Saturday 30 August 2008

Instrumentation Laboratory Receives FDA Clearance To Expand The Intended Use Of HemosIL(R) D-Dimer Assay

�Instrumentation Laboratory
(IL) announced that the US Food and Drug Administration (FDA) has
granted 510(k) clearance to expand the intended use of goods and services for the HemosIL D-Dimer
assay to exclude venous thromboembolism (VTE) in outpatients suspected of
deep venous thrombosis (DVT) and pulmonary embolism (PE), when put-upon in
junction with a clinical pretest probability (PTP) assessment model.
HemosIL D-Dimer was originally released in 1998, for the quantitative
determination of D-Dimer in human citrated plasma and in 2005 was FDA
cleared for use as an aid in the diagnosis of VTE.


As a part of the 510(k), IL performed a multi-center clinical report
involving more than six-hundred patients in four different hospitals,
according to a strict protocol reviewed through the FDA. Using a cut-off
value of 230 ng/mL, the Negative Predicative Value was 100% for DVT and PE
on the ACL TOP(R) Hemostasis Testing System and 100% for DVT and 99.1% for
PE on the ACL ELITE(R) organisation.



In 2007, the FDA granted clearance for the same VTE exclusionary claims
with IL's second-generation HemosIL D-Dimer HS assay. Both assays at once have
proved clinical operation for the exclusion of DVT and PE when used with
a PTP assessment model and portion the same cut-off value.



"This expanded intended use for our D-Dimer check allows IL to provide
the tools healthcare professionals need to more accurately and efficiently
rule-out patients suspected of DVT and PE, regardless of the size of their
founding or the throughput of their analyzers," said Giovanni Russi,
Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are
passionate about development innovative products and offering all of our
customers a full range of solutions through our comprehensive portfolio of
hemostasis reagents and instruments."



HemosIL D-Dimer is fully automated on ACL systems, with time to results
in less than seven-spot minutes. It was the first D-Dimer test machine-controlled on IL's
ACL systems and since its launch, a great deal has been published approximately its
excellent performance for the diagnosing of both DVT and PE.

About VTE



DVT occurs when a blood coagulate forms in a large vein, normally in a leg. A
potentially fateful PE happens if the blood clog breaks idle, migrates to
the lungs and blocks a pulmonic artery or one of its branches. These
weather can go on after whatever surgery, as well as in patients with spinal
fractures and spinal-cord injury, though it is most commonly seen in
patients who experience recently undergone orthopedic operating room. Two hundred
thousand new cases of DVT and PE occur in the US each year and 20% suffer
sudden death as a final result of PE. Learn more by visiting http://www.preventdvt.org



Instrumentation Laboratory ( http://www.ilus.com ), founded in 1959, is a
cosmopolitan developer, manufacturing business and distributor of in vitro diagnostic
instruments, related to reagents and controls for use primarily in hospitals
and independent clinical laboratories. The company's product lines include
critical care systems, hemostasis systems and information management
systems. IL's GEM(R) product offerings, part of the critical care line,
include the new GEM Premier 4000 analyzer with Intelligent Quality
Management (iQM(R)), GEM Premier(TM) 3000 analyser, GEM OPL(TM), a portable
whole blood CO-Oximeter and the GEM PCL Plus, a portable coagulation
analyser. IL's hemostasia portfolio includes the ACL TOP(R) Family of
Hemostasis Testing Systems, fully machine-controlled, high-productivity analyzers,
including the ACL TOP and the new ACL TOP D CTS. IL also offers the ACL
ELITE(R) and ELITE PRO, other hemostasis analyzers and the HemosIL(R) line
of reagents. IL is based in Lexington, Massachusetts.


Instrumentation Laboratory (IL)
http://www.ilus.com



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Wednesday 20 August 2008

Abbott's Kaletra(R) Tablet Dosed Once-Daily Or Twice-Daily Demonstrated Similar Clinical Results Across Race And Gender Lines

�Initial treatment
regimens containing once-daily or twice-daily dosing of Abbott's (NYSE:
ABT) protease inhibitor Kaletra(R) (lopinavir/ritonavir) tablet provided
similar results for controlling the virus (reducing the amount of HIV-1)
and improving the immune system (increasing CD4 cells) in women compared to
manpower and in non-whites compared to whites, according to 48-week data
presented by Abbott at the XVII International AIDS Conference (AIDS
2008).



