meet in Medical Technology

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

INDIANAPOLIS and EDMONTON, Alberta, July 27 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

SOUTH SAN FRANCISCO, Calif., July 23 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL ) today announced that in the TASKi3 Phase 2b clinical trial in rheumatoid arthritis (RA) patients who had failed to respond to at least one biologic treatment, the group treat...

Accent on Aesthetics Plastic Surgery Medical Center Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

MOUNTAIN VIEW, Calif., July 21 /PRNewswire/ -- Howard Rosenberg, M.D., a board-certified plastic surgeon and Medical Director at Accent on Aesthetics Plastic Surgery Medical Center, has selected Artefill, the first and only FDA-approved microsphere-enhanced collagen filler for...

Phase 3 Trial of Nexavar in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint

WAYNE, N.J. and EMERYVILLE, Calif., April 27 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX ) today announced that a Phase 3 trial evaluating Nexavar(R) (sorafenib) tablets in patients with unresectable stage III or stage IV melanoma was s...

MAP Pharmaceuticals Announces Phase 3 Study of Unit Dose Budesonide in Children With Asthma Did Not Meet Primary Endpoints

MOUNTAIN VIEW, Calif., Feb. 23 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) announced today results of its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma. The Company announced that the clinical trial d...

AstraZeneca's Partner, MAP Pharmaceuticals, Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints

LONDON, Feb. 23 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. announced today that its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline i...

Isogen Retains Strategic Partner Sheridan Road Financial to Meet Global Biopharma Demand

NEWARK, Del., Dec. 3 /PRNewswire/ -- Isogen, a contract development and manufacturing organization for sterile filling, announced it has retained a strategic financial partner to help it expand operations to meet the global biopharma demand for Isogen's services. Isogen has previously anno...

Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints

SKOKIE, Ill., Dec. 2 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that two pivotal Phase 3 trials evaluating its lead investigational product candidate, HZT-501, met all primary endpoints. HZT-501, a novel, proprietary fixed-dose combinati...

Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant

Investor Conference Call to be held on Wednesday, August 6, 2008 at 8:00 a.m. EXTON, Pa., Aug. 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announced today positive top-line efficacy and safety results from two pivotal, Phase III clinical studies ...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

September meeting to focus on use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma SEATTLE, July 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced toda...

Nuvelo Announces Phase 2 SONOMA-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase Development

-Webcast to Be Held at 4:30 p.m. ET today- SAN CARLOS, Calif., March 17 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO ) today announced that data from the Phase 2 program in catheter occlusion (CO), known as SONOMA-3 (Speedy Opening of Non-functional and Occluded cathete...

Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint

Company to host a conference call Monday, March 10, 2008 at 8:30am NEW YORK, March 7 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) today announced top-line results from its SUN-MICRO Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of diabetic nep...

Clinical Studies of OvaRex in Advanced Ovarian Cancer Fail to Meet Primary Endpoint

Preliminary Analysis Demonstrates Studies Failed to Reach Statistical Significance SILVER SPRING, Md. and WELLESLEY HILLS, Mass., Dec. 5 /PRNewswire- FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR ) and its wholly- owned subsidiary, Unither Pharmaceu...

Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federal Mandates

Cleveland Clinic Researchers Highlight the Need For More Women to Participate in Clinical Trials ORLANDO, Fla., Nov. 6 /PRNewswire-USNewswire/ -- Cleveland Clinic researchers have recently found that women remain a significant minority in cardiovascular randomized contro...

Acuity One-Year Findings Meet All Primary Endpoints in Favor of Angiomax (Bivalirudin) Alone Treatment Group

Major Bleeding in Patients Treated for Acute Coronary Syndromes (ACS) Nearly Triples the Risk of Death at One Year NEW ORLEANS, March 26, 2007 /PRNewswire/ -- One-year findings from the landmark ACUITY trial show that acute coronary syndrome (ACS) patients in the "Angiomax(R) (bivalirudin) alone" ...

MIV Therapeutics Announces Pivotal Test Results Further Validating Company Stent Coatings Meet Critical FDA Fatigue Guidelines

ATLANTA--(BUSINESS WIRE)--Apr 5, 2007 - MIV Therapeutics Inc. (OTCBB:MIVT) (FWB:MIV), a leading developer of next-generation biocompatible coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, today announced that a recent Company sponsored ben...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

...Isis ended the quarter with $637.5 million of cash and remains on track to end 2009 with more than $550 million of cash. Isis also remains on track to meet its guidance of more than $145 million of pro forma net income and a pro forma net operating loss in the low to mid $20 million range, in both cases e...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

...y agencies to make velaglucerase alfa available as soon as possible to help meet the needs of the Gaucher community." Shire's velaglucerase alfa prog...e Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the ...

John Legend and Gap Join (PRODUCT)RED(TM) to Help Eliminate AIDS in Africa with Exclusive (RED)ZONE Seating at Madison Square Garden

...the show free of charge. Additionally, a select number of fans seated in the (RED)ZONE section will be randomly selected to go backstage to personally meet Legend after the evening's performance. Proceeds from the ticket sales in the (RED)ZONE will benefit HIV/AIDS programs in Africa supported by the Glob...

