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Response in Medical Technology

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

PHILADELPHIA, July 28 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV(TM) (guanfacine) Extended Release from the Food and Drug Administration (FDA). Thi...

Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

PALATINE, Ill. and BRISTOL, Tenn., July 2 /PRNewswire-FirstCall/ -- Acura Pharmaceuticals, Inc. (Nasdaq: ACUR ) and King Pharmaceuticals, Inc. (NYSE: KG ) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (...

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes

DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response ...

MJFF's Rapid Response Innovation Awards Hit Mid-2009 With Over $1 Million Funded in High-Risk/High-Reward Approaches to Parkinson's Disease

NEW YORK, June 25 /PRNewswire-USNewswire/ -- As of mid-2009, The Michael J. Fox Foundation for Parkinson's Research has already funded over $1 million in high-risk, high-reward approaches to Parkinson's therapeutic development through its groundbreaking Rapid Response Innovation Awards . Projects...

Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th

SEATTLE, June 22 /PRNewswire-FirstCall/ -- Updated follow-up phase III EXTEND (PIX 301) clinical trial data enhances previously reported superior response rates for pixantrone over comparator including in high risk patient subgroups Additional Clinical Studies Also Highlighted at Pan ...

Micromet Presents Update on Blinatumomab's Response Rate and Duration in a Phase 1 Study in Non-Hodgkin's Lymphoma Patients

Data Presented at Meeting of European Hematology Association Confirms High Response Rate and Durability of Remissions BERLIN, June 8 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI ), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, in...

Pixantrone in Combination with Chemotherapy Regimens Produces Overall Response Rates of 58-74% with Complete Remission Rates of 37-57% in Relapsed/Refractory Aggressive or Indolent NHL

Overview of 11 peer review publications presented in 'Future Oncology' SEATTLE, June 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reports a summary of peer reviewed publications spanning preclinical, Phase I and Phase II clinical studies wit...

PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)

ANNAPOLIS, Md., June 2 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE Amex: PIP ), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that it has submitted a proposal to the Biomedical Advanced Research and Development Authority (B...

New Study Shows Probiotic Strain Effective in Boosting Immune Response to Flu Virus

Bacillus coagulans boosts a key immune marker in healthy people CLEVELAND, May 5 /PRNewswire/ -- A new study in the current issue of Postgraduate Medicine suggests that a specific strain of probiotics , Bacillus coagulans GBI-30, PTA-6086, increases the body's immune response to the flu ...

New Analysis Evaluated Impact of Genetic Variation on Response to Prasugrel

TOKYO and INDIANAPOLIS, Ind., May 5 /PRNewswire-FirstCall/ -- A new substudy from 1,466 patients from the Phase III TRITON-TIMI 38 clinical trial showed that patients who took prasugrel and had a reduced function of the CYP2C19 gene did not have an increased risk of cardiovascular death, heart att...

One Call Now Offers Notification Service at NO CHARGE for Governments, Schools, Businesses, Religious Organizations and Others in Response to Swine Flu Outbreak

TROY, Ohio, April 28 /PRNewswire/ -- In response to outbreaks of swine flu across North America, One Call Now, America's leading emergency notification service, has issued professionally-written influenza notification scripts for use by its 35,000 clients to inform and protect the millions of fami...

CareHere's Electronic Medication System Proves 100 Percent Effective in Response to Recall

NASHVILLE, Tenn., April 16 /PRNewswire/ -- When the U.S. Food and Drug Administration (FDA) issued a recall of a widely used heart medication last month, CareHere's proprietary medication tracking system allowed the company to instantly generate a list of all patients taking the medication. For...

Nation's Laboratory Response Network Marks First Decade of Protecting Public Health

SILVER SPRING, Md., March 30 /PRNewswire-USNewswire/ -- The Laboratory Response Network (LRN), the national laboratory system charged with protecting the public in health emergencies, will mark its first decade at its national meeting in Orlando, Florida, April 1-3, 2009. Founded in 1999 by t...

FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)

CHADDS FORD, Pa., March 12 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP ) and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV ) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the complete response submission to...

St. Jude Finds More Than 100 Gene Variations Linked With Response to Leukemia Treatment

Scan of thousands of inherited genetic changes reveal specific variations linked to treatment failure and the fate of chemotherapy drugs in the body for children with acute lymphoblastic leukemia MEMPHIS, Tenn., Jan. 27 /PRNewswire-USNewswire/ -- Scientists from St. Jude Children's Research H...

U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

Schering-Plough expects to respond to agency during first quarter KENILWORTH, N.J., Jan. 14 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS(TM) (asenapine) s...

FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults

INDIANAPOLIS, Jan. 7 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) announced today that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in ad...

Agendia's MammaPrint(R) Predicts Response to Neoadjuvant Chemotherapy in Breast Cancer

HUNTINGTON BEACH, California and AMSTERDAM, December 12 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced MammaPrint(R)'s ability to predict response to neoadjuvant chemotherapy in breast cancer. Dr. Laura van 't Veer, from the Netherlands Cancer Inst...

Three Studies Presented at the American Society of Hematology Annual Meeting Showed Response to Treatment with Campath(R) in Patients with High-Risk CLL

Data Showed Campath May Lead to Overall Survival in Patients with Poor Prognostic Factors SAN FRANCISCO, Dec. 9 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced results from three studies showing that treatment with Campath(R) (alemtuzumab) showed activity in high-ris...

Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia

Tasigna now shows potential to become the treatment of choice for certain newly diagnosed patients with chronic myeloid leukemia Two separate studies show rapid elimination of cancer cells in 96% of Tasigna patients and reduction of abnormal CML protein by six months ...

Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)

Data from a pivotal trial suggests that ofatumumab has activity in heavily pre-treated patients who have failed standard treatments PHILADELPHIA, Dec. 8 /PRNewswire-USNewswire/ -- GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today positive results from a pivotal trial pr...

Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients

Interim results of HCV SPRINT-1 study presented at AASLD annual meeting Pivotal Phase III studies ongoing in treatment naive patients and those who failed prior treatment SAN FRANCISCO, Nov. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported that a planned...

New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients

- Higher Sustained Virological Response Rates Recognized as Marker of Treatment Success - SAN FRANCISCO, Calif., Nov. 1 /PRNewswire/ -- A new, independently-conducted study being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) shows th...

Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen

ABBOTT PARK, Ill., Oct. 20 /PRNewswire-FirstCall/ -- Abbott has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for a controlled-release form of hydrocodone with acetaminophen. Abbott is evaluating the FDA Complete Respons...

Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain

FDA Requests Enhancements to Risk Mitigation Strategies Consistent with Company's Recommendations FRAZER, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today receipt of a complete response letter from the Food and Drug Administration (FDA...

Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients

74 percent of patients achieved SVR 12 with 48-week boceprevir-based combination therapy High SVR 24 rate also reported for 28-week boceprevir arm KENILWORTH, N.J., Aug. 4 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported top-li...

Michael J. Fox Foundation Funds $1.1 Million for Cutting-Edge Approaches to Parkinson's Disease Under Rapid Response Innovation Awards 2008

$2 million in total funding expected by year's end NEW YORK, July 29 /PRNewswire-USNewswire/ -- Gene silencing techniques and induced pluripotent stem cell technology are among the cutting-edge approaches to Parkinson's drug development funded through The Michael J. Fox Foundation's Rapid Re...

ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor(R)

SAN DIEGO, July 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX ) today announced preliminary response rate results from its discontinued Phase 3 clinical trial of ANX-510, or CoFactor, the Company's folate-based biomodulator of 5-FU (5 fluorouracil), for the treatment o...

MAP Pharmaceuticals Reports Positive Pharmacological Response Data for Migraine Product Candidate at the American Headache Society Annual Meeting

MOUNTAIN VIEW, Calif., June 28 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) today presented data from an in-vitro study evaluating receptor pharmacology of MAP0004, orally inhaled dihydroergotamine (DHE) for the potential treatment of migraine, compared to intravenous (...

