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Mayo Clinic Proceedings: A Comprehensive Review of Addiction to Prescription Painkillers Among Patients and Physicians

ROCHESTER, Minn., July 7 /PRNewswire-USNewswire/ -- Chemical dependency and recovery in patients and physicians are closely examined in a series of articles and editorials in the July 2009 issue of Mayo Clinic Proceedings . The subject is especially timely. As the immense challenges, inclu...

New Review on PROSTVAC(TM) Published by Key Investigators From NCI

KVISTGAARD, Denmark, July 1 /PRNewswire-FirstCall/ -- A just published Review in the publication "Expert Opinion on Investigational Drugs", Volume 18, Issue 7 2009, confirms the previous published information on PROSTVAC(TM). This is the most comprehensive and updated Review on PROSTVAC(TM) so...

China Animal Welfare Law Under Review While 36,000 Dogs Culled

BEIJING, June 16 /PRNewswire-USNewswire/ -- Today the Chinese state media announced that the dog cull in Hanzhong city, Shaanxi Province has reached a death toll of 36,000. Claiming rabies outbreak, the city has sent out dog-beating squads to kill any animal spotted on the street, stray or owned. ...

Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza(TM) (cethromycin)

CHICAGO, June 2 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) announced today that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient treatment of adults with m...

Alimera Sciences' Iluvien(TM) Phase 3 Studies for DME Pass Final DSMB Review Prior to October Readout

ATLANTA, April 8 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that an independent Data Safety Monitoring Board (DSMB) has recommended...

FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)

- PDUFA Date for Cinryze for Acute HAE Indication is June 3, 2009 - EXTON, Pa., Feb. 3 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM ) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Cinryze C1 Inhibitor (human) as a trea...

Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients

EAST BRUNSWICK, N.J., Jan. 28 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced that its biologics license application (BLA) for pegloticase for treatment-failure gout will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug A...

ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration

IRVINE, Calif., Jan. 15 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA ), today announced that ISTA's New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company is seek...

MannKind Corporation to Review Positive Results From Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes

Live Broadcast on December 18, 2008 at 9 a.m. Eastern Time VALENCIA, Calif., Dec. 15 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD ) will host a live broadcast to review clinical results from its final two Phase 3 studies of AFRESA(TM), the company's ultra rapid actin...

Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008

REINACH, Switzerland, October 14 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee will discuss the New Drug Application (NDA) for intravenous ...

RAD001 Granted Priority Review in the US Based on Potential to Fill Unmet Medical Need in Patients With Advanced Kidney Cancer

-- Regulatory applications to be submitted worldwide for RAD001 first submissions filed in the Hidden List US, EU and Switzerland -- Data showing that RAD001 more than doubles time without tumor growth and reduced risk of disease progression by 70% now published in The...

REMOXY(R) NDA Filing Accepted by FDA and Priority Review Granted

CUPERTINO, Calif., Aug. 12 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX ) announced today that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of REMOXY(R) and granted Priority Review. The FDA typically grants Priority Review to drug candida...

Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation

BRIDGEWATER, N.J., Aug. 8 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that U.S. Food and Drug Administration (FDA) has assigned priority review status for its New Drug Application (NDA) for Multaq(R) (dronedarone). The priority review period begins on...

Generex Biotechnology Corporation Initiation Coverage Review Issued By Scimitar Equity, LLC

BOSTON, July 30 /PRNewswire/ -- Scimitar Equity, LLC issues a review of Generex Biotechnology Corporation (Nasdaq: GNBT ), entitled, "RapidMist(TM), the Non-Invasive Oral Drug Delivery Platform, Sets the Tone as Best in Class Followed by an Expanding Pipeline and Global Revenues." This revi...

Advaxis, Inc Initiation Coverage Review Issued By Scimitar Equity, LLC

BOSTON, July 15 /PRNewswire/ --Scimitar Equity, LLC issues a review of Advaxis, Inc (OTC Bulletin Board: ADXS), entitled, "The New Generation of Cancer Immunotherapeutics". This review is available at website: http://www.scimitarequity.com . Based in North Brunswick, New Jersey, Advaxis, ...

FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel

Companies confirm the start of TRILOGY ACS clinical trial to study Prasugrel against Clopidogrel in medically managed ACS patients TOKYO and INDIANAPOLIS, June 23 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, (TSE:4568) and Eli Lilly and Company (NYSE: LLY ) said that the U...

GSK Update on FDA Review of Promacta(R) (Eltrombopag)

PHILADELPHIA, Pa. June 20 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK ) today announced that the United States Food and Drug Administration has extended the priority review period for PROMACTA(R) (eltrombopag) for the short-term treatment of previously treated patients with chronic i...

ASPIRE Independent Review Board Announces 10 Ways to Protect Participants' Rights in Clinical Drug Trials and Optimize Results From Research

ASPIRE IRB Is Exhibiting at Bio International Convention in San Diego June 17-20 Currently, over 54,255 Trials with Locations in 154 Countries Are Taking Place SAN DIEGO, June 9 /PRNewswire/ -- ASPIRE IRB ( http://www.aspire-irb....

CNS Response, Inc. Provides Review of Poster Session Delivered at the American Psychiatric Association 161st Annual Meeting

Preliminary Analysis of rEEG(R) Guided Medication Study Demonstrates an Improvement in Depression and Eating Disorder Symptoms COSTA MESA, Calif., May 22 /PRNewswire-FirstCall/ -- CNS Response, Inc. (OTC Bulletin Board: CNSO) reported today the results of a study presented at the Ameri...

Got Fat?: Plastic Surgeons Review Fat-Melting and Fat-Grafting Procedures

Emerging Trends Discussed at American Society for Aesthetic Plastic Surgery's Annual Meeting NEW YORK, May 2 /PRNewswire-USNewswire/ -- New techniques and devices for surgical and nonsurgical cosmetic enhancement are being introduced at a rapid pace, but do these innovations really deli...

