FDA Calendar Updates for Wyeth (NYSE:WYE), Isis Pharma (NASDAQ:ISIS) and others
Pasadena, CA, United States, 05/08/2009 - There are new updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.
Wyeth (NYSE:WYE), Pfizer (NYSE:PFE): WYE announced that the FDA granted a priority (six-month) review for the Company’s pending BLA for Prevnar (Pneumococcal 13-valent Conjugate Vaccine) which was filed at the end of March.
Savient Pharma (NASDAQ: SVNT): SVNT announced that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09.
Amarin Corp. (NASDAQ:AMRN): AMRN announced today that it has agreed to a Special Protocol Assessment (SPA) with the FDA for its planned Phase 3 registration clinical trial of AMR101 (ethyl-EPA) in patients with hypertriglyceridemia (very high triglyceride levels).
Salix Pharma (NASDAQ: SLXP): Salix provided an update on the pending NDA for Sanvar (vapreotide), which is scheduled for a FDA Panel Review on 5/19/09 (the Gastrointestinal Drugs Advisory Committee).
Isis Pharma (NASDAQ:ISIS), Genzyme (NASDAQ:GENZ): Topline data is expected during 2Q09 from a Phase 3 clinical trial of mipomersen in the treatment of a genetic disorder (homozygous familial hypercholesterolemia) causing very high levels of LDL cholesterol (LDL-C).
Somaxon Pharma (NASDAQ:SOMX): SOMX provided clarity on the Complete Response Letter from 2/25/09 (CRL) for its experimental insomnia drug Silenor. Following recent discussions with the FDA, SOMX expects to submit additional analyses during 2Q09 from its adult sleep maintenance clinical trial along with other important information that the Company believes can support a decision by the FDA on the CRL.
Disclosure: No positions.
For more on these news developments see the news report here: http://www.biomedreports.com
Informed investors use the exclusive FDA and Clinical Trial Calendars to stay ahead of the market by knowing when FDA approvals are scheduled.
Access to those calendars is available here: http://biomedreports.com/component/content/article/548.html
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
For more biomedical sector and investment news, go to BiomedReports.Com
Disclosure: No positions.
Certain sections of this report contain forward-looking statements that are based on our reporters’ expectations, estimates, projections and assumptions. Words such as “expects,” “anticipates,” “plans,” “believes,” “scheduled,” “estimates” and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, FDA announcements, trial and drug approvals, and company stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors including but not limited to the status or outcome of legal and/or regulatory proceedings.
All forward-looking statements speak only as of the date of this report or, in the case of any document incorporated by reference, the date of that document. All subsequent written and oral forward-looking statements attributable to the company or any person acting on the company’s behalf are qualified by the cautionary statements in this section. BiomedReports.Com does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this report.
- Contact Information
- M.E. Garza
- Contact via E-mail
This news content may be integrated into any legitimate news gathering and publishing effort. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.