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Regulatory in Biological Technology

KV Pharmaceutical Announces Stockholder Action to Amend By-Laws is Invalid

... product development, product launches, regulatory approvals, market position, acquisitions, sale of ... arrangements with third parties; (10) the regulatory environment, including regulatory agency and judicial actions and changes in ...

NeurogesX Reports Second Quarter 2009 Results

... requests and successfully navigating the European regulatory processes to gain marketing approval in the ... in order to focus on activities related to regulatory reviews in the United States and European Union. ... our cash resources towards achieving U.S. regulatory approval of Qutenza and conducting ...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... development timelines and the likelihood of regulatory success. All forward-looking statements and other ... trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon this data, in combination ...

Curis and Debiopharm Sign an Exclusive License Agreement Covering the HSP90 Inhibitor CUDC-305

... achievement of specified clinical development and regulatory approval objectives as well as royalties ... drug delivery and formulation, and regulatory affairs. Founded in 1979 and headquartered ... delays in obtaining or maintaining required regulatory approvals for products under development ...

Angiotech Pharmaceuticals, Inc. announces financial results for the second quarter ended June 30, 2009

... expenses and other current assets. New TAXUS regulatory Approvals and Clinical Data. In July 2009, we ... 30, 2009 and 2008 will be filed with the relevant regulatory agencies, as well as posted on our website at ... and the timing of decisions, made by health regulatory agencies regarding approval of our technology and ...

NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application

... but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that ... analysis or information by the FDA in support of regulatory approval; plans and timing for commercialization ... prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to ...

Amicus Therapeutics Announces Second Quarter 2009 Financial Results

... leveraging Shire's significant ex-U.S. regulatory and clinical experience as well as its commercial ... timing and outcomes of ongoing discussions with regulatory authorities and the potential goals, progress, ... potential inability to reach final agreement with regulatory agencies on the lifting of the clinical hold on ...

Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results

... thus far during the year as it completes the regulatory requirements for this program. As of June ... and assuming a total of $15.0 million in regulatory milestone payments as required under the ... timeframe in which Cadence anticipates receiving regulatory approval for Acetavance, and the company's ...

Optimer Pharmaceuticals Reports Second Quarter 2009 Financial Results

... scale-up expenses and expenses to prepare regulatory filings related to the Company's fidaxomicin and ... second fidaxomicin Phase 3 trial and preparing regulatory filings for fidaxomicin and prulifloxacin." ... and anticipated results, and plans related to regulatory filings and presentations of clinical trial ...

SENOMYX ANNOUNCES CORPORATE UPDATE AND SECOND QUARTER 2009 FINANCIAL RESULTS

... pursuing final development activities to support regulatory filings for S6973 in the U.S. and elsewhere. ... granted a GRAS (Generally Recognized As Safe) regulatory designation that allows commercialization in the ... on-track with development activities to support regulatory filings for S6973, a sucrose enhancer that ...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

... take advantage of a wide range of financial and regulatory benefits, including government grants for ... and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not ... money to complete and positive results leading to regulatory approval cannot be assumed; DOR is dependent on ...

NovaBay(R) Pharmaceuticals Names Roy J. Wu as Senior Vice President for Business Development

... clinical development, and Pacific sector regulatory and pharmaceutical development. "The ... project management. He has extensive regulatory experience with the U.S. Food and Drug ... for Human Use (ICH), which brings together the regulatory authorities of Europe, Japan and the United ...

NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results

... but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that ... prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to ... delays in, clinical development of, and obtaining regulatory approval for NeurogesX' product candidates. For ...

Cornerstone Therapeutics Announces Closing of Chiesi Transaction

... has a late-stage clinical pipeline with a recent regulatory submission filing and four additional regulatory approval submissions targeted within the next ... marketed products; our ability to maintain regulatory approvals to market and sell our products that do ...

Endo Pharmaceuticals Reports Strong Second Quarter 2009 Financial Results

... We continue to work closely with the FDA as their regulatory review moves forward." 2009 ... expense associated with, research, development, regulatory approval and commercialization of our products ... for certain core aspects of our business; new regulatory action or lawsuits relating to our use of ...

Amgen to Collaborate With GlaxoSmithKline to Commercialize Denosumab in Europe for Postmenopausal Osteoporosis (PMO)

... domestically and internationally, clinical and regulatory developments (domestic or foreign) involving ... regulation by domestic and foreign government regulatory authorities. Amgen or others could identify ... U.S. Food and Drug Administration (FDA) or other regulatory bodies, and no conclusions can or should be drawn ...

Peregrine Pharmaceuticals Licenses Anti-VEGF Antibodies to Affitech

... and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental ...

Schering-Plough Reports Financial Results for 2009 Second Quarter

... to advance. We continue to achieve positive regulatory actions in major markets - for example, the ... R&D engine has produced a number of recent regulatory and pipeline advances, including: ... of 2007; Positive opinion from the EU's regulatory authority in June recommending approval of ...

Idenix Pharmaceuticals Reports Second Quarter and Six Month 2009 Financial Results

... and is preparing documentation to support initial regulatory filings. The company has synthesized the first ... toxicology studies in two species to support regulatory applications. Finally, during the quarter, ... of its potential pipeline to the clinic, to the regulatory process or to commercialization. In particular, ...

Dow AgroSciences, Monsanto Complete U.S. and Canadian Regulatory Authorizations for SmartStax Corn; Plans Set to Launch Seed Platform on 3 Million- to 4 Million-Plus Acres

... U.S. Environmental Protection Agency (EPA) and regulatory authorization from the Canadian Food Inspection ... and Monsanto are also working with the regulatory agencies in key countries to have import ... in place prior to the 2010 U.S. season. These regulatory submissions are on track to support ...