New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study

Results Presented at the ADA's Annual Scientific Sessions SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the results of the dose-finding study for its new injectable diabetes compound AVE0010, a GLP-1 agonist, were presented at the American Diabetes ...

Phase 1/2 Trial of Motexafin Gadolinium Plus Antibody Targeted Radiation Therapy Demonstrates High Complete Response Rate in Patients With Non-Hodgkin's Lymphoma

SUNNYVALE, Calif., June 5 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC ) today announced final data from a Phase 1/2 study showing a 46 percent complete response rate in patients with multiply recurrent non-Hodgkin's lymphoma (NHL) who were treated with motexafin gadolinium (MG...

VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma

-- IFM presents updated results from Phase III clinical trial -- CHICAGO, May 31 /PRNewswire/ -- Millennium Pharmaceuticals, The Takeda Oncology Company, today announced the presentation of updated results from a 482 patient, multi-center, randomized Phase III clinical trial, comparing VEL...

Genasense(R) Chemotherapy Program Yields High Response Rate in Patients with Stage 4 Melanoma

Related Clinical Study Shows Potential Utility of Short-Course High-Dose Therapy BERKELEY HEIGHTS, N.J., May 30 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced preliminary results that have shown a high objective response rate in...

Ipsogen Announces Three Studies at the American Society of Clinical Oncology (ASCO) Meeting Extending the Utility of the Genomic Grade Index for Predicting Response to Chemotherapy in Breast Cancer

MARSEILLE, France, May 19 /PRNewswire/ -- IPSOGEN SA (Marseille and New Haven), a cancer profiler that develops and markets molecular diagnostic assays for blood & breast cancers, announced today that researchers from the University of Texas MD Anderson Cancer Center (MDACC, Houston, TX) will ...

Amicus Therapeutics Presents Data from Clinical Ex Vivo Response Study and Phase 1 Studies of AT2220

Data Suggest Majority of Pompe Patients May Be Amenable to Chaperone Therapy CRANBURY, N.J., March 13 /PRNewswire/ -- Amicus Therapeutics, a biopharmaceutical company developing small-molecule, orally administered pharmacological chaperones for the treatment of...

Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release

INDIANAPOLIS, March 12 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ), strongly disagrees with the characterization of company practices as alleged by the Connecticut Attorney General Richard Blumenthal in a news release issued March 11, 2008. The tone and content of the relea...

Genetic Variation Associated with Treatment Response in a Clinical Study of a New Atypical Antipsychotic Fiaptatm (iloperidone)

ROCKVILLE, Md., Feb. 29 /PRNewswire-FirstCall/ -- A study reported in the journal Pharmacogenomics suggests that a genetic variation in the Ciliary Neurotrophic Factor gene (CNTF) may affect response to antipsychotic treatment. The study, conducted by Vanda Pharmaceuticals Inc., included patie...

Cell Genesys Reports Association Between Immune Response and Patient Survival in Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer

SOUTH SAN FRANCISCO, Calif., Feb. 15 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE ) today reports the results of an analysis examining the potential association between immune responses to GVAX immunotherapy for prostate cancer and increased patient survival in a Phase 2 trial i...

10 Million Square Feet of Turf Set to be Treated in 2008 in Response to MRSA Outbreaks Nationwide

ROCHESTER HILLS, Mich., Jan. 8 /PRNewswire/ -- CSG/SportsCoatings, today announced approximately 10 million square feet of synthetic turf will be treated with its industry-leading antimicrobial coating, TurfAide(TM), in 2008 -- up from 1.5 million square feet in 2007. The exponential increas...

Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C

- 85% of patients achieve undetectable HCV RNA levels following 4 weeks of treatment with R7128 1500mg and Pegasys(R) plus Copegus(R) with safety and tolerability comparable to placebo - - Conference Call Scheduled for 4:00PM ET Today - PRINCETON, N.J., Jan. 7 /PRNew...
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