|
Other News To Note
(BioWorld Today Via Thomson Dialog NewsEdge) , of Tampa, Fla., received notice from Nasdaq that the company is not in compliance with a Nasdaq requirement for a minimum $50 million market capitalization for continued trading. The company said its capitalization has regained compliance and that must continue for at least 10 consecutive business days before May 15.
? Amylin Pharmaceuticals Inc., of San Diego, reported sales of Byetta rose 15 percent in the first quarter compared to last year, a disappointing result that sent its shares down 10 percent. The company pegged net product sales of Byetta at $158.5 million, far below the approximately $181 million analysts had expected. Overall, Amylin posted a first quarter net loss of $68.8 million, or 51 cents per share, greater than the $49.4 million, and 38 cents per share, that was expected. Overall, net product sales were $178.7 million for the quarter ended March 31, compared to $162 million for the same period in 2007. Shares of Amylin (NADSAQ:AMLN) dropped $3.23, or 10.3 percent, to close at $28.18.
? Avanir Pharmaceuticals, of Aliso Viejo, Calif., was notified by Nasdaq that it has regained compliance with listing standards required to maintain its listing, namely a minimum $50 in market capitalization.
? CardioVascular BioTherapeutics Inc., of Las Vegas, said the Over the Counter Bulletin Board, on which its stock is traded (OTCBB:CVBT), added a temporary "E" to the end of its ticker symbol, indicating the late filing of the company's 10-K annual report. Under OTCBB rules, the company's listing will continue through May 15, provided it files its annual report before that date. The company submitted a Form 8-K April 18 stating it was unable to file its annual report on time.
? Cell Therapeutics Inc., of Seattle, was notified by Nasdaq that the bid price of its common stock has closed below the minimum $1 per share requirement. The company has until Oct. 13, to regain compliance.
? Cerus Corp., of Concord, Calif., has received expanded label claims for use of platelets and plasma treated with the Intercept Blood System to prevent transfusion-associated graft-vs.-host disease (TA-GVHD) in at-risk patients. Those claims allow blood banks in Europe to use the system in place of gamma irradiation for the prevention of TA-GVHD.
? Charlesson LLC, of Oklahoma City, received two Small Business Innovative Research awards from the National Institutes of Health for approximately $1.6 million to support development of a nanoparticle-formulated therapy for eye disease and commercialization of a preclinical genetic animal model for age-related macular degeneration.
? EpiCept Corp., of Tarrytown, N.Y., has received a letter from Nasdaq saying it is not in compliance with the minimum $1 per share requirement. EpiCept will have until Oct. 13, to regain compliance.
? Gene Bridges GmbH, of Heidelberg, Germany, said that Genencor International Inc. USA, a part of Danisco US Inc., of Rochester, N.Y., has completed a commercial license agreement for the use of the Red/ET recombination technology from Gene Bridges. Under the terms of the agreement, Gene Bridges has licensed the Red/ET technology to Genencor for the purpose of genetically engineering recombinant microorganisms for use in industrial applications. No financial details were disclosed.
? Gene Express Inc., of Toledo, Ohio, has signed an agreement with the University of South Florida to license some of its gene expression technology necessary to develop prognostic tests for cisplatin and irinotecan chemoresistance. Some of the specific technology licensed includes the ERCC1 and RRM1 genes. Researchers at the university have discovered a correlation between expression of ERCC1 (excision repair cross-complementing-1) and the survival of patients with non-small-cell lung cancer. Gene Express plans to complete clinical validation for correlation of gene expression vs. chemoresistance for cisplatin treatment by April 2009, and submit a 510K class II prognostic test for cisplatin resistance to the FDA by May 2009.
? iCo Therapeutics Inc., of Vancouver, British Columbia, said it will meet with the FDA May 2 for a pre-investigational new drug meeting for its iCo-009 formulation, an oral formulation of the generic drug Amphotericin B, a clinical path and its proposed 505(b)(2) strategy for iCo-009 will be discussed in the meeting.
