UNC Charlotte To Evaluate Potential Adjuvant Activity Of ImmuneRegen's Viprovex(R) With Cancer Vaccine
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), today announces a collaborative relationship with the University of North Carolina at Charlotte to evaluate ImmuneRegen's Viprovex as a possible cancer-vaccine adjuvant. Adjuvants are agents that stimulate and, subsequently, augment the immune system's response to a foreign antigen. The studies will be under the direction of Pinku Mukherjee, Ph.D.
Statins May Decrease Incidence Of Delirium After Cardiac Surgery
A study featured in the January 2009 issue of Anesthesiology offers some of the first evidence that the use of cholesterol-lowering statins before cardiac surgery decreases the odds of postoperative delirium in elderly patients. Previous studies have demonstrated that statins decrease the incidence of morbidity and mortality after cardiac and major non-cardiac surgery. Statins have also been shown to be protective in central nervous system injury.
POZEN Announces Positive Top Line Results For Its PN 400 Phase 3 Trials
POZEN Inc. (NASDAQ: POZN), today announced positive Phase 3 trial results for its PN 400 product candidate (enteric coated naproxen 500 mg and immediate release esomeprazole 20 mg) conducted by POZEN under an agreed Special Protocol Assessment with the FDA. Both the PN 400-301/302 studies achieved the primary endpoints.
The Best CROs bring a “big picture” Perspective
The key benefit of having a full service CRO is their ability to asses and expand risk management and to encompass a broader range of risk issues.
Inspire Initiates Special Protocol Assessment Process For ProlacriaT Trial For Dry Eye
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today it has submitted a clinical protocol and request for Special Protocol Assessment (SPA) to the U.S. Food and Drug Administration (FDA) for a pivotal Phase 3 environmental trial with ProlacriaT (diquafosol tetrasodium ophthalmic solution) for the treatment of dry eye disease.
Medtronic's Third-Generation Endeavor® Resolute Drug-Eluting Stent Maintains Strong Efficacy And Safety Profile At Two Years
Of those treated with the Endeavor® Resolute drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT), in the RESOLUTE IDE trial only two patients required repeat procedures - a remarkably low 1.5 percent rate of target lesion revascularization (TLR) - at two years following implant, according to data released today at the Transcatheter Cardiovascular Therapeutics (TCT) meeting.
SOLX Receives FDA 510(k) Clearance For New Glaucoma Laser
SOLX, Inc. announced U.S. Food and Drug (FDA) 510(k) clearance for the SOLX 790 to perform Titanium:Sapphire laser trabeculoplasty (TLT).
Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).
Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.
Merck & Co., Inc. And Japan Tobacco Inc. Sign Licensing Agreement For Novel Osteoanabolic Drug Candidate To Treat Osteoporosis
Merck & Co., Inc. and Japan Tobacco Inc. (JT) (TSE: 2914) today announced a worldwide licensing agreement to develop and commercialize JTT-305, an investigational oral osteoanabolic (bone growth stimulating) agent for the treatment of osteoporosis, a disease which reduces bone density and strength and results in an increased risk of bone fractures. Under the terms of the agreement, Merck gains worldwide rights, except for Japan, to develop and commercialize JTT-305.
FDA Approves Duramed's Synthetic Conjugated Estrogens A Vaginal Cream
Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream. SCE-A Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.
Bilcare GCS Expands Phase III Clinical Trial Service Capabilities
As part of its commitment to providing its customers with comprehensive services that span the entire clinical supply chain, Bilcare Global Clinical Supplies, a leading single-source provider of clinical trial supplies and services, has enhanced its global Phase III capabilities. Its latest Phase III investments include the upgrade of its Kalish large-scale bottling line at its U.S.
Clinical outsourcing and current trends: How are they affecting business?
The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990’s to over US$17 billion in 2007.
