December 5th:
Boston Scientific Corporation Proposes To Acquire Guidant
Corporation
Boston Scientific Corporation announced that it is proposing to
acquire all the outstanding shares of Guidant Corporation for a
combination of cash and stock worth $72 per Guidant share. The
proposed transaction is valued at approximately $25 billion, a
premium of approximately $3 billion to the current valuation of the
transaction between Johnson & Johnson and Guidant. Assuming that
Boston Scientific and Guidant enter into an agreement by the year
end, the proposed transaction might close in the first quarter of
2006.
Boston Scientific Announces Worldwide Recall of Stainless
Steel Greenfield® Vena Cava Filters Manufactured Before March 10,
2004
Boston Scientific Corporation announced that it is voluntarily
recalling all Stainless Steel Greenfield® Vena Cava Filters with
12Fr Femoral Introducer Systems manufactured before March 10, 2004.
This recall does not affect vena cava filters that have been
implanted in patients. This recall includes only the Stainless Steel
Greenfield® Vena Cava Filter with 12Fr Femoral Introducer Systems
manufactured prior to March 10, 2004. All unused devices with a “use
before date” prior to March 2007 are to be returned to Boston
Scientific. The total number of devices involved in this recall is
estimated at 18,000.
The Company is initiating this recall because of reports of
detachment at the bond between the carrier capsule and the outer
sheath of the filter’s delivery system during the implant procedure.
If the carrier capsule should detach during an implantation
procedure, there is a risk of cardiac and pulmonary embolization.
Potential adverse events include serious patient injury or death.
December 6th:
Roper Industries Acquires Medtec
Roper Industries announced that it has acquired Medtec, Inc., of
Orange City, Iowa for approximately $150 million in cash.
Medtec designs, develops, and distributes technologies essential
for accurate diagnosis and treatment for cancer care. Medtec
products include image-guided therapy software, patient positioning
devices, and related products and accessories.
Dec 7th:
Johnson & Johnson Seen Walking Away From Guidant Corporation
Johnson & Johnson, facing a rival bid for Guidant Corp. from
Boston Scientific, on Tuesday said it was committed to the
transaction but failed to raise its offering price, signaling to
many on Wall Street that it may walk away from the deal. J&J issued
the statement a day after Boston Scientific Corp. made a surprise
$25 billion offer for Guidant -- topping J&J's recently reduced
price of $21.5 billion, which had been worked out with Guidant last
month. J&J said its offer represents the "full and fair value" for
Guidant, and that it expects Guidant shareholders to vote on its bid
at a meeting expected to take place in the first quarter of 2006.
December 8th:
Boston Scientific Corporation Announces Worldwide Recall Of
Flextome Cutting Balloon(R) Systems
Boston Scientific Corporation announced that it is voluntarily
recalling all Flextome Cutting Balloon® Device Monorail® Delivery
System and Peripheral Cutting Balloon® Microsurgical Dilatation
Device Small Monorail® Delivery System. No other Boston Scientific
Cutting Balloon products are affected by this recall.
The Company is initiating this recall because it has determined
through complaints and testing that the distal shaft of the catheter
may separate during withdrawal of the device. A shaft separation may
prolong the procedure or require additional surgery. A total of
eight complaints involving patients have been received by the
Company, of which three required surgery. Today's action does not
affect patients who have already received treatment with the
recalled devices because the potential problem occurs during the
procedure. The total number of devices involved in this recall is
estimated at 40,000.
AstraZeneca And Protherics PLC Clinch $338 Million Drug Deal
Protherics, the biopharmaceutical company focused on critical
care and oncology, today announces an agreement with AstraZeneca for
the global development and commercialisation of Protherics'
anti-sepsis product CytoFab(TM).
AstraZeneca will be responsible for developing CytoFab(TM), an
anti-TNF-alpha polyclonal antibody fragment (Fab) product, as a
treatment for TNF-alpha mediated diseases in man, with an initial
target indication of severe sepsis. Sepsis is a life-threatening
condition resulting from uncontrolled severe infections which
affects an estimated three million people a year worldwide. Under
the terms of the agreement, AstraZeneca will undertake all clinical
development work (phase III to be launched) for CytoFab(TM) and
Protherics will be primarily responsible for bulk drug
manufacturing, including the supply of clinical trial material. The
agreement will become effective upon the expiration of the
Hart-Scott-Rodino waiting period in the US, which is anticipated
early in 2006.
December 9th:
Medtronic, Inc. Provides Update on U.S. Obesity Trial;
SHAPE Trial Does Not Meet Efficacy Endpoint
Medtronic, Inc. announced today that the preliminary results of
the Screened Health Assessment and Pacer Evaluation, or SHAPE trial,
did not meet the efficacy endpoint of a difference in mean excess
weight loss at one year. The SHAPE trial is a U.S. multi-center,
double-blind randomized controlled trial of Implantable Gastric
Stimulation (IGS) for the management of obesity. This trial was
designed to detect the difference in excess weight loss between
patients who received IGS therapy and a placebo group who did not.
Merck in Fresh Trouble
Shares of Merck & Co. fell after the after the New England
Journal of Medicine said authors of a study funded by Merck failed
to disclose that three additional patients in a 2000 clinical study
suffered heart attacks while using the now-withdrawn painkiller. The
editorial, written by the journal's editor in chief, Dr. Jeffrey M.
Drazen, executive editor Dr. Gregory D. Curfman and managing editor
Stephen Morrissey, also alleges the study's authors deleted other
relevant data before submitting their article for publication.
"Taken together, these inaccuracies and deletions call into question
the integrity of the data on adverse cardiovascular events in this
article," the doctors wrote. Excluding the three heart attacks "made
certain calculations and conclusions in the article incorrect."
The findings of what became known as the VIGOR study have been a
key part of testimony in the three product liability trials to date
over the withdrawn drug, including one in which a federal jury in
Texas began deliberations Thursday afternoon. The research was
published more than a year after the Food and Drug Administration
approved Vioxx in May 1999. The study was intended to compare
whether Vioxx caused more stomach ulcers and bleeding among patients
with rheumatoid arthritis than for those using the older, cheaper
anti-inflammatory naproxen. Over an average nine-month period, Vioxx
did score better on that count, but the study also showed there were
a greater number of heart attacks among Vioxx users. In the article,
Merck explained differences found in that study by saying naproxen
is cardioprotective.
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