Recently, Acorda Therapeutics Inc. (ACOR) announced that the U.S. Food and Drug Administration (FDA) has cleared its oral drug Ampyra (dalfampridine) which aims to improve walking speed in patients suffering from multiple sclerosis (MS). The company expects to launch the drug in the United States in March 2010. Ampyra is the first drug to get FDA approval for treating walking impairment in MS patients.

Ampyra, previously known as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously referred to as fampridine. The drug enjoys orphan drug designation from the U.S. agency, thereby providing it with seven years of market exclusivity.

Ampyra will be manufactured under a license and supply agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (ELN). However, Ampyra will be marketed and distributed in the U.S. by Acorda.

Ampyra was found to be effective in patients with all four major

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Updates for: Bovie Medical Corporation (AMEX:BVX), and Acorda Therapeutics (NASDAQ:ACOR)

The following is a list of companies which includes the company name, ticker symbol, decision date, and the lastest updated description and notes. Each entry includes a summary of the pending regulatory or clinical trial catalyst event and other relevant information such as FDA Advisory Panel Meetings or previous decisions, if applicable.

Pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings), Pending complete response letter (CRL) re-submissions to the FDA, Pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval, Pending mid and early-stage clinical trial results for small / micro-cap companies. Bovie Medical Corporation

(AMEX:BVX)

On 7/22/09, BVX  (AMEX:BVX) announced a 510(k) submission to the FDA seeking pre-market clearance for the Company’s Polarian Seal-N-Cut vessel sealing line of hybrid

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Dr Stock Pick HOT News & Alerts!

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FREE Daily Stock Alerts From DrStockPick.com

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Thursday October 15, 2009

DrStockPick.com Stock Report!

PWRM, ACOR, AQNM

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PWRM, Power 3 Medical Products Inc, PWRM.OB

Power3 Medical Products, Inc. is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. Power3’s patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Diagnostic tests are targeted toward markets with critical unmet needs in areas including neurodegenerative disease (NuroPro) and breast cancer (BC-SeraPro). Power3 expects to complete phase

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For Immediate Release

Chicago, IL - May 7, 2009 - Zacks Equity Research picks Acorda Therapeutics, Inc. (ACOR) as Bull of the Day and The Corporate Executive Board (EXBD) as Bear of the Day. In addition, the analysts at Zacks Equity Research discuss the latest on Amazon.com (AMZN), Pearson Plc (PSO) and John Wiley & Sons (JW.A).

Full analysis of all these stocks is available at: http://at.zacks.com/?id=2678

Bull of the Day

Acorda Therapeutics, Inc. (ACOR) received some very good news on May 6, 2009 when the U.S. FDA informed the company that the new drug application (NDA) for Fampridine-SR was accepted. The news comes only two weeks after the re-filing of the NDA on April 23, 2009.

However, the biggest surprise with the acceptance off the NDA was that the FDA also granted Acorda a priority review for the application. We note this was an independent decision by

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We highlight Acorda Therapeutics, Inc. (ACOR), Biogen Idec, Inc. (BIIB), Pfizer, Inc. (PFE), Sanofi-Aventis SA (SNY) and Wyeth (WYE).We upgraded shares of Acorda Therapeutics, Inc. (ACOR) the day after the FDA issued the RTF ("refuse to file") letter on April 1, 2009. At that time the shares were hit hard -- down to the $18 level -- and we noted that we "Finally got our buying opportunity." We previously had a Hold rating on the name, waiting for a pullback before we recommended clients get in.Over the past few months we have become increasingly confident that the application for Fampridine-SR looks strong -- from a clinical data standpoint. The application contains data from a comprehensive development program assessing the safety and efficacy of Fampridine-SR, including two phase III trials that involved 540 people with MS and were conducted under Special ...

For Immediate Release

Chicago, IL - April 24, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: The Coca-Cola Company (KO), Acorda Therapeutics, Inc. (ACOR), Royal Caribbean (RCL), United Parcel Service, Inc. (UPS) and Robert Half International Inc. (RHI).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Thursday's Analyst Blog:

Coca-Cola Gets Innocent

The Coca-Cola Company (KO) is investing £30 million ($44 million) for a minority stake of between 10% and 20% in Innocent Drinks, a U.K.-based maker of fruit smoothies. Innocent sells about 2 million smoothies a

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Buy Rated Acorda Resubmits Fampridine-SR NDAThis morning, Acorda Therapeutics, Inc. (ACOR) announced it had resubmitted a New Drug Application (NDA) for Fampridine-SR to the U.S. FDA. Fampridine-SR is a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).We remind investors that Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on March 30, 2009, which cited the need to correct "format issues" and requested additional supporting information on a fed/fasting study before the NDA could be accepted for review. Acorda management held subsequent discussions with the FDA, and now believes the filing this morning addresses all the outstanding issues with the RTF letter.Acorda's stock was punished hard in late March 2009 on the news that the NDA was rejected with an RTF letter. At that time, we advised investors to use the significant sell-off ...

On March 31, 2009, Acorda Therapeutics Inc. (ACOR) received a "refuse to file" (RTF) letter from the U.S. FDA regarding its new drug application (NDA) for Fampridine-SR, the company's novel therapy designed to improve walking ability in people with multiple sclerosis (MS).According to management, the FDA raised three issues in the RTF letter. The first issue raised by the FDA notes a "format issue" regarding the electronic common technical document (eCTD) submission, and requested that some of the data in the filing be reformatted.The FDA also asked Acorda for additional data relating to a fed/fasting study and some analytical information from the clinical program on Fampridine-SR. Our best guess is that management can compile the necessary fed/fast and analytical data and re-file the NDA in six months. Management plans to meet with the FDA sometime in the next 30 days to discuss the RTF ...