A retrospective sub-analysis of subject area M05-730 at week 48 of 96 weeks
offered data on the shock of gender and airstream on a Kaletra-based regime.
Women and non-whites have traditionally been underrepresented in HIV
studies, although these patient groups increasingly business relationship for the vast
majority of HIV infections. According to the World Health Organization, by
the end of 2007, 22.5 million of the total 33.2 million people infected
with HIV lived in sub-Saharan Africa. Additionally, 15.4 million of the
tally number of HIV-infected patients worldwide are women.



"The results showed that regardless of sex or raceway, Kaletra dosed
once-daily or twice-daily as part of a treatment regimen achieved
consistent virologic suppression in patients new to antiretroviral
therapy," said Scott Brun, M.D., divisional vice president, Infectious
Diseases and Immunology Development, Global Pharmaceutical Research and
Development, Abbott. "Additionally, the Kaletra tablet conceptualisation is a
convenient HIV treatment alternative that bathroom be taken with or without food for thought and
does not require refrigeration, which is in particular important to patients
in the developing world wHO are disproportionately affected by HIV."

M05-730 Analysis Results



Through 48 weeks, the proportions of males and females who achieved an
insensible HIV viral load were similar. In addition, the proportions of
whites and non-whites world Health Organization achieved an undetectable HIV viral encumbrance were
similar. Specifically, 72 percent of women and 78 percent of workforce, and 75
percent of non-whites and 77 pct of whites had insensible HIV viral
loads (less than 50 copies/mL) at 48 weeks.



CD4+ cell count mean increases over 48 weeks were interchangeable for females
and males, independent of baseline CD4+ cell count, except among women with
baseline CD4+ cell counts of fewer than 50 cells/mm3, world Health Organization experienced
statistically significant greater mean increases in CD4+ cell counts than
males. In summation, CD4+ cellular phone count mean increases over 48 weeks were
alike for whites and non-whites. At 48 weeks, the overall rate of
soften to stern and related adverse events of diarrhea was 15.8 per centum.
A similar rate of diarrhea was observed in whites (17.8 percentage), while
non-whites experienced a rate of 9.7 percent.



"This sub-analysis of M05-730 provides additional clinical information
on race and gender response with Kaletra," said Joseph Gathe, Jr., M.D.,
clinical instructor, Department of Internal Medicine, Baylor College of
Medicine. "The information tin can help physicians in making treatment
decisions for the patient populations most affected by HIV."

About the M05-730 Study -- 48-week Data

Design and Primary Endpoints:



-- M05-730 work is a 96-week Phase III open-label, randomized,
multi-center, multi-country study that enrolled 664 ARV-naive patients with
HIV-1 RNA >1000 copies/mL and any CD4+ T-cell count. Patients were
randomised equally to lopinavir/ritonavir 800/200 mg once-daily soft gel
capsule (SGC), 400/100 mg twice-daily (BID) SGC, 800 mg/200 mg once-daily
tablet or 400/100 mg twice-daily tablet for eight weeks. All patients also
received emtricitabine (FTC) 200 mg once-daily and tenofovir disoproxil
fumarate 300 mg once-daily. At calendar week eight, all patients receiving SGC were
switched to the tablet formulation of Kaletra, coordinated their old
dosing schedule of in one case or twice-daily.



-- The primary efficaciousness endpoint was the dimension of patients with
HIV-1 RNA


-- The primary safety endpoint was the proportion of patients reporting
a treatment-emergent adverse event of diarrhea during the number one eight weeks
of dosing. Additional prophylactic analyses included the proportion of subjects
reporting treatment-emergent adverse events, grade 3+ lab abnormalities,
and average changes from baseline for lab determinations through 48 weeks.

Primary Efficacy Results:



-- At week 48, the primary efficacy analysis showed that 77 percent of
the once-daily-treated patients and 76 per centum of the twice-daily treated
patients achieved a viral load


-- Through week 48, 14.7 percent and 16.6 percent of the patients
discontinued treatment on the once-daily and twice-daily regimens,
respectively. A similar portion of patients on the once-daily regime
discontinued imputable to inauspicious events, as on the twice-daily regime (4.8
percent and 3 per centum, respectively).



-- With regard to the comparison of the SGC to the tablet formulation
through week eight, there were no statistically meaning differences in
the undermentioned areas: the number of patients discontinuing due to
gastrointestinal contrary events or other adverse events; the incidence of
treatment-emergent untoward events of diarrhea of any badness and of
moderate or greater severity and related to the study dose; the proportion
of patients with Grade 3+ science laboratory abnormalities; or the bastardly change from
baseline for total cholesterin or triglycerides at whatever time point during
the first eight-spot weeks of treatment.



