FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD
... First proton pump inhibitor (PPI) with a Dual delayed Release(TM) (DDR) formulation DEERFIELD, ... (FDA) approved KAPIDEX(TM) (dexlansoprazole) delayed release capsules for the once-daily, oral ... the first proton pump inhibitor (PPI) with a Dual delayed Release(TM) (DDR) formulation designed to provide ...Protein Sciences Responds to Emergent BioSolutions Lawsuit
... meeting instead of forcing a vote on the transaction. Following the delayed shareholder meeting, PSC's board of directors re-affirmed that it remained ... to trying to complete a transaction with EBS. In a meeting following the delayed shareholder meeting, EBS now complained to PSC that the Proxy Statement ...Vion Reports 2008 First Quarter Results
... approval for its products, particularly Cloretazine(R) (VNP40101M), delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to ...JCI table of contents: April 22, 2008
... affect the production of sex hormones and can cause either premature or delayed puberty as well as infertility. New data, generated in mice by Jacques ... under certain conditions, the formation of a thrombus in mice was delayed in the absence of CD36 and the thrombi that formed contained fewer ...Vion Pharmaceuticals Files Plan With Nasdaq
... approval for its products, particularly Cloretazine(R) (VNP40101M), delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to ...Raptor Pharmaceuticals Corp. Enters Agreements to Advance Clinical Pipeline
... of California, San Diego ("UCSD") around the use of Cysteamine, and delayed Release Cysteamine ("DR Cysteamine") for the treatment of Non-alcoholic ... the Company's ability to initiate a Phase 2a study of Cysteamine or delayed Release Cysteamine in NASH patients in 2008, develop an oral formulation ...Vion Reports 2007 Fourth Quarter and Year-End Results
... approval for its products, particularly Cloretazine(R) (VNP40101M), delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to ...Vion Pharmaceuticals to Implement a One-for-Ten Reverse Stock Split
... Vion's potential inability to obtain regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to ...Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
... Vion's potential inability to obtain regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to ...Vion Pharmaceuticals Holds Special Meeting of Stockholders
... Vion's potential inability to obtain regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to ...Vion Pharmaceuticals Adds William Hahne, M.D. to Senior Management Team
... Vion's potential inability to obtain regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to ...Vion Pharmaceuticals to Present at 20th Annual Bear Stearns Healthcare Conference
... Vion's potential inability to obtain regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty ...Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
... Vion's potential inability to obtain regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable ... accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty ...KV Pharmaceutical Announces Stockholder Action to Amend By-Laws is Invalid
... as a result of so-called authorized-generic drugs; (7) new product development and launch, including the possibility that any product launch may be delayed or that product acceptance may be less than anticipated; (8) reliance on key strategic alliances; (9) the availability of raw materials and/or ...Telik Announces Second Quarter 2009 Financial Results
... to differ materially from those indicated by these forward-looking statements, including, among others, if clinical trials of TELINTRA or TELCYTA are delayed or unsuccessful, Telik's business would suffer, if Telik's competitors develop and market products that are more effective than its product ...Amicus Therapeutics Announces Second Quarter 2009 Financial Results
... the potential that it may be difficult to enroll patients in our clinical trials; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; and, our dependence on third parties in the conduct of our clinical studies. ...Sunesis Reports Financial Results for the Second Quarter 2009
... risks related to Sunesis' need for additional funding, the risk that Sunesis' drug development activities could be halted significantly or delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the ...New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
... clinical endpoints; label expansion requests or NDA filings not being submitted and/or accepted in a timely manner; regulatory approval being delayed or not received; or manufacturing and supply issues. The potential for BYETTA and/or exenatide once weekly may also be affected by government and ...Wyeth Sets Webcast and Conference Call For 2009 Second Quarter Earnings
... call with research analysts at 8:00 a.m. Eastern Time on July 23, 2009. Interested investors and others may listen to the call live or on a delayed basis through our Internet webcast, which may be accessed by visiting our website at www.wyeth.com and clicking on the "Investor Relations" icon. ...Microbix Sales Grow Over 30% In The Second Quarter; Up 43% In The First Half '09
... for Urokinase manufacturing, and the corresponding sales and marketing infrastructure. The anticipated launch of the drug Kinlytic has been delayed due to the ongoing review by the FDA of the Company's request for the release of this Urokinase product for distribution in the US market. The ...Nektar Therapeutics Reports First Quarter 2009 Financial Results
... and efficacy findings; (ii) the timing or success of the commencement or end of clinical trials and commercial launch of partnered products may be delayed or unsuccessful due to slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical trial design, ...Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
... filings, including the NDA filing mentioned in this press release, not being submitted and/or accepted in a timely manner; regulatory approval being delayed or not received; or manufacturing and supply issues. The potential for BYETTA and/or exenatide once weekly may also be affected by government and ...China Sky One Medical, Inc. Provides Update on Filing Form 10-K
... whether these escrow shares will lead the company to record a non-cash compensation expense during 2008. This is the only outstanding issue that has delayed the filing of its annual report on form 10-K. On a pro forma basis that excludes the impact of any potential non-cash, non-operational expense ...Amylin Pharmaceuticals Provides Shareholders with Update Regarding Recent Developments
... Application ("NDA") filings, including the NDA filing for exenatide once weekly, not being submitted in a timely manner; regulatory approval being delayed or not received; or manufacturing and supply issues. The potential for BYETTA, SYMLIN and/or exenatide once weekly may also be affected by government ...Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2008 Financial Results
... funding; the risk that Sunesis' development activities for voreloxin, including enrollment and reporting of results, could be halted significantly or delayed for various reasons; the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval; the ...