceutical engineering
services, has acquired a minority stake in Angel
Biotechnology Holdings PLC(Cramlington, UK,
www.angelbio.com), a provider
of process development
services and pre-GMP and CGMP manufacturing to the biotechnology and
pharmaceutical industries. Excelsyn has been working with Angel through
its engineering technology service cluster to build a fermentation
facility within Angel’s Cramlington, UK site. This has led to the
introduction of biotechnology and biotransformations into Excelsyn’s
molecular development cluster and includes the production of unnatural,
chiral amino acids. Angel operates two facilities. The Cramlington
facility has 750-L fermentation capacity, process development
laboratories, and a pilot plant. The GMP-licensed facility in Pentlands
Science Park, Scotland has small-scale protein manufacture and stem
cell–cellular therapy capabilities.
Evotec
AG (Oxford, UK,
www.evotec.com), a provider of
contract research, manufacturing, and drug discovery services, and
Apeiron
Biologics GmbH(Vienna, Austria,
www.apeiron-biologics.com), a biotechnology
company, have formed a discovery collaboration to develop small-
molecule assays for pain-relief therapeutics based on research of Josef
Penninger, director of the Institute
for Molecular Biotechnology of the Austrian Academy of
Science.
Degussa
Homogeneous Catalysts (DHC), an internal
start-up of Degussa
AG (Düsseldorf, Germany,
www.degussa.com) has launched
“catMETium IMesPCy,” a catalyst for olefin metathesis for pharma
applications. The catalyst is an alkylidene ruthenium complex with aa
N-heterocyclic carbene
ligand. The catalyst can be used in cross-metathesis, ring-closing, and
ring-opening metathesis. To market this technology, DHC has taken
licenses under patents generated by Wolfgang A. Herrmann et
al. (Technische
Universität München, Germany) and field-of-use licenses under patents
generated by Steven P. Nolanet
al. (University of New
Orleans, LA).
PCAS (Longjumeau, France,
www.pcas.fr/eng/index.asp), a custom
manufacturer and fine chemical supplier, and Protéus (Nîmes,
France,www.proteus.fr), a manufacturer of
proteins and bioprocesses, have formed PCAS Biosolution, a joint venture
focused on the synthesis of active pharmaceutical ingredients,
intermediates, and building blocks, using chemo-biocatalytic
manufacturing routes. PCAS Biosolution will have exclusive license
rights to the intellectual property platform from both PCAS and Protéus
for chemical process development and pharmaceutical manufacturing. Last
year, Protéus launched Protéus Services for Industry, a new business
unit that provides protein engineering and production services for the
life sciences industries.
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India – the talk of the pharma industry
(updated)