FDA Grants Priority Review for PROMACTA(R) (eltrombopag)

PHILADELPHIA and LONDON, March 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK ; LSE) today announced that the United States Food and Drug Administration has granted Priority Review for PROMACTA(R) (eltrombopag) for the short-term treatment of patients with chronic idiopathic thrombocy...

FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents

WOODCLIFF LAKE, N.J., Feb. 29 /PRNewswire/ -- Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has accepted an ACIPHEX supplemental New Drug Application (sNDA) for the short-term (up to eig...

FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel

Investigational antiplatelet agent submitted for treatment of patients with acute coronary syndrome being managed with percutaneous coronary intervention TOKYO and INDIANAPOLIS, Feb. 21 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited (TSE: 4568) and Eli ...

Micromet Announces the Publication of BiTE Antibody Review in Drugs of the Future

BETHESDA, Md., Feb. 12 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI ), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced the publication of a comprehensive review article entitled, ...

FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J., Jan. 14 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA ) announced today that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasens...

Berkery Noyes Represented The Thomson Corporation in the Sale of CenterWatch and New England Institutional Review Board to Jobson Medical Information

NEW YORK, Jan. 4 /PRNewswire/ -- Berkery Noyes announced today that the firm represented The Thomson Corporation (NYSE: TOC ; TSX: TOC) in the sale of CenterWatch ("CW") and New England Institutional Review Board ("NEIRB") to Jobson Medical Information, a portfolio company of The Wicks Group,...

FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma

BERKELEY HEIGHTS, N.J., Dec. 21 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA ) announced today that the Company has received notice from the Food and Drug Administration (FDA) that FDA has extended its review period of Genta's request for correction of certain information that w...

Initiation of Coverage Informational Review Issued by Scimitar Equity Research

BOSTON, Dec. 17 /PRNewswire/ -- Scimitar Equity Research, Inc. issues a review on Nventa Biopharmaceuticals Corporation (TSX: NVN) entitled: "A Very Promising Therapeutic and Vaccine Candidate for the Treatment of Diseases Caused by the Human Papillomavirus (HPV)." The analyst research is avai...

Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data

No Safety Concerns Raised Sulodexide Phase 3 study to continue without modification NEW YORK, Dec. 5 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals (Nasdaq: KERX ) today announced that the Independent Data Safety Monitoring Committee (DSMC) responsible for mon...

Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve

REDWOOD CITY, Calif., Oct. 30 /PRNewswire/ -- Emphasys Medical, Inc. today announced that its pre-market approval (PMA) application for the Zephyr(R) Endobronchial Valve (EBV) has been accepted as suitable for filing by the U.S. Food and Drug Administration (FDA) and has been granted expedited...

Risks Associated With Face Transplants May Be Lower Than Previously Thought, ASPS Journal Review Suggests

ARLINGTON HEIGHTS, Ill., Oct. 10 /PRNewswire-USNewswire/ -- Face transplants, once on the fringe of medicine, may eventually become more mainstream because of new estimates that suggest the risk of tissue rejection might be lower than previously thought, according to a recent review in Plastic...

Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis

SEATTLE, Sept. 17 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation (Nasdaq: TGEN ) today reported on the public hearing conducted by the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), which reviewed the serious adverse event reported by Targeted Genetics ...

GlaxoSmithKline Accelerates Review of Exelixis' XL880

- Early review expected to facilitate rapid advancement of leading MET inhibitor into later stage clinical studies - SOUTH SAN FRANCISCO, Calif., Aug. 23 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL ) today announced that it has agreed to a request from GlaxoSmithKline ...

Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline

Research by CMR Shows Revenue Derived from New Products Launched within the Last Five Years has Dropped to Just 16% of Total Revenue in 2006 PHILADELPHIA, Aug. 15 /PRNewswire-FirstCall/ -- Thomson Scientific, part of The Thomson Corporation (NYSE: TOC ; TSX: TOC) and leading provider of info...

Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review

EXTON, Pa., May 8 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (NYSE Amex: ILE ) today announced that the United States Food and Drug Administration ("FDA") has completed its initial review of the Company's Biologics License Application ("BLA") related to its Nasolabial Fold/Wrinkles product can...

European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review

SEATTLE, April 2, 2008 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC ; MTA) today announced that the European Medicines Agency (EMEA) has accepted for review CTI's Marketing Authorization Application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line ...

Independent Data Safety Monitoring Board Recommends Continuation of Sangart's Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review

SAN DIEGO, March 11 /PRNewswire/ -- Sangart, Inc., a privately held biopharmaceutical company focused on the research, development and commercialization of oxygen transport agents, today announced that an independent data safety monitoring board (DSMB) has recommended the continuation of both ...

Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review

- Review Based on MOSAIC Clinical Trial Demonstrating Significantly Improved Six-year Overall Survival in Stage III Colon Cancer Following Surgery Compared to Standard Regimen Alone - BRIDGEWATER, N.J., Feb. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis today announced that the...

ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review

NEW YORK, Aug. 7 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY ) today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the supplemental biologics license application (sBLA) for ORENCIA(R) (abatacept) for the treatment of pedi...

Inflazyme Announces Outcome of Review of Phase 2b Asthma Study: Potential Mitigating Factors Identified which Prevent Clear Interpretation of Results

RICHMOND, British Columbia, March 12, 2007--Inflazyme Pharmaceuticals Ltd. (TSX: IZP). As announced on January 29, 2007, the preliminary results of the Phase 2b CAPSICS study with IPL512,602 showed no statistical or clinical difference between patients who received drug or placebo. However, the pl...
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