-- The to the highest degree common moderate/severe related untoward events in the
once-daily and twice-daily groups respectively were: looseness (17 percent
versus 15 percent), nausea (seven percent versus five percent), disgorgement
(three pct versus four percent), and increased triglycerides (two
pct in both groups). There was no statistical difference between the
groups.



-- At calendar week 48, the overall impact of Kaletra, dosed once-daily or
twice-daily, on grade 3-4 science laboratory abnormalities, including cholesterol and
triglycerides, the liver enzymes, SGOT/AST, and creatinine clearance was
similar.



-- At week 48, there was a statistically significant difference in the
increase of total cholesterin between the once-daily and twice-daily group.

About Abbott's Commitment to Fighting HIV/AIDS



HIV/AIDS is a global trouble that demands shared dedication and shared
responsibility. Abbott is committed to working with governments,
multilateral organizations, nongovernmental organizations and patient
groups to expand access code to HIV treatments close to the man. Abbott has also
made significant investments in expanding manufacturing capacity to gather
the growing demand for HIV treatment in development countries.



Abbott's lopinavir/ritonavir formulations are among the lowest-priced
protease inhibitors in the developing world. Abbott has been providing its
HIV medicines at a price of US$500 per grownup patient per year in all
African and least developed countries since 2002, making these medicines
more affordable than any generic copies.



Abbott and the company's benevolent foundation, Abbott Fund, have
invested more than US$100 million in the engagement against HIV/AIDS in Africa
and the developing domain. Abbott Fund-supported programs have served more
than 700,000 children and families. In addition, more than 250,000 patients
let been tested through Abbott Fund-supported voluntary counseling and
testing programs, with thousands being referred to intervention programs.
Abbott also has donated more than ashcan School million rapid HIV tests to help
prevent mother-to-child HIV transmission.



Abbott and Abbott Fund have proclaimed several efforts to amplify access
to treatment and care for children living with HIV/AIDS, including an
additional investment of US$12 million in grants and product donations this
year.



For more than information almost Abbott's commitment to fight HIV/AIDS,
please visit http://www.abbott.com/hiv.

About Kaletra

Indication



KALETRA (lopinavir/ritonavir) is a human immunodeficiency virus-1
(HIV-1) protease inhibitor. KALETRA is constantly used in combination with
other anti-HIV-1 medicines for the treatment of HIV-1 infection. KALETRA is
a combination of two medicines, lopinavir and ritonavir. KALETRA is for
adults and for children age six-spot months and older.

Important Safety Information



KALETRA does not cure HIV-1 infection or AIDS and does not reduce the
risk of passing HIV-1 to others.



KALETRA must not be taken by patients world Health Organization have had an sensitised reaction
to KALETRA or any of its ingredients.



Taking KALETRA with certain drugs canful cause serious problems or death.
KALETRA must non be taken with dihydroergotamine, ergonovine, ergotamine or
methylergonovines such as Cafergot(R), Migranal(R), D.H.E. 45(R), ergotrate
maleate, and methergine, as well as Halcion(R) (triazolam), Orap(R)
(pimozide), Propulsid(R) (cisapride), or Versed(R) (versed).



KALETRA must not be taken with rifampin, too known as Rimactane(R),
Rifadin(R), Rifater(R), or Rifamate(R); St. John's Wort (hypericum
perforatum); Mevacor(R) (lovastatin), or Zocor(R) (simvastatin).



There are drug-drug interactions with the potential for risk of serious
or grievous side personal effects. Alterations in dose, increased monitoring
of drug levels in the blood, or increased observations for side effects may
be recommended when KALETRA is interpreted with: Lipitor(R) (atorvastatin),
Crestor(R) (rosuvastatin), Viagra(R) (sildenafil), Cialis(R) (tadalafil),
Levitra(R) (vardenafil), oral contraceptives ("the pill") or the
prophylactic device patch, Mycobutin(R) (rifabutin), inhaled Flonase(R)
(fluticasone), metronidazole, or disulfiram. Patients should lecture with
their doctor about all medicines they are taking or planning to take,
including those without a prescription and herb tea products.



