|Biogen Receives Conditional Approval For FAMPYRA. Neoprobe Comments On Regulatory Approval.|
|By Staff and Wire Reports|
|Monday, 25 July 2011 20:04|
Biogen Idec Inc (NASDAQ:BIIB) announced it has received conditional approval from the European Commission for FAMPYRA (prolonged-release fampridine tablets) to improve walking in adult patients with multiple sclerosis (MS) who have walking disability (Expanded Disability Status Scale 4-7).
FAMPYRA is the treatment that addresses this unmet medical need with demonstrated efficacy in people with all types of MS.1 FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs.
FAMPYRA was developed and is being commercialized in the United States by Acorda Therapeutics, Inc. (NASDAQ:ACOR).
Neoprobe Corp. (AMEX:NEOP) announced on July 22, 2011, it was disclosed in a private company press release that the U.S. Food and Drug Administration (FDA) had approved use of sulfur colloid (Kit for the Preparation of Technetium Tc99m Sulfur Colloid) to locate lymph nodes in breast cancer patients.
This approval was stated to be based on a literature review of past clinical trials. Importantly, in gaining approval, this statement indicates that the performance of sulfur colloid was compared only to vital blue dye alone. The use of the vital blue dye as a comparator to support regulatory approval strategy is the same with which Neoprobe seeks FDA approval for Lymphoseek.
Neoprobe believes that such an approval of sulfur colloid on this basis validates Neoprobe’s regulatory approach. Further, as opposed to a literature-based trial review conducted by others, Neoprobe will seek approval on the basis of comparison to vital blue dye in carefully designed, controlled and well executed clinical trials meeting current regulatory standards.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex:ANX) today announced the appointment of Gregory D. Gorgas as Senior Vice President, Commercial.
Amgen (NASDAQ:AMGN) today announced that it will report its second quarter financial results on Friday, July 29, 2011 before the opening of the U.S. financial markets.
Anavex Life Sciences Corp. ("Anavex") (OTCBB: AVXL) is pleased to provide a summary of the first of two poster presentations at the Alzheimer's Association International Conference (AAIC) held in Paris, entitled "The novel aminotetrahydrofuran derivative ANAVEX 2-73 attenuated GSK-3beta and Tau hyperphosphorylation in a nontransgenic Alzheimer's disease model in mice."
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced today that the last patient has completed the randomized portion of its Phase 3 clinical trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain, signifying completion of the trial.
For the first time, Eli Lilly and Company (NYSE:LLY) employees worldwide can donate to more than 800 grassroots projects across the globe and have their donations matched by the Eli Lilly and Company Foundation—doubling the value and impact of each employee's charitable contribution.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today its results for the second quarter and six months ended June 30, 2011.
Pharmasset, Inc. (Nasdaq:VRUS), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the quarter ended June 30, 2011.
QIAGEN N.V. (NASDAQ:QGEN; Frankfurt Prime Standard: QIA) today announced results of operations for the second quarter and first half of 2011, delivering improved performance and solid gains in free cash flow.
Sunshine Biopharma Inc. (OTCBB: SBFM) a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed a study in which the mechanism of clearance of the Company's new drug, Adva-27a, was analyzed using human liver microsomes in vitro.
Waters Corporation (NYSE:WAT) today unveiled new technology solutions for increasing clinical laboratory efficiencies including the first CE Marked LC/MS/MS integrated solution for the quantification of everolimus (Certican®).