Topigen Completes Enrollment Of Phase II Study Of TPI ASM8 In Asthma
TOPIGEN Pharmaceuticals Inc., a clinical-stage biopharmaceutical company specialized in developing products for respiratory disorders, has announced the completion of patient enrollment in a Phase II safety and efficacy study in asthma with one of its lead product candidates, TPI ASM8. The current clinical study builds on prior efficacy and safety data in a three-day study of TPI ASM8 in an allergen challenge model.
PAION's Partner Lundbeck Initiates Clinical Phase III Trials With Desmoteplase In Ischaemic Stroke
The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8; London AIM: PAI) reports that its licensing partner H. Lundbeck A/S announced the initiation of a clinical Phase III programme with Desmoteplase in the treatment of acute ischemic stroke. The programme consists of two Phase III clinical placebo-controlled trials, each enrolling approximately 320 patients.
Study Sheds Light On The Mechanisms Of Increased Risk Of HIV Infection In The Step HIV Vaccine Trial
A study published today online in The Journal of Experimental Medicine sheds light on the potential mechanisms responsible for the increased incidence of HIV infection that was observed in the failed STEP HIV vaccine trial in 2007. Through the development of an experimental in vitro model, the study shows that the immune complexes formed by antibodies and the adenovirus vector (the Trojan horse for the delivery of the vaccine) induce a strong activation signal of key cells, i.e.
Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.
With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.
Addrenex Pharmaceuticals Initiates Phase 2 Trial On Its Novel Hypertension Drug, ADX415
Addrenex Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its Investigational New Drug Application (IND) for ADX415, a novel hypertension drug. With the approval, Addrenex has launched a phase 2 clinical trial to study ADX415 as a targeted therapy for hypertension. The phase 2 trial is a multicenter, double-blind, placebo-controlled, dose-ranging study that will involve 80 patients.
VEGF Trap-Eye Final Phase 2 Results In Age-related Macular Degeneration Presented At 2008 Retina Society Meeting
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG announced that VEGF Trap-Eye achieved durable improvements in visual acuity and in biologic measures of neovascular disease, including retinal thickness and active choroidal neovascularization lesion size, for up to one year in a Phase 2 study in the neovascular form of Age-related Macular Degeneration (wet AMD).
ZymoGenetics Presents Interim IL-21 Phase 2 Results In Renal Cell Cancer
ZymoGenetics, Inc. (NASDAQ: ZGEN) presented interim results today from a Phase 2 clinical trial evaluating Interleukin 21 (IL-21) in combination with Nexavar® (sorafenib) tablets in patients with metastatic renal cell cancer. Outpatient therapy with IL-21 and Nexavar as a second or third-line therapy for metastatic renal cell cancer was associated with anti-tumor activity, with manageable side effects.
Anestvice Pressure Controller (APC), is build to maintain the pre-set constant pressure in the cuff throughout the surgery despite of the factors influencing and/or altering this parameter.
Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) ...
Potential Treatment To Prevent Relapse To Methamphetamine Abuse
A new study at the U.S. Department of Energy's (DOE) Brookhaven National Laboratory suggests that vigabatrin (a.k.a. gamma vinyl-GABA, or GVG) blocks drug-seeking behavior in animals previously trained to associate methamphetamine with a particular environment. Specifically, animals pre-treated with vigabatrin lost interest in spending time in a location where they had previously been given methamphetamine.
Sangamo BioSciences Announces Nature Biotechnology Study Demonstrating The Use Of Zinc Finger Nucleases To Generate HIV Resistant T Cells
Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced the publication of data demonstrating that human immune system cells (CD4 T-cells) can be made resistant to HIV infection by treatment with zinc finger DNA-binding protein nucleases (ZFN(TM)). The data suggest that the ZFN approach, which results in the permanent modification of the CCR5 gene encoding an important receptor for HIV infection, is a promising strategy for the treatment of HIV/AIDS.
