December 12th:
Merck & Co., Inc.: Hung Jury in First Federal VIOXX(R) Product
Liability Trial
In a press release, Merck & Co., Inc. says it is disappointed a
federal court jury in Houston, Texas could not return a verdict in
Plunkett v. Merck and is prepared for a retrial, if that becomes
necessary. "We presented evidence that there is no medical or
scientific evidence showing short-term use of VIOXX increases the
risk of heart attack and no evidence that it contributed in any way
to the unfortunate death of Richard Irvin," said Philip Beck, of the
law firm of Bartlit Beck, Merck's lead trial lawyer in the case.
"Mr. Irvin only took VIOXX for less than a month. He suffered
multiple long-standing risk factors for a heart attack including
partially clogged arteries. We believe that Mr. Irvin would have
suffered a heart attack when he did, whether he was taking VIOXX or
not."
December 13th:
FDA staff seeks more info on Merck rotavirus vaccine
FDA needs more information from Merck & Co. Inc. before they can
finish reviewing the effectiveness of an experimental vaccine to
help prevent severe diarrhea in children, according to documents
released on Tuesday. The oral vaccine against rotavirus appeared
safe compared with a placebo, but long-term, post-approval studies
of potential risks may warrant consideration, Food and Drug
Administration staff wrote in a summary prepared for Wednesday's
meeting of an agency advisory panel.
GlaxoSmithKline And Vertex Pharmaceuticals
Incorporated Announce New Collaboration To Develop And Commercialize
VX-409, A Novel Compound For The Treatment Of Pain
GlaxoSmithKline and Vertex Pharmaceuticals Incorporated announced
that they have entered into a new agreement to develop and
commercialize VX-409, Vertex's novel, subtype selective sodium
channel modulator for the treatment of pain. VX-409 is the first of
a new class of agents targeting specific pain signals in nerve
cells. Under the terms of the agreement, GSK will have the exclusive
right and license to develop and commercialize VX-409 and back-up
compounds worldwide. Vertex will receive a $20 million up-front
payment and could receive up to an additional $385 million in
development and sales threshold milestone payments based on the
development of VX-409 and back-up compounds in major pharmaceutical
markets across a range of indications. GSK will also pay Vertex
royalties on annual net sales.
December 15th:
Amgen to Acquire Abgenix for $22.50 Per Share
Amgen , the world's largest biotechnology company, and Abgenix,
Inc. , a company specializing in the discovery, development and
manufacture of human therapeutic antibodies, today announced that
they have signed a definitive merger agreement under which Amgen
will acquire Abgenix for approximately $2.2 billion in cash plus the
assumption of debt. Under the terms of the agreement, shareholders
of Abgenix will receive $22.50 in cash per common share. The
acquisition of Abgenix provides Amgen with full ownership of one of
its most important advanced pipeline products, panitumumab. Working
closely with Abgenix under a co-development agreement that Amgen
assumed as a result of its acquisition of Immunex Corporation in
2002, Amgen has led the development and commercialization strategy
for panitumumab.
Endologix Announces Limited Voluntary Recall of Powerlink System
Delivery Catheter
Endologix, Inc. announced that it is voluntarily conducting a
limited product recall of selected Powerlink(R) System delivery
catheters marketed in the U.S. This action does not include the
Powerlink stent grafts that have been implanted in patients. In
addition, it does not include the large diameter 34 mm Powerlink
System being evaluated under an investigational device exemption or
Powerlink Systems sold outside of the U.S. Endologix has notified
the U.S. Food and Drug Administration (FDA) Los Angeles District
Office. Endologix is initiating this action as a result of its
ongoing comprehensive analysis of three recent reports of tip
separation from the catheter sheath inner core during procedures.
December 16th:
Novartis Corporation Halts Cholesterol Drug Development
Drug maker Novartis will book a $266-million charge in the fourth
quarter after stopping clinical trials of an experimental statin or
cholesterol-lowering drug, the company said on Friday. Test results
had shown the compound, a lipid-lowering agent called NKS104, was no
longer competitive enough for Novartis to warrant spending more
money on bringing it to the market.
FDA Advisory Committee has Positive Opinion on Safety Of
Zostavax(TM), Merck & Co., Inc. Investigational Vaccine For
Shingles, In Adults Aged 60 And Older
Merck & Co., Inc. announced that the U.S. Food and Drug
Administration's (FDA) Vaccines and Related Biological Products
Advisory Committee agreed that the extensive data from clinical
trials in more than 40,000 people support the efficacy and safety of
ZOSTAVAX(TM) (zoster vaccine live (Oka/Merck)), the Company's
investigational vaccine, to prevent shingles in adults aged 60 and
over.
3M to Acquire Siemens Ultrasound's Flexible Circuit Manufacturing
Operation
3M announced it has entered into an agreement to acquire the
Siemens Ultrasound Division's flexible circuit manufacturing line in
Canoga Park, Calif. The Siemens Ultrasound Division produces
flexible interconnect circuits that provide electrical connections
between components in electronics systems used primarily in the
transducers of ultrasound machines. "Adding Siemens' flexible
circuits expands 3M's business in the ultrasound and medical imaging
markets," said Frank R. Little, division vice president, 3M
Electronic Solutions Division. 3M Electronics provides flex circuits
used in medical devices and diagnostics, printer, and cell phone
applications, as well as many other products for the electronics
industry.
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