FDA announces new program to transform and strengthen medical
device safety
The U.S. Food and Drug Administration (FDA) is launching a new
program to transform and strengthen the way it currently monitors
the safety of medical devices after they reach the market. The FDA
Center for Devices and Radiological Health's (CDRH) Postmarket
Transformation Initiative will better protect the public health by
allowing the FDA to identify, analyze and act on problems more
quickly, including alerting the public sooner of potential medical
device issues.
The FDA undertook this initiative after a comprehensive,
year-long internal inventory of the tools used to monitor the safety
of medical devices after they are approved. This inventory
identified many areas that are working well; however, it also
identified challenges associated with medical devices after they
reach the market.
Areas the initiative will focus include:
- Working toward an electronic reporting system for adverse
medical device events;
- Unique ways to identify medical devices including standardized
and globally accepted names;
- Ways to improve device information in patient records;
- Improved internal collaboration on post market safety issues;
and
- Identifying opportunities to improve the safety of medical
devices through collaborative efforts with professional
organizations and the medical device industry.
January 25th:
Boston Scientific Corporation and Guidant Corporation Announce
Signing Of Merger Agreement Valued At $27 Billion
Boston Scientific Corporation and Guidant Corporation announced
that the Board of Directors of Guidant has unanimously approved and
entered into the merger agreement provided to Guidant by Boston
Scientific on January 17, 2006. Under that agreement, Boston
Scientific will acquire all the outstanding shares of Guidant for a
combination of cash and stock worth $80 per Guidant share, or
approximately $27 billion in aggregate. Prior to entering into this
agreement with Boston Scientific, Guidant terminated its merger
agreement with Johnson & Johnson. As a highly diversified company
with leading positions in growth markets, Boston Scientific/Guidant
will be one of the world's preeminent medical device companies, with
total revenue in 2006 of nearly $9 billion.
The transaction is subject to customary closing conditions,
including clearances under the Hart-Scott-Rodino Antitrust
Improvements Act and the European Union merger control regulation,
as well as approval of Boston Scientific and Guidant shareholders.
The transaction is not subject to any financing condition. Boston
Scientific expects to complete the transaction by the end of the
first quarter of 2006.
In addition, Boston Scientific has entered into an agreement with
Abbott under which Boston Scientific has agreed to divest Guidant's
vascular intervention and endovascular businesses, while agreeing to
share rights to Guidant's drug-eluting stent program. Under its
agreement with Abbott, Boston Scientific will receive $6.4 billion
in cash from Abbott on or around the closing date of the Guidant
transaction. This amount consists of $4.1 billion in purchase price
for the Guidant assets, a loan of $900 million, and Abbott's
agreement to acquire $1.4 billion of Boston Scientific common stock.
Boston Scientific and Guidant believe that Boston Scientific's
agreement with Abbott will enable Boston Scientific and Guidant to
rapidly secure antitrust approvals for the proposed transaction.
J&J misses on sales, meets net target
Health-care giant Johnson & Johnson on Tuesday reported a rise in
net income, meeting analysts' expectations, but saw its revenue fall
more than 1% in the wake of weaker-than-expected sales from its core
pharmaceuticals division.
The Dow Jones Industrial Average component JNJ posted net income
of $2.2 billion, or 73 a cents a share, compared with the $1.2
billion, or 41 cents, earned in the year-earlier period.
Year-earlier results included a charge of $789 million, or 26 cents
a share, related to taxes on earnings repatriated under the American
Jobs Creation Act.
Revenue fell 1.1% to $12.61 billion from $12.75 billion. The
latest quarter included 13 weeks; the comparable year-earlier
quarter comprised 14. Domestic sales for the quarter fell 4.2%,
while international sales grew 3.1%, hurt by a negative currency
impact of 4.4%, J&J said. Quarterly worldwide pharmaceutical sales
were off 6.1% from last year, coming in at $5.48 billion.