? Mobidiag Ltd., of Helsinki, Finland, said its Prove-it Bacteria test set a world record by being able to detect 50 dangerous bacteria simultaneously, including the widespread "superbug" methicillin-resistant Staphylococcus aureus. Currently, diagnostics needed for the antibiotic treatment decision takes two to five days based on blood culturing and subsequent pathogen identification. Using Mobidiag's Prove-it test, the pathogen detection is available one to three days earlier compared to current diagnostics.
? Recordati SpA, of Milan, Italy, said that Orphan Europe, a pharmaceutical group that Recordati acquired in October 2007, has submitted a new drug application to the FDA for Carbaglu for the treatment of hyperammonaemia due to an autosomal genetic disorder resulting in the deficiency of the liver enzyme N-acetylglutamate synthase. Carbaglu was granted orphan drug status in Europe in 2000 and the same status in the U.S. in 1998. It received FDA fast-track designation in May 2007.
? Renovis Inc., of South San Francisco, said that Institutional Shareholder Services, a leading proxy advisory firm, has recommended that Renovis stockholders vote for the merger agreement with Evotec AG, of Hamburg, Germany, at the special stockholders meeting set for May 1. In the proposed merger, each share of Renovis common stock will be converted into the right to receive the equivalent of 1.0542 Evotec ordinary shares.
? Savient Pharmaceuticals Inc., of East Brunswick, N.J., said no new clinical data are being required for submission of a biologics license application for Puricase (pegloticase) for treatment-failure gout, based on results of its pre-BLA meeting with the FDA. An agreement was reached on requirements for chemistry, manufacturing and controls data and for release testing of the commercial drug supply.
? Starpharma Holdings Ltd., of Melbourne, Australia, said that recent studies have shown that SPL7013, the active ingredient in its topical microbicide VivaGel, inhibits clinically relevant strains of the human papillomavirus in laboratory tests. Starpharma CEO, Jackie Fairley said in a news release that it is possible that VivaGel has potential for reducing the risk of genital HPV infection, the most common sexually transmitted infection in the U.S.. The company's lead pharmaceutical development product is VivaGel(R) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
? Strativa Pharmaceuticals, of Woodcliff Lake, N.Y., the proprietary products division of Par Pharmaceutical Companies Inc. said its development partner, BioAlliance Pharma, of Paris, reported preliminary, top-line results for a Phase III study of Loramyc (miconazole Lauriad) mucoadhesive buccal tablets, in the treatment of oropharyngeal candidiasis (OPC) showing it met its primary endpoint of noninferiority to Mycelex Troche (clotrimazole) in the complete resolution of signs and symptoms of OPC. Loramyc, which is approved in Europe and currently being marketed in France, is an antifungal delivered in a mucoadhesive buccal tablet designed to enable local once-daily dosing. The company said a new drug application could be filed as early as the second half of this year.
? Vertex Pharmaceuticals Inc., of Cambridge, Mass., has been hit with a shareholder class-action lawsuit filed in the U.S. District Court for the District of Massachusetts, according to the law firm representing plaintiffs, Schiffrin Barroway Topaz & Kessler LLP. The complaint alleges that the company misrepresented results from the PROVE 2 trial of its hepatitis C drug, telepravir (VX-950). Patients taking VX-950 only experienced a 6 percent advantage as compared to 16 percent in the previous study, the suit alleges. The company failed to indicate the findings of PROVE 2 when the results became known, and Vertex stock fell more than 16 percent on news of the negative study results, the law firm said. Plaintiffs are seeking to recover damages on behalf of the class.
?
?
Copyright ? 2008 Thomson BioWorld, All Rights Reserved.
[ Back To TMCnet.com's Homepage ]
|
INDUSTRIES
INDUSTRIES
Find Solutions for Enterprises, SMBs & Service Providers at the INTERNET TELEPHONY Conference and EXPO East, February 2-4, 2009. Miami, Florida.