EVAR Offers Better Results Than Open Repair In High Risk Patients
Endovascular aneurysm repair (EVAR) yields better results than open surgical repair (OSR) in high risk patients with similar costs, according to a one-year trial study which appears in the October issue of the Journal of Vascular Surgery, published by the Society for Vascular Surgery. Data was collected from 342 patients who had an abdominal aortic aneurysm (AAA) of more than 5.
CROs in the new millennium
The Clinical Research Organization industry has reached a new level of development in clinical trials. There are now more than twelve hundred CROs with the greatest number existing in Europe, followed by North America and Asia.
Watson Announces Positive Data For RAPAFLO(TM)(silodosin), Its Investigational Product For BPH, At Regional AUA Conferences
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced that investigators presented efficacy and safety data on silodosin, its investigational treatment for benign prostatic hyperplasia (BPH, or prostate enlargement), at two regional meetings of the American Urological Association (AUA). The trade name for silodosin will be RAPAFLO(TM).
Peregrine Pharmaceuticals Completes Patient Enrollment In First Stage Of Its Second Bavituximab Phase II Breast Cancer Trial
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that it has completed enrollment in the first stage of a Phase II trial of bavituximab in combination with chemotherapy in patients with advanced breast cancer. This is Peregrine's second Phase II study for the treatment of breast cancer.
Landmark Study Shows Thrombolytic Treatment Improves Outcomes In Stroke When Given Up To 4.5 Hours After Symptom Onset
Thrombolytic treatment with Actilyse (alteplase; Boehringer Ingelheim) significantly reduces the risk of patients with mild to moderate stroke being left with any residual disability when given within 4.5 hours of symptom onset - extending the time for administration beyond the currently licensed three hours - according to a major study reported at the recent
Anestvise Inc will Create New Jobs at New Manufacturing Facility in Eastern Europe
Anestvice Inc. www.anestvice.com , whose customers include major pharmaceutical industry players, specializes in manufacturing of medical devices...
ORMD 0901 Is Being Developed As An Oral Dosage Form Of A GLP1-Analog Aimed At Improving Glycemic Control In Adults With Type 2 Diabetes
Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of oral drug delivery systems, announced that it has launched pre-clinical trials of ORMD 0901, a GLP1-analog. ORMD 0901 belongs to the Incretin family of drugs which helps to manage diabetes, including reduction in blood glucose levels and inhibiting glucagon secretion.
EchoCRT Study Will Investigate Benefits Of Cardiac Resynchronization Therapy In Patients With Heart Failure
BIOTRONIK announced the enrollment of the first patient into the EchoCRT (Echocardiography guided Cardiac Resynchronization Therapy) study. Drs William T. Abraham and Ralph Augostini at The Ohio State University Medical Center in Columbus, Ohio, USA, enrolled and implanted the Lumax HF-T CRT-D device in the first patients in EchoCRT.
Head-to-Head Study Demonstrates Focalin(R) XR Offers Faster And Better Symptom Control Than Concerta(R)1 In Early Part Of ADHD Patients' Day
A head-to-head study, published in the June Journal of Child and Adolescent Psychopharmacology, confirms that Focalin(R) XR (dexmethylphenidate HCl) extended-release capsules offer greater improvements in managing symptoms of Attention Deficit/Hyperactivity Disorder compared with Concerta(R) (d,l- methylphenidate HCl) extended-release tablets at two hours post-dose, the primary study endpoint.
Clinical Research Professionals are Still in Demand despite the World Economic Crisis
Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to overcome, but the truth is that everybody working in this industry had to start somewhere and as the industry grows positions need to be filled.
Bionovo Reports On Metabolic Studies Related To Its Menopausal Hot Flash Drug Candidate
Bionovo, Inc. (Nasdaq: BNVI) announced the publishing of a paper in the journal for the American Society for Pharmacology and Experimental Therapeutics, Drug Metabolism and Disposition, entitled "Oxidative In Vitro Metabolism of Liquiritigenin, a Bioactive Compound Isolated from the Chinese Herbal Selective Estrogen Beta-Receptor Agonist MF101.
