Regulatory in Medical News

Warner Chilcott Reports Operating Results for the Quarter Ended June 30, 2009 and Updates 2009 Full Year Guidance

... facility to produce our products or production or regulatory problems with either third party manufacturers ... with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of ... such new products; our ability to obtain regulatory approval and customer acceptance of new products, ...

Labopharm Reports Results for Second Quarter Fiscal 2009

... on Friday, July 24, 2009. Submitted regulatory Application in Canada - Labopharm filed a new ... treatment of major depressive disorder, is under regulatory review in the U.S. by the FDA. The Company also ... including the uncertainties related to the regulatory process in various countries for the approval of ...

Blue Cross Blue Shield of Michigan, Michigan Attorney General and Michigan Office of Financial and Insurance Regulation Near Agreement on Rate Increases on Under Age 65 Individual Products

... of people seeking their own coverage and a broken regulatory system that requires BCBSM to cover all ... conditions. Another problem with the regulatory system is the amount of time it takes for rates ... health care companies operating in the broken regulatory system. BCBSM insures older, less healthy ...

Orexigen(R) Therapeutics Announces Second Quarter 2009 Financial Results

... conferences, peer-reviewed journals and regulatory agencies. These results build ... Michael Scaife, Ph.D. as Senior Vice President of regulatory Affairs and Product Development, Contrave ... served as Senior Vice President of Global Safety, regulatory Affairs and Quality for Chiron Biopharma, and in ...

Bipartisan Panel of Industry, NGO and Academic Experts Proposes New Rules for Science in Federal Regulation

... -- A bipartisan panel of top scientific and regulatory experts today released recommendations calling on ... federal agencies to make specific changes in the regulatory process to clearly distinguish scientific ... "Our recommendations would make the regulatory process more rigorous and transparent," said ...

Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers

... all data sources available to them, and work with regulatory agencies to update the label as appropriate based ... metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and ... for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past ...

Cardiome Announces Management Transition

... the completion of clinical trials and obtaining regulatory approval to market our products, the ability to ... not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant ... at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com . Given these risks ...

ATS Medical Announces Second Quarter 2009 Results

... quarter of 2008. The Company received regulatory approval of the Simulus semi-rigid band in the ... the results of clinical trials, the timing of regulatory approvals, the integration of 3f Therapeutics and ... business of CryoCath Technologies, Inc., regulatory actions, competition, pricing pressures, supplier ...

DURECT Corporation Announces Second Quarter 2009 Financial

... for this program that laid out a potential regulatory pathway for the Phase III program and approval. ... concerns, the potential that FDA may not grant regulatory approval of REMOXY, failure of our clinical ... additional work or other requirements imposed by regulatory agencies for continued development, approval or ...

Warner Chilcott Announces Receipt of Paragraph IV Certification Notices

... facility to produce our products or production or regulatory problems with either third party manufacturers ... with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of ... such new products; our ability to obtain regulatory approval and customer acceptance of new products, ...

STAAR Surgical Generates Cash From Operations During Second Quarter

... IOL sales increased 8% sequentially. Recent regulatory approvals provide additional revenue ... In addition, we are making progress in the regulatory process towards the approval of the Visian ICL ... of the Center of Excellence project and reduced regulatory consulting fees, although the investment level is ...

BioMarin Announces Second Quarter 2009 Financial Results

... studies for each of these are planned for 2010. regulatory approval and commercial availability of the ... Kuvan, and its product candidates; and actions by regulatory authorities. These forward-looking statements are ... Administration, the European Commission and other regulatory authorities concerning each of the described ...

Cepheid Reports 2009 Second Quarter Results

... to potential growth in clinical product sales, regulatory developments, product pipeline, demand for ... new products; uncertainties related to the FDA regulatory and European regulatory processes; the level of testing at clinical ...

CryoLife Reports Record Quarterly Revenues of $28.2 Million

... and product liability claims and additional regulatory scrutiny as a result, the possibility that the ... inability to use them fully or at all, adverse regulatory action outside of the U.S. could affect our ... in obtaining necessary clinical results and regulatory approvals for products and services in ...

CSC's FirstDoc Recognized by EMC as a Preferred Regulatory Compliance Application for Life Sciences Industry

... EMC will now offer CSC's FirstDoc as a preferred regulatory compliance application. FirstDoc, based on the ... that EMC recognizes FirstDoc as a preferred regulatory compliance application for the life sciences ... challenge and expense of meeting increased regulatory scrutiny and quality procedures. Specifically, it ...

STERIS Corporation Announces Fiscal 2010 First Quarter Results

... factors, technology advances, actions of regulatory agencies, and changes in government regulations ... be provided as to any outcome from litigation, regulatory action, administrative proceedings, government ... compliance with laws, court rulings, regulations, regulatory actions, including without limitation previously ...

BioCryst Reports Second Quarter 2009 Financial Results And Provides Corporate Update

... development of peramivir through the traditional regulatory pathway. The successful Phase 3 studies ... in excess of the amount necessary to support U.S. regulatory approval. HHS is reviewing the purchase in light ... Phase 3 studies intended to support U.S. regulatory approval for uncomplicated influenza and ...

ViroPharma Incorporated Reports Second Quarter 2009 Financial Results

... and potential outcomes of the review of our regulatory submission related to an acute treatment ... Cinryze; our ability to receive regulatory approval for the use of Cinryze for additional ... with Vancocin and Cinryze; the timing of regulatory submissions and approvals; actions by the ...

