Pfizer Inc. Receives FDA Approval For Exubera - The
First Inhalable Form Of Insulin For Controlling Type 1 And Type 2
Diabetes In Adults
Pfizer Inc announced that Exubera® (insulin human [rDNA origin])
Inhalation Powder has been approved by the U.S. Food and Drug
Administration for the treatment of adults with type 1 and type 2
diabetes. Exubera was found in clinical trials to be as effective as
short-acting insulin injections, and to significantly improve blood
sugar control when added to diabetes pills. Exubera, which is
expected to be available for patients by mid-year, is the first
inhaled form of insulin and the first insulin option that does not
need to be administered by injection in the United States.
Exubera is a rapid-acting, dry powder human insulin that is
inhaled through the mouth into the lungs prior to eating, using the
handheld Exubera Inhaler. The Exubera inhaler weighs four ounces
and, when closed, is about the size of an eyeglass case. The unique
Exubera Inhaler produces in its chamber a cloud of insulin powder,
which is designed to pass rapidly into the bloodstream to regulate
the body's blood sugar levels.
FDA Warns Boston Scientific
The U.S. Food and Drug Administration has sent a letter to Boston
Scientific warning of ongoing quality control issues, the medical
device maker said Friday.
The letter warned Boston about the procedures, processes, and
timeliness of the company’s quality management system. It also
warned Boston about “ongoing systemic violations” of the FDA’s
quality control standards.
The warning letter advised Boston Scientific that recent FDA
inspections at three of its facilities had uncovered serious
regulatory problems. The FDA told top management that the
corporate-wide corrective actions it had undertaken in response to
three prior warning letters last year were inadequate.
The FDA’s letter also expressed concern about Boston’s quality
control systems at six of its facilities, along with recent recalls.
January 31st:
Roche's Tamiflu gets EU nod for children
Swiss drugmaker Roche Holding AG has received approval in the
European Union for its Tamiflu treatment to be used to prevent
influenza in children aged from one to 12 years, the firm said on
Tuesday.
Tamiflu, which is also being stockpiled by governments to ward
off a bird flu pandemic, is approved in Europe, Japan and the United
States as a prescription treatment for seasonal flu.
The EU approval, which follows a similar regulatory nod from U.S.
authorities in December, allows the drug to be used prophylactically
in children, helping to prevent the spread of the disease, Roche
said.
Misonix Receives FDA 510(k) Clearance for Laparoscopic HIFU
Product
Misonix, Inc, a developer of ultrasonic medical device technology
for the treatment of cancer and other health conditions, announced
that FDA has granted 510(k) clearance for Misonix to market and sell
the Sonatherm 600 Ultrasonic Lesion Generating System in the U.S.
for ablation of certain soft tissue lesions in General Surgery
procedures.
The Sonatherm 600 Ultrasonic Lesion Generating System is based on
the Company's High Intensity Focused Ultrasound ("HIFU") technology
licensed from Focus Surgery. Treatment entails placing the Sonatherm
600 transducer on the surface of the organ to be treated and
engaging the HIFU energy. The concentrated acoustic waves quickly
ablate the targeted tissue without puncturing or cutting the organ
itself. The treatment may be performed in either laparoscopic or
intraoperative procedures.
February 1st:
GlaxoSmithKline Announces Approval and Availability of
Avandaryl(TM)
GlaxoSmithKline announces the availability of Avandaryl(TM) (rosiglitazone
maleate and glimepiride), a new fixed-dose combination product for
type 2 diabetes. Recently approved by the U.S. Food and Drug
Administration (FDA), Avandaryl is the first and only tablet to
combine a thiazolidinedione (TZD), rosiglitazone maleate -
separately marketed as Avandia® - with a sulfonylurea, glimepiride -
separately marketed as Amaryl® - to help improve blood sugar
control. As an adjunct to diet and exercise, Avandaryl is indicated
to improve blood sugar control in patients with type 2 diabetes who
are already treated with a combination of rosiglitazone and
sulfonylurea or who are not adequately controlled on a sulfonylurea
alone or for those patients who have initially responded to
rosiglitazone alone and require additional blood sugar control.
February 2nd:
Medtronic Sues Biomet and EBI Spine for Patent Infringement
Medtronic, Inc. announced that its spinal business, Medtronic
Sofamor Danek, Inc., has filed suit against Biomet Inc. and its
subsidiary EBI Spine, L.P. for patent infringement. The suit, which
involves seven Medtronic patents and seeks injunctive relief and
monetary damages, was filed in the United States District Court for
the District of New Jersey.
Three of the patents (6,916,320; 6,592,586; 6,428,542) were
purchased by Medtronic in 2005 from Gary K. Michelson, M.D. and
involve single-lock anterior cervical plating systems used in
cervical spinal fusions. Medtronic claims that a cervical plate
marketed by Biomet under the trade name VueLock(R) Anterior Cervical
Plate System, and openly promoted as a plate that has a "Secure One
Step Locking" mechanism feature, infringes these Michelson patents,
now owned by Medtronic. In previous litigation, Biomet and its
subsidiary Cross Medical, were found to infringe two different
Medtronic cervical plate patents.
The other patents (5,810,878; 6,036,692; 6,440,133; 6,790,209)
involve rod reducer instruments and surgical implantation methods
commonly used in spinal surgeries to implant pedicle screws.
Biomet's pedicle screw systems utilize a rod reducer instrument in a
variety of lumbar and thoracic spinal fusion surgeries. Rod reducers
are integral to modern spinal surgery, reducing operating room time,
improving efficiency and enabling surgical corrections that would be
unattainable without the device.
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