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Tiny Cup Attached to Eye Improves Drug Delivery For Retinal Diseases

LOS ANGELES, Aug. 7 /PRNewswire-USNewswire/ -- A new drug delivery system that uses a tiny silicone cup filled with any drug and sealed to the outer surface (episclera) of the eyeball may offer a more effective method for the sustained delivery of medicines for retinal and vitreous disea...

Juvenile Diabetes Research Foundation, The Genomics Institute of the Novartis Research Foundation Announce Innovative Diabetes Drug Discovery and Development Partnership

- Program Focuses on Expanding Pipeline of Drugs For People with Type 1 Diabetes - NEW YORK, Aug. 5 /PRNewswire-USNewswire/ -- The Juvenile Diabetes Research Foundation said today that it has entered into a novel collaborative research agreement with the Genomics Institute of th...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

LAVAL, QC, Aug. 5 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS ) today announced it has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada for its novel formulation of the antidepressant trazodone. "We are pleased to file our New Dru...

Popular Breast Cancer Drug Used with Certain Antidepressants Puts New Jersey Women at Risk

FRANKLIN LAKES, N.J., July 30 /PRNewswire-FirstCall/ -- A new analysis finds that women in New Jersey who take the breast cancer drug tamoxifen in conjunction with certain popular antidepressants may be at a higher risk for a breast cancer recurrence. In May, Medco Health Solutions, ...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

THE WOODLANDS, Texas, July 21 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX ), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has received orphan d...

UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201 Phase II of the trial was presented in 2009 ASCO Plenary Session US Oncology, Inc . today announced that US Oncology Research will participate...

Cognition Therapeutics Closes Series A Financing to Advance Drug Candidates for Alzheimer's Disease

PITTSBURGH, July 16 /PRNewswire/ -- Cognition Therapeutics Inc., a Pittsburgh-based drug discovery company developing small molecule disease-modifying treatments for Alzheimer's, has closed on a $1.21M Series A financing. The round was led by Ogden CAP, LLC of New York City and inc...

Cystic Fibrosis - Liposomal Tobramycin Receives Second Orphan Drug Designation Within Weeks

ZURICH, July 16 /PRNewswire/ -- An innovative treatment for infections of the respiratory tract in cystic fibrosis patients has received a second orphan drug designation in the US only weeks after a first designation was granted. The recent designation relates to Burkholderia cepacia pathogens...

Results From Drug Trials and New Risk Factors Announced at International Alzheimer's Conference

VIENNA, July 15 /PRNewswire-USNewswire/ -- This week, more than 3,000 leading scientists convened to report and discuss the latest advances in research on treatments, risk factors, diagnosis and causes for the health epidemic of the 21st century -- Alzheimer's disease -- at the Alzheimer's As...

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

SEATTLE, July 9 /PRNewswire/ -- Dharma Therapeutics, Inc., ("Dharma") Seattle, WA (a subsidiary of the Transcu Group Limited, a company listed on the Singapore Exchange Limited) announced that its improved active transdermal delivery technology, which administers lidocaine and epinephrine through ...

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

FRAZER, Pa., June 30 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH ) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of impro...

HCPC Calls for Greater Healthcare Savings Through Improved Adherence to Prescription Drug Regimens

FALLS CHURCH, Va., June 22 /PRNewswire-USNewswire/ -- With today's announcement that the Pharmaceutical Research and Manufacturers of America (PhRMA) has offered to voluntarily grant some $80 billion in discounts to Medicare beneficiaries over the next decade in an effort to reduce overall healthc...

Families of Spinal Muscular Atrophy Announces Latest Developments on Three SMA Drug Discovery Programs

LIBERTYVILLE, Ill., June 18 /PRNewswire-USNewswire/ -- Families of Spinal Muscular Atrophy has just released details of the latest developments for the Families of SMA funded therapeutic pipeline. Families of SMA is currently funding three distinct drug discovery programs: 1) Quinazolines to ...