Medical-device sales were cheerier for J&J, rising 3.7% to $4.82
billion. Management said sales of the Cypher drug-coated stent were
the major driver behind the unit's performance. Cypher is second
only to Boston Scientific BSX in the drug-coated-stent market.
January 26th:
European Commission Approves Pfizer Inc.’s Exubera(R)
For Treatment Of Type 1 And Type 2 Diabetes
Pfizer Inc said today that the European Commission has approved
Exubera (inhaled human insulin) for the treatment of adults with
type 1 and type 2 diabetes. Exubera is the first non-injectable,
inhalable form of insulin to be approved since the discovery of
insulin in the 1920s, and represents a major advance in diabetes
treatment.
According to the World Health Organization (WHO), diabetes has
reached epidemic proportions and affects approximately 48 million
people in Europe alone. People with diabetes often suffer from
debilitating complications due to uncontrolled blood sugar levels
including heart disease, amputation, blindness and kidney failure.
The direct healthcare costs associated with diabetes are estimated
to be around $286 billion worldwide, with the majority of these
costs linked to treating diabetes-related complications.
Since its discovery more than 80 years ago, insulin has been the
gold standard treatment for diabetes. In order to achieve tight
blood sugar control, insulin is often administered before meals to
mimic the body's natural insulin response to food. Healthcare
providers and patients have been reluctant to initiate or intensify
insulin therapy when it is required due to the need for daily
injections.
Exubera is a fast-acting, dry powder formulation of human insulin
that is inhaled into the lungs via the mouth before meals using a
simple-to-use, hand-held device that does not require batteries or
electricity. The device, which weighs four ounces and is about the
size of a carrying case for a pair of eye glasses, is designed to
deliver an accurate and precise dose of insulin each time it is
used.
January 27th:
Pfizer Inc.’s Cancer Therapy SUTENT(R) Receives FDA Approval
The FDA has simultaneously approved SUTENT (sunitinib malate)
capsules for two types of cancer. SUTENT has been approved to treat
advanced renal cell carcinoma (RCC)*, also known as advanced kidney
cancer. SUTENT has also been approved for malignant gastrointestinal
stromal tumor (GIST), a type of soft-tissue cancer, after disease
progression on or intolerance to imatinib mesylate.
SUTENT is an oral therapy belonging to a new class of multi-kinase
inhibitors that attack cancer by inhibiting both tumor growth and
blood supply. The FDA granted SUTENT priority review in October,
2005.
SUTENT is an oral, multi-kinase inhibitor. Receptor tyrosine
kinases (RTKs) have been implicated in tumor growth, angiogenesis
and the progression of cancer. By inhibiting these RTKs, SUTENT may
impact tumor growth and angiogenesis.
Boston Scientific Corporation Warned By FDA on Plants
Boston Scientific Corporation announced it had received two
communications from the U.S. Food and Drug Administration (FDA). The
first communication was a corporate warning letter related to
procedures, processes and timeliness of the Company's corporate
quality management system. The second communication advised the
Company that an FDA inspection reviewing the manufacture of the
Company's TAXUS(R) paclitaxel-eluting coronary stent system,
Liberte(TM) coronary stent system and Carotid Wallstent(R) system at
the Company's Galway, Ireland manufacturing facility concluded with
no observations reported.
In general, the corporate warning letter notifies the Company
that recent inspections revealed serious regulatory problems at
three facilities and advises top management that its corporate-wide
corrective action plan relating to three prior warning letters
issued to the Company in May and August of 2005 was inadequate. The
letter expresses concerns about the Company's quality systems at six
facilities as well as recent recalls, rather than any specific
product performance issues. The FDA corporate warning letter does
not prevent the continued distribution of products referenced in the
letter, including the TAXUS system. It focuses on issues related to
the review, analysis and reporting of product complaints. The FDA
does not plan to advise hospitals to discontinue using the products
referenced in the letter, including the TAXUS system.
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