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“Natural” Sutures
Tepha, Inc, received US Food and Drug Administration (FDA) approval to market the first absorbable polymer suture (Tephaflex) cultivated from genetically modified bacteria. With the help of recombinant deoxyribonucleic acid technology, certain chemicals that are difficult to manufacture in an industrial setting are more easily produced with living organisms. The polymer sutures are broken down and absorbed naturally over time, eliminating the time and costs associated with suture removal.
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Molecular Prognostic Breast Cancer Detection
Although available in Europe since 2005, Agendia received FDA clearance
to market their breast cancer prognosis test (MammaPrint) in the United
States. Analyzing a set of 70 genes from a sample of the excised tumor,
Agendia’s in vitro diagnostic multivariate index assay test measures
the probability of breast cancer recurrence in women 5 to 10 years after
the initial onset of cancer. With molecular microarray analysis, the measurements
are scored on a specific algorithm to predict the likelihood that a patient’s
cancer will metastasize. Prior
to FDA clearance, Agendia submitted clinical data from five European
centers that demonstrated the test was helpful at predicting the risk
of disease recurrence in women with stage
I and stage II cancer under age
61 years.
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Self-treatment for
Crohn Disease
Originally approved in 2005 for the treatment of psoriatic arthritis,
and later for moderate-to-severe rheumatoid arthritis and ankylosing spondylitis,
Abbott Laboratories’ tumor necrosis factor (TNF)-blocker, adalimumab
(Humira), recently received FDA approval for the treatment of moderately
to severely active Crohn disease. Basis of approval came from the findings
of three pivotal clinical trials, in which adalimumab was administered to
more than 1,400 Crohn disease patients who were unresponsive to in-fliximab
and anti–TNF-α therapy. Adalimumab is the first FDA-approved, self-administered
biologic indicated for the treatment of Crohn disease.
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Controlling High
Blood Pressure
Novartis Pharmaceuticals Corporation recently received FDA approval
for their oral aliskiren (Tekturna) tablets indicated for the treatment
of hypertension. Available in two dosages, aliskiren 150 mg/d and 300 mg/d
is the first direct renin inhibitor drug to receive FDA approval. Aliskiren
targets the early stages of hypertension by inhibiting the production of
renin and the blood vessel narrowing activity of the renin angiotensin system.
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Battling Heart Disease
Pfizer, Inc, received FDA approval for the expanded use of its drug atorvastatin 80 mg (Lipitor) for five new indications. Already used for the treatment of high cholesterol, atorvastatin is now approved to reduce the risk of nonfatal heart attacks, fatal and nonfatal strokes, hospitalization due to heart failure, and certain forms of heart surgery. Expanded approval was based on data from a 5-year clinical trial that tested the drug’s safety and efficacy in patients with heart disease and high levels of low- density lipoprotein. Results showed a 50% reduction in the occurrence of strokes with atorvastatin versus placebo.
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New Breast Cancer Drug
The FDA recently approved
GlaxoSmithKline’s lapatinib (Tykerb) in combination with capecitabine (Xeloda) for the treatment of metastatic human epidermal growth factor receptor-2 (HER2)-positive, node-positive breast cancer in patients unresponsive to prior treatments and therapies such as anthracycline, taxane, and trastuzumab. Unlike other breast cancer drugs, this kinase inhibitor binds to the overactive part of the HER2 protein found inside the cancer cell. Findings from a pivotal phase 3, double arm trial of 399 HER2-postive breast cancer patients showed that patients treated with capecitabine and lapatinib had a median time to disease progression of 27.1 weeks versus 18.6 weeks when treated with capecitabine alone.
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Improving Meningitis Detection
The FDA approved Cepheid’s application to market a new, fast-acting diagnostic test (Xpert EV) for the detection of viral meningitis. By delivering results in just 2.5 hours, Cepheid’s test minimizes delay in patient treatment. The fully-automated test detects the presence of meningitis by analyzing a sample of a patient’s cerebrospinal fluid. When used in combination with other laboratory tests, the test can help distinguish viral meningitis from the less prevalent, but more severe form of meningitis caused by bacteria. US Food and Drug Administration marketing approval followed the results of a multisite study of 255 patients at six different institutions, in which 96% of patients who tested positive for viral meningitis actually did have the disease.
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Improving Treatment
Elbit Medical Imaging Ltd received FDA approval for a new software to be used in
conjunction with their magnetic resonance imaging-directed uterine fibroid treatment system (Exablate 2000). The new software significantly reduces the treatment time for patients by utilizing ultrasound heat waves to burn away different parts of the uterine fibroid by alternating its focus from one part of the tumor to another. The interleaved mode of treatment speeds-up the dissolution of fibroid tumors by allowing recently ablated tissues time to cool before being naturally extruded from the body.
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Simplifying Diabetes Treatment
In response to patient concerns about the problems associated with the self-treatment of
diabetes, Eli Lilly and Company announced the introduction of the first “memory” savvy insulin pen (Humapen Memoir). Recording both the amount and time of dosage for a patient’s last 16 insulin shots, the pen’s innovative “push-to-know” feature helps simplify the daily management of diabetes. Designed to look like an actual pen, the device is now available for use with injectable insulin lispro.
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