CeNeRx BioPharma Obtains Rights to Novel Drug Candidate for Prevention and Treatment of Neurodegeneration Disorders

--Orally Active Enhancer of Human Nerve Growth Factor Has Demonstrated Promising Activity Preclinically-- --Broad Potential Applications Include Neuropathies, Alzheimer's and Huntington's Disease and Others-- RESEARCH TRIANGLE PARK, N.C., June 16 /PRNewswire/ -- CeNeRx BioPharma, Inc., a...

Proteolix, Inc. Drug Candidate, PR-957, Prevents Disease Progression in Rheumatoid Arthritis Models by Selective Inhibition of the Immunoproteasome

Findings Published in Nature Medicine Suggest Broad Implications for the Treatment of Inflammatory and Autoimmune Disorders SOUTH SAN FRANCISCO, Calif., June 15 /PRNewswire/ -- Proteolix, Inc. announced that in an article published today in Nature Medicine, Proteolix's selective immunoprote...

Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride: Oral 162

NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- Novo Nordisk (NVO) data presented today at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily liraglutide, taken as monotherapy, leads to statistically significant and sustained reductions in blood sug...

Investigational Cancer Drug BSI-201 Showed Clinical Benefit in 62% of Patients with Triple-Negative Metastatic Breast Cancer and Significantly Prolonged Survival

PARIS and BRISBANE, California, June 3 /PRNewswire-FirstCall/ -- - Data Highlighted in Plenary Session of 2009 American Society of Clinical Oncology Annual Meeting Sanofi-aventis (EURONEXT: SAN and NYSE: SNY ) and its fully owned subsidiary, BiPar Sciences, today announced resu...

PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

MONTEREY, Calif., June 2 /PRNewswire/ -- This month's Journal of Aerosol Medicine and Pulmonary Drug Delivery features positive Phase Ib clinical trial results for PARI Pharma's L-CsA, inhaled liposomal cyclosporine A. In May, PARI Pharma received Orphan Drug Designation from the Food and Drug Ad...

NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia

Potential Seven Years Market Exclusivity in PHN Pending Product Approval SAN MATEO, Calif., June 2 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX ), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the Offic...

AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria

AMSTERDAM, May 28 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that the European Medicines Agency has granted Orphan Drug Designation to AMT's gene therapy product AMT-021 for the treatment of acute int...

Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-CXCR4 Antibody, MDX-1338

-Clinical study planned for relapsed / refractory acute myelogenous leukemia- PRINCETON, N.J., May 27 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FD...

Unique Cardiovascular Treatment Readied for Global Market: Proprietary Paccocath(R) Technology is the Only Drug Eluting Balloon with Clinical Data

WARRENDALE, Pa., May 18 /PRNewswire/ -- MEDRAD Interventional(TM)/Possis(R) today announced that it has reached key milestones in bringing the Paccocath(R) Technology closer to market as an option for the over 14 million patients in the United States and Europe who suffer from Peripheral Arterial ...

Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever

SAN DIEGO, May 14 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX ) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, Acetavance(TM) (intravenous acetaminophen), for...

Addrenex Pharmaceuticals Expands Product Pipeline by Licensing New Drug to Treat Narcolepsy

DURHAM, N.C., May 13 /PRNewswire/ -- Addrenex Pharmaceuticals today expanded its pipeline of products aimed at adrenergic regulation with the signing of an agreement to license a new drug for the treatment of narcolepsy, a chronic and debilitating sleep disorder, as well as other neurologic and ps...

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...

D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients

REHOVOT, Israel, May 6 /PRNewswire/ -- D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients. D-Pharm plans to initiate ...

Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders

- Company preparing to initiate phase III clinical trial - SOUTH SAN FRANCISCO, Calif. , May 5 /PRNewswire/ -- Hyperion Therapeutics, Inc. today announced that HPN-100 has received orphan product designation from the U.S. Food and Drug Administration for maintenance treatment of patients wit...

Potentia Pharmaceuticals' POT-4 Drug Candidate for Age-Related Macular Degeneration Successfully Completes Phase I Clinical Trial - Prepares for Phase II

POT-4 well tolerated by all subjects and sustained levels of drug reported after one treatment LOUISVILLE, Ky., May 4 /PRNewswire/ -- Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD), announced to...

