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Cardiome Provides Clinical Update
Cardiome Pharma Corp.
(NASDAQ: CRME / TSX: COM) today announced that representatives from its
co-development partner Astellas Pharma US, Inc. and Cardiome have met with
the U.S. Food & Drug Administration (FDA) to discuss the "refusal to file"
(RTF) letter received on May 30, 2006 for the New Drug Application (NDA)
for RSD1235 (iv), an investigational new drug for the acute conversion of
atrial fibrillation.
The meeting was requested by Astellas and Cardiome in order to explore
the issues referenced by the FDA within the RTF letter, and to discuss
appropriate measures which can be taken to resolve those issues. Astellas
and Cardiome have dedicated substantial resources within their clinical and
regulatory groups to conducting a comprehensive re-review and audit of the
NDA documents and associated databases. The amended NDA will be
re-submitted following completion of this process.
"We are pleased with how the meeting went with the FDA," said Dr.
Charles Fisher, Executive Vice President and Chief Medical Officer of
Cardiome. "Astellas and Cardiome will reflect on the discussion and,
following consultation with our partner, expect to be in a position to
provide further guidance to investors in the near term regarding the timely
and accurate re-submission of the NDA for RSD1235 (iv)."
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug
development company with two clinical drug programs focused on atrial
arrhythmia (intravenous and oral dosing), and a pre-clinical program
directed at improving cardiovascular function.
RSD1235 (iv) is the intravenous formulation of an investigational drug
being evaluated for the acute conversion of atrial fibrillation (AF).
Positive top-line results from two pivotal Phase 3 trials for RSD1235 (iv),
called ACT 1 and ACT 3, were released in December 2004 and September 2005.
An additional Phase 3 study evaluating patients with post-operative atrial
arrhythmia, called ACT 2, and an open-label safety study evaluating
recent-onset AF patients, called ACT 4, are ongoing.
RSD1235 (oral) is being investigated as a chronic-use oral drug for the
maintenance of normal heart rhythm following termination of AF. A Phase 2a
pilot study for RSD1235 (oral) was initiated in December 2005.
Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ
National Market (CRME). Further information about Cardiome can be found at
http://www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this press release contain forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995 or forward-looking information under applicable Canadian
securities legislation that may not be based on historical fact, including
without limitation statements containing the words "believe", "may",
"plan", "will", "estimate", "continue", "anticipate", "intend", "expect"
and similar expressions. Such forward-looking statements or information
involve known and unknown risks, uncertainties and other factors that may
cause our actual results, events or developments, or industry results, to
be materially different from any future results, events or developments
expressed or implied by such forward-looking statements or information.
Such factors include, among others, our stage of development, lack of
product revenues, additional capital requirements, risk associated with the
completion of clinical trials and obtaining regulatory approval to market
our products, the ability to protect our intellectual property, dependence
on collaborative partners and the prospects for negotiating additional
corporate collaborations or licensing arrangements and their timing.
Specifically, certain risks and uncertainties that could cause such actual
events or results expressed or implied by such forward-looking statements
and information to differ materially from any future events or results
expressed or implied by such statements and information include, but are
not limited to, the risks and uncertainties that: we may not be able to
successfully develop and obtain regulatory approval for RSD 1235 (iv) in
the treatment of atrial fibrillation or any other current or future
products in our targeted indications; our future operating results are
uncertain and likely to fluctuate; we may not be able to raise additional
capital; we may not be successful in establishing additional corporate
collaborations or licensing arrangements; we may not be able to establish
marketing and sales capabilities and the costs of launching our products
may be greater than anticipated; we rely on third parties for the continued
supply and manufacture of RSD 1235 (iv) and RSD (oral) and we have no
experience in commercial manufacturing; we may face unknown risks related
to intellectual property matters; we face increased competition from
pharmaceutical and biotechnology companies; and other factors as described
in detail in our filings with the Securities and Exchange Commission
available at http://www.sec.gov and the Canadian securities regulatory authorities
at http://www.sedar.com. Given these risks and uncertainties, you are cautioned
not to place undue reliance on such forward-looking statements and
information, which are qualified in their entirety by this cautionary
statement. All forward-looking statements and information made herein are
based on our current expectations and we undertake no obligation to revise
or update such forward-looking statements and information to reflect
subsequent events or circumstances, except as required by law.
Cardiome Pharma Corp.
http://www.cardiome.com
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