WellPoint Reports Second Quarter 2009 Results

... capital levels $5.6 billion higher than state regulatory requirements, and $2.4 billion higher than Blue ... by approximately $2.4 billion and state regulatory levels by approximately $5.6 billion. Cash and ... Scripts transaction; the failure to receive regulatory approvals required for the Express Scripts ...

Cardiome Achieves Milestone From Collaboration With Merck Co., Inc.

... the completion of clinical trials and obtaining regulatory approval to market our products, the ability to ... not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant ... at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com . Given these risks ...

Immucor Announces Fiscal Fourth Quarter Results

... for the molecular immunohematology products; regulatory obstacles including obstacles in securing regulatory approval of the BioArray technology; the ... income levels; the outcome of any legal claims or regulatory investigations known or unknown, including the ...

Bioheart Announces Acceptance of Marvel-1 Data for Presentation at the Heart Failure Society of America (HFSA) Meeting

... Owens, RN, MPH, CCRA, Director of Clinical and regulatory Affairs, at Bioheart, Inc., states "We are very ... on the discovery, development and, subject to regulatory approval, commercialization of autologous cell ... of and our ability to obtain and maintain regulatory approvals for our product candidates; (vii) our ...

Wyeth Reports Earnings Results for the 2009 Second Quarter and First Half and Raises Full Year 2009 Guidance

... related conference call regarding development and regulatory timelines for our pipeline products are subject ... related to both the timing and success of regulatory submissions and review and decisions by regulatory authorities, including the possibility ...

Human Genome Sciences Announces Second-Quarter 2009 Financial Results and Key Developments

... pre-submission meetings with the FDA and European regulatory agencies, and are on track for submission of ... No new drug for lupus has been approved by regulatory authorities in more than 50 years. BENLYSTA is ... the United States; Pre-Submission Meetings with regulatory Authorities Completed - on Track for Fall ...

Lilly Reports Solid Second-Quarter 2009 Results, Raises EPS Guidance

... development. We also received several important regulatory approvals, most notably Effient in the U.S. Based ... chemotherapy. Alimta received regulatory approval in Japan as both a first- and ... receive the necessary clinical and manufacturing regulatory approvals or that they will prove to be ...

-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-

... conferences, peer-reviewed journals and regulatory agencies. "The successful ... Phase 3 clinical trials and is on track for a regulatory submission with the FDA in the first half of ... of Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, ...

NeurogesX Announces Resignation of Bruce A. Peacock from Board of Directors

... his contributions to NeurogesX during the initial regulatory approval and E.U. partnership discussions ... and Audit Committee; 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 ...

VIVIMIND(TM) granted certificate of free sale as food supplement in Italy - Premarket notification filed in the U.S.

... a beneficial effect on cognition(1). U.S. regulatory Update With respect to the United States, ... and is pursuing mandatory associated regulatory activities to obtain marketing approval for ... and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the ...

Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product

... markets, today announced that it has submitted a regulatory filing with the U.S. Food and Drug Administration ... dosing. "This is an important regulatory submission for Cornerstone, as it is the first of ... late-stage clinical pipeline with four additional regulatory approval submissions targeted within the next ...

Wyeth Announces Results of the Company's Offer Relating to 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 ...

Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009

... of TRILIPIX(R) and CRESTOR(R), for U.S. regulatory approval and received CE Mark for XIENCE ... from SPIRIT PRIME will be used to support the regulatory filing for XIENCE PRIME in the United States. ... second quarter, we submitted CERTRIAD for U.S. regulatory approval. CERTRIAD is the fixed-dose combination ...

Wyeth's Prevenar 13* Receives First Approval

... of Prevenar 13 in Chile is the first of many regulatory decisions we anticipate receiving around the ... filings in late 2008 and, to date, has submitted regulatory applications for Prevenar 13 in more than 50 ... in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010. ...

Peregrine Pharmaceuticals Reports Financial Results for Fiscal Year 2009

... 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 ...

Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published

... 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 ...

New role discovered for molecule important in development of the pancreas

... to play an additional and previously unknown regulatory role in the development of cells in the immature ... also indirectly regulates it by controlling the regulatory network of Sox9, Foxa2, Hnf6, and Hnf1b," she ... Now, says Stoffers, the question is: Does this regulatory pathway look and act the same in humans as in ...

DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing

... establishment registration and product listing regulatory content, SPL technical content, or the ESG ... Therese Brunone, MS, Assistant Director, Global regulatory Operations, GlaxoSmithKline. About the Drug ... involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and ...

New Drug Fights Anthrax Toxin

... Bolmer, senior vice president of development and regulatory affairs at Human Genome Sciences Inc., the ... satisfies the criteria of the animal rule, a regulatory guideline used to approve drugs for diseases that ... Ph.D., senior vice president, development and regulatory affairs, Human Genome Sciences Inc., Rockville, ...

BELLUS Health Inc. Announces $12 Million Rights Offering To Common Shareholders

... Due to applicable securities law and regulatory restrictions, only Eligible Shareholders will be ... shareholders. Due to such securities law and regulatory restrictions, the offering is not available to ... shares. The rights offering is subject to regulatory approval, including that of the Toronto Stock ...

REMOXY(R) NDA Update

... additional payments if certain development and regulatory milestones are achieved with respect to the ... concerns, the potential that FDA may not grant regulatory approval of REMOXY, difficulties or delays in the development, testing, regulatory approval, production and commercialization of ...

ADVENTRX Pharmaceuticals Announces Closing of Financing

... 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 ...