Wyeth Announces Stockholder Approval of Pfizer Merger at 2009 Annual Meeting

... transaction remains subject to necessary global regulatory approvals and other customary closing conditions. ... expense associated with, research, development, regulatory approval and commercialization of our products ... of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our ...

PharmAthene's 2nd Generation rPA Anthrax Vaccine, SparVax(TM), Completes FDA Regulatory Strategy Review

... submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine. PharmAthene has ... even with the feedback on the Company's regulatory strategy from FDA, there can be no assurance that ... be shown to be safe and effective and approved by regulatory authorities for use in humans. Copies of ...

Cornerstone Therapeutics Inc. Announces Record Date and Meeting Date for Special Meeting of Stockholders for Vote with Respect to Charter Amendments

... also has a late-stage clinical pipeline with five regulatory approval submissions targeted within the next ... also has a late-stage clinical pipeline with five regulatory approval submissions targeted within the next ... therapeutic products; our ability to maintain regulatory approvals to market and sell our products that do ...

New Drug Application for Exenatide Once Weekly Accepted for Review by FDA

... once weekly is not currently approved by any regulatory agencies. Amylin Pharmaceuticals is a ... submitted and/or accepted in a timely manner; regulatory approval being delayed or not received; or ... the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the ...

Peregrine Awarded European Patent for Innovative Labeling Technology Featured in New Study in The Journal of Nuclear Medicine

... and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental ...

ADVENTRX Pharmaceuticals Announces Plans for Remainder of 2009

... ANX-530, including in humans; the potential for regulatory authorities to require additional preclinical work and/or clinical activities to support regulatory filings, including prior to the submission or the ... or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530, including ...

NeurogesX Added to Russell 3000 Index

... but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that ... prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to ... delays in, clinical development of, and obtaining regulatory approval for NeurogesX' product candidates. For ...

Horizon Therapeutics Names Dr. Jeffrey W. Sherman Executive Vice President and Chief Medical Officer

... experience to Horizon and will lead the regulatory and clinical strategy for Horizon's ... record of success in bringing drugs through the regulatory process," said Timothy P. Walbert, president and ... the preparation and submission of the HZT-501 regulatory applications to U.S. and ...

Mylan Announces Strategic Collaboration with Biocon to Enter the Global Generic Biologics Market

... development track record; appreciation of complex regulatory requirements; and state-of-the-art, ... one-of-a-kind global commercial footprint and our regulatory expertise around the world. Biocon also has a ... to: the content and timing of decisions by regulatory authorities related to the development and ...

OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer

... addresses the objectives necessary to support a regulatory submission. "We are now ready to proceed with ... design and size of a clinical trial to support a regulatory submission. This agreement can be in writing and ... clinical benefit and the potential for regulatory approvals. All statements other than statements ...

MasterControl and Datafarm Launch GxP2eCTD at the DIA 45th Annual Meeting

... leading provider of high performance electronic regulatory submission solutions for the life sciences ... leading provider of high performance electronic regulatory submission solutions for the life sciences ... is a world leader in high performance electronic regulatory submission solutions for the life sciences ...

B. Braun Medical Inc. Recognized by Industry for Manufacturing Influential Medical Devices

... the advent of precision technologies, landmark regulatory decisions and advances in device design from 1979 ... design, manufacturing, quality assurance, regulatory affairs and corporate management, each issue ... and production, materials, quality control, regulatory affairs, research and development, software, ...

Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study

... that these significant findings complete the regulatory package for Restanza in the post-exposure ... study report and submitting our data package for regulatory review based on our NDA for Restanza, which is ... market acceptance, government regulation and regulatory approval processes, intellectual property rights ...

Virtify, Inc. Delivers Industry's First Enterprise Content Compliance Software Suite for Life Sciences Companies

... to comply with different global standards and regulatory mandates such as Clinical Trial Disclosure, ... future mandates and initiatives by global regulatory bodies. "The cost of bringing new drugs to ... from the content requirements associated with regulatory compliance," said Alan Louie, Ph.D., research ...

Helix BioPharma to Present L-DOS47 Analytical Method Development Findings at 2009 AAPS National Biotechnology Conference

... non-clinical testing, clinical testing and regulatory treatment of established and emerging drug ... or manufacturing process, requirements of regulatory authorities, or other factors; the need to ... expected by the Company or at all; the need for regulatory approvals, which may not be obtained in a timely ...

Covance to Present at the Drug Information Association's 45th Annual Meeting

... Bruce Wagman, MBA, RN, RAC, vice president, regulatory affairs and quality assurance, clinical ... Baldrick, PhD, head of department, pharmaceutical regulatory affairs "Defining Quality in ... Session Chair: John Poland, PhD, senior director, regulatory policy, UK, clinical development services ...

Wyeth Announces Holder Right to Surrender Convertible Debentures

... expense associated with, research, development, regulatory approval and commercialization of our products ... of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our ... buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated ...

Data Presented at Society of Nuclear Medicine 2009 Annual Meeting Supports Potential of Peregrine's Cotara(R) for the Treatment of Brain Cancer

... said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "In this trial and in our ... and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in ...

Helix BioPharma Announces Q3 2009 Financial Results and Provides Product Development Update

... ("LSIL") During the quarter, Helix received regulatory approval to conduct its European Phase II ... will be filed today with Canadian securities regulatory authorities and will be available on SEDAR at ... of technical obsolescence; the need for further regulatory approvals, which may not be obtained in a timely ...

ERT to Showcase Its Clinical Trials Portfolio at DIA's 45th Annual Meeting at Booth #507

... HTS Inc and will discuss FDA safety concerns and regulatory requirements regarding suicidality assessments ... sessions including key speakers from key regulatory agencies, e.g. FDA and EMEA. ERT is a ... accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration ...
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