New Results On World's Most Clinically Advanced Malaria Vaccine Candidate To Be Reported In NEJM
Results from two new studies on the efficacy of the world's most clinically advanced malaria vaccine candidate in infants and young children in Africa was announced at a telephone press briefing on December 8, 2008.
Continuous Glucose Monitoring Improves Blood Sugar Control
Patients with type 1 diabetes who used continuous glucose monitoring (CGM) devices to help manage their disease experienced significant improvements in blood sugar control, according to initial results of a major multicenter clinical trial funded by the Juvenile Diabetes Research Foundation.
Esploron is one of the innovative companies within the CRO industry.
Esploron www.esploron.com is one of the innovative companies within the CRO industry.
HomeCARE II: BIOTRONIK Launches Clinical Study Using Inovative Sensor Technology To Monitor Lung Fluid In Patients With Heart Failure
BIOTRONIK, the pioneer in remote monitoring technologies for patients with cardiac devices, announced today the launch of the HomeCARE II study. The first patient was enrolled at the University Hospital in WĂĽrzburg, Germany which marks the start of this important clinical program. As a pioneer in telecardiology, BIOTRONIK is setting the scientific direction for clinical investigation of remote monitoring of heart failure patients with cardiac devices.
Neurobiological Technologies Reaches Patient Enrollment Target For Interim Analysis Of Viprinex(TM) Phase 3 Stroke Trials
Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII) announced that enrollment into its two Phase 3 pivotal studies evaluating Viprinex(TM) (ancrod) for the treatment of acute ischemic stroke has reached the level of patients necessary to conduct a planned interim analysis across the two studies. NTI is currently studying whether Viprinex is safe and effective for treating acute ischemic stroke when given within six hours of stroke onset.
Clinical Trial Focuses On New Drug For Solid Cancer Tumors And NHL
Researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial, which aims to evaluate a new treatment for solid cancer tumors and non-Hodgkin's lymphoma (NHL) in combination with a chemotherapy agent called cyclophosphamide. CINJ is a center of excellence of UMDNJ-Robert Wood Johnson Medical School.
Anestvice Inc. Phase II Clinical Trials for PC-LM Device have been successfully completed.
The research was conducted on 24 patients ranging in age from 13 to 74 years (the average age was 46.6 ±5.4), who underwent surgery in the urology clinic of the Rostov State Medical University. It was sponsored by Anestvice Inc...
Phase 2 Study Of DM-5689 For The Treatment Of Moderate-To-Severe Menopausal Hot Flashes
Depomed, Inc. (Nasdaq:DEPO) announced the presentation of data from its Phase 2 study of DM-5689 (formerly referred to as Gabapentin GR®) for the treatment of women with moderate-to-severe menopausal hot flashes. As previously disclosed, DM-5689 significantly reduced the frequency and severity of hot flashes from baseline to the end of treatment compared to placebo in the 124 patient study.
Medivation Completes Enrollment Of Phase 1-2 Trial Of MDV3100 In Castration-Resistant Prostate Cancer Patients
Medivation, Inc. (Nasdaq: MDVN) announced that it has completed patient enrollment in a Phase 1-2 dose-escalation clinical trial of MDV3100, its novel androgen receptor antagonist, in castration-resistant prostate cancer patients, and that it will seek approval from the U.S. Food and Drug Administration (FDA) to advance to Phase 3 clinical trials next year. The open-label, U.S.
The First And Only Patch For Preventing Nausea And Vomiting In Cancer Patients Undergoing Chemotherapy
ProStrakan Group plc (LSE: PSK) has announced the U.S. Food and Drug Administration (F.D.A) approval of SANCUSO® (Granisetron Transdermal System), the first and only patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen. Chemotherapy-induced nausea and vomiting (CINV) are commonly cited by patients undergoing chemotherapy as highly feared side effects.
CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published
A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof.
Prevention Of Organ Rejection In Stable Kidney Transplant Patients - LCP-TacroT Moves Into Clinical Phase 3
LifeCycle Pharma A/S (OMX:LCP) today announced the enrollment of the first patient in it's Phase 3 clinical trial program for use of LCP-TacroT in the prevention of organ rejection in stable kidney transplant patients. The clinical trial protocol has been reviewed by FDA, and LCP expects to enroll approximately 300 stable kidney transplant patients in the program. The study will be conducted at approximately 50 sites in U.S.
Long Acting Neuraminidase Inhibitor (LANI) Phase II Completed - Phase III Scheduled -Naturally Acquired Influenza A Or B
Biota Holdings Limited (ASX:BTA)(PINK:BTAHY) announced that its second generation, influenza treatment, CS-8958, has successfully completed its initial Phase II clinical evaluation, showing favourable outcomes against all measured endpoints. The initial Phase III trial is scheduled to commence later this year. CS-8958 is a long acting neuraminidase inhibitor (LANI), and is co-owned with Daiichi-Sankyo Company Limited (TYO:4758)(PINK:DSKYF).
Benefits Of Early HIV Testing And Treatment For Infected Infants
Testing very young babies for HIV and giving antiretroviral therapy (ART) immediately to those found infected with the virus dramatically prevents illness and death, according to a report in the New England Journal of Medicine.
CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published
A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof.
Neurologix Initiates Recruitment For Phase 2 Parkinson's Disease Trial
Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative gene therapies for the brain and central nervous system, announced that it has received Institutional Review Board approvals to begin recruiting and enrolling participants for its Phase 2 clinical trial of the company's gene transfer approach to the treatment of advanced Parkinson's disease.
Herceptin Given Prior To Surgery Improves The Chance Of Survival Without Relapse For Women With HER2-positive Breast Cancer
Standard one year Herceptin treatment provides long-term benefit to patients with high risk of recurrence About 70% of women with locally advanced HER2-positive breast cancer were free of their disease three years after initiation of therapy when treated with Herceptin plus chemotherapy before surgery, compared to only around 50% of patients receiving pre-operative chemotherapy alone.
More Minority Physicians Would Help Improve Minorities' Participation In Clinical Trials, Opinion Piece Says
"The first step in addressing the underrepresentation of black Americans in research ... is to recruit more minority physicians into clinical research," Ken Getz -- chair of the Center for Information and Study on Clinical Research Participation and a senior research fellow at Tufts University
Accurate Data Management can be the make or break for the success of the clinical trial.
It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial.
Reduction Of Frown Lines - Mentor Corporation Announces Completion Of PurTox(R) 3A Study
Mentor Corporation (NYSE:MNT), a leading supplier of medical products for the global aesthetic market, today announced completion of the first of three Phase 3 clinical trials with its purified botulinum Type A neurotoxin (PurTox®) for the reduction of glabellar rhytides (frown lines). This newly completed study involved 400 subjects at ten investigational sites in the United States. Subjects received a single treatment with PurTox or placebo.
HIV Drug Maraviroc Effective For Drug-Resistant Patients
As many as one quarter of HIV patients have drug resistance, limiting their treatment options and raising their risk for AIDS and death. Now, maraviroc, the first of a new class of HIV drugs called CCR5 receptor antagonists, has been shown to be effective over 48 weeks for drug-resistant patients with R5 HIV-1, a variation of the virus found in more than half of HIV-infected patients.
First-Ever National Ranking Of "Hot Spots" For Peripheral Artery Disease (P.A.D.) Identifies Cities With Higher Risk
According to research conducted by the National Minority Quality Forum (NMQF), Detroit tops the list of P.A.D. "Hot Spots" as the city with the highest rate of Peripheral Artery Disease (P.A.D.), a condition that more than doubles the risk of having a heart attack or stroke and more than quadruples the risk of dying from heart disease. P.A.D. "Hot Spots" is the first geographic ranking of P.A.D. prevalence across the United States. "P.A.
Streamlining the process of Clinical Trials
The process of clinical trials can be costly to say the least. Clinical affairs consumes an average of 37% of R&D budgets.
True, False Or Unproven? Medical Myths For The Holiday Season
In a study published in the Christmas 2008 issue of the British Medical Journal, Aaron Carroll, M.D., M.S., and Rachel Vreeman, M.D., M.S., of the Indiana University School of Medicine, explore the science behind six myths commonly associated with the holidays yet relevant year-round. Sugar makes kids hyperactive. Suicides increase over the holidays. Poinsettias are toxic.
Triple Antiplatelet Therapy Appears Superior To Dual Antiplatelet Therapy
Results of five research studies and a clinical registry first-report presentation scheduled for the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), suggest that triple antiplatelet therapy for patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents achieves greater platelet inhibition than conventional dual antiplatelet therapy.
Eating Fish May Prevent Memory Loss And Stroke In Old Age
Eating tuna and other types of fish may help lower the risk of cognitive decline and stroke in healthy older adults, according to a study published in the August 5, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology. For the study, 3,660 people age 65 and older underwent brain scans to detect silent brain infarcts, or small lesions in the brain that can cause loss of thinking skills, stroke or dementia.
Clinqua Inc. has embraced the concept that cooperation with other aspiring companies is the key to unlocking success in the clinical and biopharmaceutical research industry.
Clinqua is a Contract Research Organization www.clinqua.com that is attempting to change the age old notions that plagued the Clinical and Biopharmaceutical Industry, where in the past it was believed that for a company to survive it had to exist in competition with all others.
ICON Enhances Its ICOPhone Technology Platform - New EPRO Module Reduces Implementation Timelines For Collection Of Patient Data
ICON plc (NASDAQ: ICLR; ISIN: IE0001827041) a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the release of an enhanced version of ICOPhoneT, ICON's technology platform for the delivery of Voice and Web Response (IVR/IWR) services.
Basilea Pharmaceutica Opens U.S. Phase III Study On Alitretinoin For The Treatment Of Severe Chronic Hand Eczema
Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that it has opened a clinical phase III study on alitretinoin in the U.S. The "HANDEL" trial (HAND Eczema research of aLitretinoin) is the first ever multi-centered, controlled clinical study for patients with severe chronic hand eczema (CHE) performed in the U.S. "There is a real sense of excitement within the dermatology community with the start of this important trial," said Dr.
Cochrane Review Evaluates Herbal Medicine From Schwabe Pharmaceuticals For Acute Respiratory Tract Infections
A recent report by the internationally renowned, independent Cochrane Collaboration adds further weight to the growing international popularity of standardized Pelargonium sidoides extract EPs® 7630 (Umckaloabo®) in the treatment of acute respiratory tract infections such as acute bronchitis and the common cold.
Legal Issues in Clinical Research
Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval.
New Study Finds Publication Bias Among Trials Submitted To FDA
A quarter of drug trials submitted in support of new drug applications to the US Food and Drug Administration (FDA) remain unpublished five years after the fact, says new research published in the open access journal PLoS Medicine.
Karo Bio: Successful Phase II Study Expands The Potential For Eprotirome In Dyslipidemia Treatment
Karo Bio (STO:KARO) has successfully completed a 10 week phase IIb study with eprotirome given to dyslipidemia patients undergoing treatment with the cholesterol absorption inhibitor ezetimibe. Eprotirome induced a statistically significant and clinically relevant lowering of serum LDL-cholesterol, triglycerides and lipoprotein(a) and was safe and well tolerated. Data show that eprotirome in combination with ezetimibe can become an important treatment option for patients with dyslipidemia.Viev all previous articles...
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