KALETRA should not be disposed once-daily in combination with Sustiva(R)
(efavirenz), Viramune(R) (nevirapine), Agenerase(R) (amprenavir),
fosamprenavir, Viracept(R) (nelfinavir), purple heart, Dilantin(R)
(phenytoin) or Tegretol(R) carbamazepine.



Patients and/or their care providers should pay special attending to
accurate administration of the KALETRA dose to reduce the risk of
accidentally giving too much or to a fault little medical specialty.



The to the highest degree commonly reported side effects of temper severity that are
view to be drug related to are ab pain, abnormal bowel movements,
diarrhea, feeling weak/tired, head ache and sickness. Children taking KALETRA
may sometimes start out a peel rash. Other side effects may occur.



Pancreatitis and liver problems, which can be disastrous, have been reported
in patients receiving KALETRA. Patients should tell their doctor if they
have nausea, vomiting, or abdominal pain in the ass, which may be signs of
pancreatitis, or if they have or induce had liver disease, such as hepatitis
B or C.



Some patients deliver had big increases in triglycerides and
cholesterol. Changes in body fat have been seen in some patients taking
anti-HIV therapy. The semipermanent health personal effects of these conditions are not
known at this time.



Diabetes and high blood sugar have occurred in patients taking protease
inhibitors, such as KALETRA.



Some patients with haemophilia have increased bleeding with protease
inhibitors.



The effects of KALETRA on pregnant women or their unborn babies are not
known. Mothers taking KALETRA should not suck.



All strengths of KALETRA tablets should be swallowed whole and not
chewed, broken, or crushed.



KALETRA tablets should be stored at room temperature. Exposure of this
product to high humidness outside the pharmacy container for yearner than two
weeks is not recommended.



Refrigerated KALETRA oral solution remains stable until the expiration
escort printed on the label. If stored at room temperature up to 77 degrees F
(25 degrees C), KALETRA oral solution should be used within two months.



Avoid exposure to inordinate heat.

Abbott and HIV/AIDS



Abbott has been a leader in HIV/AIDS research since the early years of
the epidemic. In 1985, the ship's company developed the first licenced test to
detect HIV antibodies in the stock and remains a leader in HIV diagnostics.
Abbott retroviral and hepatitis tests are victimised to concealment more than half of
the world's donated blood supply. Abbott has developed two peptidase
inhibitors for the handling of HIV.

About Abbott Fund



Abbott Fund is a philanthropic base established by Abbott in
1951. Abbott Fund's deputation is to create fitter global communities by
investment in originative ideas that promote science, expand wellness care and
strengthen communities worldwide.

About Abbott



Abbott is a worldwide, broad-based wellness care troupe devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs more than 68,000 hoi polloi and markets its products in more
than one hundred thirty countries.



Abbott's news releases and other information ar available on the
company's Web land site at hypertext transfer protocol://www.abbott.com. For more information on
Abbott's HIV/AIDS programs, please bring down http://www.abbott.com/hiv and
hypertext transfer protocol://www.abbottglobalcare.org.


Abbott
http://www.abbott.com


View drug information on Agenerase; Cialis; Crestor.



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Sunday 10 August 2008

Madonna and hubby accused of price fixing

Madonna and Guy Ritchie have been accused of price fastening at their London pub.



The couple bought 18th 100 pub The Punchbowl in London's Mayfair six months ago, simply it is claimed staff at the venue go a two-tier pricing system, with tourists being charged more for drinks than locals.


Pub visitor Brian Richardson said: "On Monday I paid �3.50 for a pint, now all of a sudden it's �3.90. I was shocked. I complained to staff.


"They hold got deuce prices - regulars' prices and non-regulars' prices. "I don't mind paying more than but it is completely arbitrary. It is non the money, it is the terms hike. It is outrageous."


His friend Andy Kneller added: "When Brian realised how much he was stipendiary he disputed it. We know the governor. "He did say we have prices for regulars and prices for people wHO don't descend here very often.


He dropped himself in it." There is besides no price list on display at the pothouse, which is a effectual requirement.


Westminster Council is investigation the claims, which could even trail to the venue losing its license.


Assistant manager Henry Heaton vehemently denied the allegations, expression: "It is not true at all that we fail to have tariffs on display and bear down different prices.


"The price heel is up on the bar now. What has happened is some of the prices have changed.


"And it is not slump to suppose that regulars get drinks at better prices than tourists."


A spokesman for Madonna and Guy said the couple would not be commenting on the allegations.






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