Cystic Fibrosis - Orphan Drug Designation for Innovative Treatment Against Lung Infections by Axentis Pharma AG

ZURICH, Switzerland, April 30 /PRNewswire/ -- An innovative treatment for infections of the respiratory tract in cystic fibrosis patients has received orphan drug designation in the US. Axentis Pharma of Zurich, Switzerland announced today that this sought-after designation has been granted to...

Adding Steroid Drug to MS Treatment May Reduce Disease Activity

SEATTLE, April 30 /PRNewswire-USNewswire/ -- Using a steroid drug for multiple sclerosis (MS) in addition to an MS drug may reduce the amount of disease activity more than using the MS drug alone, according to a study presented as part of the Late-breaking Science Program at the American Academy o...

Karmanos Cancer Institute Researchers Study New Drug Combinations to Treat Childhood Leukemia

Abstract #4061 DENVER, April 21 /PRNewswire-USNewswire/ -- Scientists from the Barbara Ann Karmanos Cancer Institute in Detroit presented data today at the American Association for Cancer Research's 100th Annual Meeting 2009 that could potentially provide a brighter future for children who su...

Genes Identified That Enhance Tumor Cell Sensitivity to CTI's Cancer Drug Brostallicin

Identifies potential clinical trial strategies for personalized approach to cancer treatment SEATTLE, April 21 /PRNewswire-FirstCall/ -- Systems Medicine, LLC (SM), a wholly-owned subsidiary of Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC), presented data from a preclinical study, whic...

New Australian Drug Holds Hope of Major Breakthrough in Treating Terminal Blood Cancers

SYDNEY, April 20 /PRNewswire/ -- Australian medical research company Immune System Therapeutics Ltd (IST) has launched a clinical trial to test its breakthrough treatment for terminal blood cancers. IST has genetically engineered an antibody drug that binds specifically to a target protein fo...

Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA

UPPSALA, Sweden, April 14 /PRNewswire-FirstCall/ -- Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) for the treatment of ovarian cancer. Orphan Drug designation can entail additional assistance from FDA to expedite and optimize dru...

Premier Research Announces Milestone Investigational New Drug Application

PHILADELPHIA, April 7 /PRNewswire/ -- Premier Research Group Limited, the international pharmaceutical services company, is pleased to announce that it has submitted an Investigational New Drug Application which represents the 50th IND under management. The milestone IND was submitted to the FDA's...

Michael J. Fox Foundation Awards $2.1 Million to Improve Drug Delivery in Parkinson's Disease

NEW YORK, March 27 /PRNewswire-USNewswire/ -- The Michael J. Fox Foundation announced that it has awarded approximately $2.1 million total to seven research teams working to improve drug delivery for Parkinson's disease. The funding was awarded under the Foundation's Improving Delivery of Pa...

Abbott Advances Its Revolutionary Fully Bioabsorbable Drug Eluting Stent With Initiation of Next Phase of Clinical Trial

ABBOTT PARK, Ill., March 24 /PRNewswire-FirstCall/ -- Abbott ( NYSE: ABT ) today announced the initiation of the next phase of the ABSORB clinical trial to evaluate the safety and performance of the company's fully bioabsorbable drug eluting coronary stent. This second phase of the ABSORB clinic...

U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent

Novel Stent Platform Designed for Radial Strength, Flexibility HOUSTON, March 18 /PRNewswire/ -- IDEV Technologies Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive technologies, announced today that the U.S. Food and Drug Administration (FD...

The Lancet Publishes Two-Year Results of Abbott's Fully Bioabsorbable Drug Eluting Stent

Data Demonstrate Bioabsorbable Stent Is Absorbed Within Two Years, Leaving Behind Blood Vessels that Appear to Move and Function Similar to Untreated Vessels ABBOTT PARK, Ill., March 12 /PRNewswire-FirstCall/ -- A comprehensive analysis published today in The Lancet , one of the world's le...

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...
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