Online H1N1 Management: FairChoice Helps Schools Respond to Infectious Disease on Campus

...specifically designed for colleges and universities. The enhancement of FairChoice Health adds tracking and notification capabilities that will meet the challenges of H1N1 (Swine Flu). The new features adhere to CDC recommendations issued on May 1, 2009 for colleges and universities "to develop and...

Covance Receives Highest Level of Phase I Accreditation

...ncy (MHRA). This voluntary accreditation process provides clinical trial volunteers and sponsors with confidence that research facilities and studies meet the industry's highest safety standards. This accreditation was awarded to Covance's clinical research unit in Leeds, United Kingdom, where t...

European Division of Global Top 20 Pharmaceutical Company Awards Phase III Trial to DATATRAK

...ited operating history on which the Company's performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs; fluctuations in the Company's quarterly results; the viability of the Company's business strategy and its early stage of de...

Study Shows Cancer Vaccines Led to Long-Term Survival for Patients with Metastatic Melanoma and to Long Periods of Disease Control After Completion of Therapy

...13 consecutive years. For an unprecedented 13 years, residents have chosen Hoag as the county's best hospital in a local newspaper survey. In order to meet the growing needs of Irvine and South County residents, Hoag will open an Irvine campus in 2010. Hoag continues to offer additional services to the co...

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

...beling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. The FDA did not identify safety concerns regarding I...e Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the ...

Video: New Dove(R) Body Washes with NutriumMoisture(TM) Restore Skin's Natural Moisture

...aids. Dove is available nationwide in food, drug and mass outlet stores. About Unilever Unilever's mission is to add vitality to life. We meet everyday needs for nutrition, hygiene and personal care with brands that help people feel good, look good and get more out of life. Each day, around t...

Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)

...idiabetic Therapies to Treat Type 2 Diabetes," the amount of existing alogliptin clinical data in the alogliptin monotherapy NDA was not sufficient to meet certain statistical requirements outlined in that Guidance. On June 26, the FDA asked Takeda to conduct an additional cardiovascular safety trial that...

Awardees for the 2009 Young Investigator Grant for Probiotics Research Announced

...establishment of the Probiotics Scientific Board in the United States. The Young Investigator Grant for Probiotics Research program was established to meet these goals by contributing to the advancement of probiotics study in the United States. DANONE is the world's leading producer of yogurt pr...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

...are solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals, and consumer health products. Novartis ...

First Potential Lupus-Specific Treatment in Sight

...nitiative entitled, A New 21 (st) Century Approach to Lupus Healthcare , to ensure the ongoing advancement of the science and medicine of lupus to meet the multi-dimensional needs of people with lupus." View a video of Sandra Raymond's remarks on the LFA website . About Lupus ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... Company will continue to face risks related to FDA's approval of the Company's Biologics License Application for ABthrax. If the Company is unable to meet requirements associated with the ABthrax contract, future revenues from the sale of ABthrax to the U.S. Government will not occur. Existing and prospe...

Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

...ion and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intel...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

..."CCR5 antagonists, such as vicriviroc, have a novel mechanism of action and may play a unique role as physicians seek to construct new HIV regimens to meet the specific needs of their patients," said Joseph C. Gathe, Jr., M.D., F.A.C.P., clinical instructor, department of internal medicine, Baylor College...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

...uccessfully complete clinical trials for KRX-0401; our ability to successfully finalize late stage protocols for KRX-0401 with the FDA; our ability to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

...d can be manufactured cost efficiently at commercial scale. We believe our product will be highly attractive to consumers, as it has been designed to meet the market demand for a low cost, fast onset local anesthesia product." Dharma has an end-of-phase 2 meeting scheduled with the Food and Drug Adm...

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

...possibly reducing problematic use. For now, responsibility coupled with expertise, insight, diligence and compassion are among the components that can meet the challenges of opioid use in pain management, the authors agree. A peer-review journal, Mayo Clinic Proceedings publishes original articles ...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

... program "We believe it is an endeavor worthy of strong support. It is hopeful that MARVEL II, which is one stage of the broader MARVEL program, will meet a key efficacy end point - the six-minute walk." Dr. Carl Pepine, MD, Professor of Medicine, University of Florida College of Medicine, discussed t...

Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

...lation pattern. Shire has sufficient supply of velaglucerase alfa to meet anticipated patient demand. Shire is working with the FDA to file a ...e Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the ...

BioCis Pharma Reports Positive Phase IIa Clinical Results in Atopic Dermatitis

...c dermatitis may significantly impair the quality of life of those affected. Existing treatments often have undesirable side effects and do not always meet the needs of patients. BioCis Pharma Ltd. is a Karolinska Development portfolio company. BioCis Pharma Ltd is an innovative drug develop...

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

...ete Response Letter, and at this stage believe they can respond to the issues raised without conducting any additional studies. The Companies plan to meet with the FDA following submission of their response. About Acurox Tablets Acurox is a patented, orally administered, immediate release tabl...

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

...n New Antidiabetic Therapies to Treat Type 2 Diabetes," the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfi...