Roche's new results look promising for patients with certain cancers Print E-mail
By Jude Santos   
Friday, 15 May 2009 11:34
More than 500 scientific abstracts to be presented across 20 types of cancers. Results could significantly improve the way cancer is treated for patients with inoperable stomach cancer; advanced melanoma; lung and breast cancers.Roche (OTC:RHHBY) today provided an overview of results from studies that further the company’s approach to developing targeted medicines for people with cancer, a diagnosis that will affect more than one in three people during their lifetime. Results from studies involving the company’s approved and investigational treatments will be presented during the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place May 29 through June 2 in Orlando, USA.
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FDA, Clinical Trial Calendars: Prevacid Goes OTC, Swine Flu Test Print E-mail
Thursday, 14 May 2009 19:15
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. Cadence Pharma (NASDAQ:CADX): On 5/14/09, CADX announced the 505(b)(2) NDA submission for Acetavance (the Company's proprietary intravenous formulation of acetaminophen) for the treatment of acute pain and fever in adults and children. If approved, Acetavance would become the first new intravenous analgesic approved in the U.S. in more than 20 years and the only approved intravenous agent for the treatment of fever in this country.
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FDA forced changes are likely to cost General Mills "millions and million of dollars" Print E-mail
By Austin Pherb   
Thursday, 14 May 2009 03:00
(Updated) "It think the FDA got it wrong on this one," supermarket expert Phil Lempert told Advertising Age. He pointed to the inevitable chest pounding associated with a new administration and FDA leadership. "To go after a major brand like Cheerios is [for] headlines that say to everybody 'We're doing our job,'" Mr. Lempert said. Federal regulators are scolding the maker of Cheerios, saying it made inappropriate claims about the popular cereal's ability to lower cholesterol and treat heart disease.
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Cell Therapeutics set to reduce headcount and present Phase III Data Print E-mail
By Lauran Neergaard   
Thursday, 14 May 2009 03:00
Cell Therapeutics, Inc. (Nasdaq: CTIC) announced that, as previously discussed in a press release on February 27, 2009, it is closing its Bresso, Italy operations and has reached agreement with the employee union on a severance package. The agreement relates to a reduction of CTI's total headcount in Italy by 56 positions in the immediate months, and is expected to save CTI approximately $14 million in annual operating expenses moving forward. The Bresso facility was used for pre-clinical research and was underutilized due to CTI's focused business model on late stage development and commercialization. CTI will continue to assist in searching for career opportunities for the Bresso employees. CTI also continues to support the employee's efforts to establish a local management buy-out for the facility but the closure of the facility and operations will start May 18, 2009.
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10 Extreme Trades on Pending Clinical Trial Results Print E-mail
Wednesday, 13 May 2009 20:13
As a follow-up to my recent article on nine extreme FDA trades of pending new product decisions among small and micro-cap companies, I have examined the BioMedReports.com Clinical Trial Calendar database to find companies with market caps below $250M which have pending Phase 2 or 3 clinical trial results expected before the end of 2009. Below is a sample of 10 stocks meeting this criteria from the database of 111 entries included in the BioMedReports.com Clinical Trial Calendar, which is in addition to the 120 entries in the FDA Calendar database as of 5/13/09.
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FDA, Clinical Trial Calendar Updates: Insmed, Jazz Pharma Await Key Results Print E-mail
Wednesday, 13 May 2009 17:56
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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FDA, Clinical Trial Calendar Updates: AMAG, IMMU Print E-mail
Tuesday, 12 May 2009 16:23
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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Encouraging Phase III Results for ARCA Biopharma, Inc. (NASDAQ:ABIO) Print E-mail
By Michael Vlaicu   
Tuesday, 12 May 2009 07:18
Heart failure has always been one of the predominant fatal human conditions, today I focus on a company which has developed a treatment with encouraging results against this, often fatal, disease.Key Facts: Heart failure becomes more common with increasing age. About 1 in 35 people aged 65-74 years have heart failure. This increases to about 1 in 15 of people aged 75-84 years, and to just over 1 in 7 people aged 85 years and above. It is uncommon in younger people.
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Cell Therapeutics Sells $20M in Stock, Warrants Print E-mail
Monday, 11 May 2009 17:47
After the market close, Cell Therapeutics (NASDAQ:CTIC) announced the sale of $20M of its common stock at $1.25 per share along with warrant coverage to a single institutional investor. CTIC plans to use $17.8M in cash on hand and/or raised through this sale to pay for its anticipated 'Modified Dutch Auction' tender offer to retire between $83.2-89.2 million of convertible debt within an expected range of $250-300 per $1,000 par value of the bonds. The sale announced today includes 30% warrant coverage on the $20M offering price with an exercise price of $1.40 per warrant share for total additional proceeds to CTIC of up to $6.7M if all of the warrants are exercised before their termination date of 5/11/14. Rodman & Renshaw was the exclusive agent in this transaction and the deal today follows a sale announced last month through which CTIC raised $23.8M through the sale of newly-issued preferred stock to a single institutional investor and the exercise of common stock warrants associated with the transaction. All shares of preferred stock in the deal were subsequently converted into common stock by the investor so that CTIC has no preferred stock outstanding at this time.
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FDA, Clinical Trial Calendar Updates: AZN, IMGN, MIPI, MELA Print E-mail
Monday, 11 May 2009 15:07
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. AstraZeneca (NYSE:AZN): On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death.
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