difficulty

Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstrom's Macroglobulinemia

...o other forms of anticancer therapy; and 3) andthe difficulty encountered thus far in the discovery of drugs thatwill inhibit this pathway without causing excessive toxicity. It isplausible that perifosine may be useful in combination to reducethe resistance to other cancer treatments. To date, over 1,500 pati...

CombinatoRx Product Candidate CRx-150 Shows Activity on DAS28 and Pain, but Not CRP

... modified release formulation of CRx-102,potential difficulty and delays in obtaining regulatory approvalfor the sale and marketing of its product candidates, the Company'sability to obtain additional financing or funding for its researchand development and those other risks that can be found in the"Risk Factor...

CytRx Announces Clinical Results from Its Rising Multiple Dose Trial with Arimoclomol for ALS

...ld be too large for ALSpatients who sometimes have difficulty swallowing." CytRx is presently conducting a follow-up clinical trial inhealthy volunteers to provide longer-term safety and tolerabilityinformation at the 400 mg dose. This double-blind,placebo-controlled study includes 16 healthy volunteers: four ...

Remicade Two Year Data in Ankylosing Spondylitis Show Improvement in Spinal Mobility and Spinal Inflammation

...ICADE. Signs of an allergic reactioninclude hives, difficulty breathing, chest pain, high or low bloodpressure, swelling of face and hands, and fever or chills. Tellyour doctor if you have experienced a severe allergic reaction. Themost common side effects of REMICADE are: respiratory infections,such as sinus i...

Anti-TNF Golimumab Continues to Show Promise in Phase II Rheumatoid Arthritis Study

...of RA include inflammation of the joints,swelling, difficulty moving, and pain. The most commonly affectedjoints are the hands and feet. The joint pain of RA can impact apatient's ability to perform normal daily activities, limit jobopportunities, and make family and household responsibilities achallenge. RA ...

Data Presented at SLEEP 2007 Shows VEC-162 Improves Sleep Onset and Maintenance vs. Placebo

... experience insomnia ofall types, characterized by difficulty falling asleep, wakingfrequently during the night, waking too early and not being able toreturn to sleep, or waking up not feeling refreshed. CircadianRhythm Sleep Disorders (CRSD), one type of insomnia, affectmillions of Americans in a number of for...

Study Demonstrated Rozerem (ramelteon) Does Not Affect Middle-of-the-Night Balance in Older Adults with Insomnia

...ated for the treatment ofinsomnia characterized by difficulty with sleep onset. ROZEREM canbe prescribed for long-term use. ROZEREM is the first and onlyprescription sleep medication that has shown no evidence of abuseor dependence in clinical studies,* and has not been designated asa controlled substance. With...

Additional Data on CombinatoRx Drug Candidates CRx-102 and CRx-139 Presented at EULAR

... modified releaseformulation of CRx-102, potential difficulty and delays inobtaining regulatory approval for the sale and marketing of itsproduct candidates, the Company's ability to obtain additionalfinancing or funding for its research and development and thoseother risks that can be found in the "Risk Factor...

Frova Phase III Study Data Demonstrates That Short-Term Prevention Treatment Reduces Frequency and Severity of Menstrual Migraine

...certainty of marketacceptance of new products; the difficulty of predicting FDAapprovals; risks with respect to technology and productdevelopment; the effect of competing products and prices;uncertainties regarding intellectual property protection;uncertainties as to the outcome of litigation; changes in operat...

IMPAX Presents at Movement Disorder Society's 11th International Congress of Parkinson's Disease and Movement Disorders

...tainsufficient capital to fund its operations, the difficulty ofpredicting FDA filings and approvals, consumer acceptance anddemand for new pharmaceutical products, the impact of competitiveproducts and pricing, IMPAX's ability to successfully develop andcommercialize pharmaceutical products, IMPAX's reliance o...

International Movement Disorder Specialists Receive New Information About the Use of Once-Daily Azilect in the Treatment of Parkinson's Disease

...ion include severe headache, blurred vision, difficulty thinking, seizures, chest pain, unexplained ... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, European MedicinesAgency and other regulatory author...

Novel Mechanism Insights and Additional Data on CombinatoRx Drug Candidates to Be Presented at Upcoming EULAR Meeting

... modified releaseformulation of CRx-102, potential difficulty and delays inobtaining regulatory approval for the sale and marketing of itsproduct candidates, the Company's ability to obtain additionalfinancing or funding for its research and development and thoseother risks that can be found in the "Risk Factor...

Alexza Pharmaceuticals to Present AZ-004 (Staccato Loxapine) Clinical Data at the Annual NCDEU Meeting

...he treatment of sleepdisorder in patients who have difficulty falling asleep. CONTACT: Thomas B. King, Pesident & CEO of AlexzaPharmaceuticals, Inc.,+1-650-687-3900, <a target="_blank" href="mailto:tking@alexza.com">tking@alexza.com Web site: <a target="_blank" href="http://www.alexza.com/"...

NovaDel Announces Positive Data from Two Studies Comparing Zolpidem Oral Spray to Ambien Tablets

...lity sleep and report one or more of thefollowing: difficulty initiating sleep, difficulty maintainingsleep, and waking up too early. According to the "2005 Sleep inAmerica Poll," 54% of thos...

ISTA Pharmaceuticals Announces Positive Preliminary Results from Ecabet Sodium Phase IIb Study

...'s ecabet sodium developmentprogram (including the difficulty of predicting the timing oroutcome of ISTA's product development efforts and the FDA or othergovernmental agency approval or actions); uncertainties and risksregarding market acceptance of ISTA's approved products and theimpact of competitive product...

Topline Results of Phase III Study in Acute Ischemic Stroke (Dias-2) Do Not Demonstrate Difference Between Desmoteplase and Placebo

... a number of risks and uncertainties, includingthe difficulty of predicting FDA approvals, the acceptance anddemand for new pharmaceutical products, the impact of competitiveproducts and pricing, the timely development and launch of newproducts, and the risk factors listed from time to time in theForest Laborat...

Alexza Pharmaceuticals to Present AZ-001 Phase IIb Clinical Data at the American Headache Society Meeting

...he treatment of sleepdisorder in patients who have difficulty falling asleep. CONTACT: Thomas B. King, President & CEO of AlexzaPharmaceuticals, Inc.,+1-650-687-3900, <a target="_blank" href="mailto:tking@alexza.com">tking@alexza.com Web site: <a target="_blank" href="http://www.alexza.com/...

Study Suggests Strattera Improved ADHD Symptoms in Patients With Comorbid Alcohol Abuse

... third of patients with ADHD inadulthood will have difficulty with emotional dysregulation,(2)which can include emotional overactivity, temper, rapidly changingemotions, decreased ability to handle routine stress and frequentfeelings of being overwhelmed.(2) Additionally, many people withADHD also suffer from a...

Long-Term Extension of Ulcerative Colitis Study Shows Remicade Responders Maintained Improvement Through Two Years of Follow-Up

...ICADE. Signs of an allergic reactioninclude hives, difficulty breathing, chest pain, high or low bloodpressure, swelling of face and hands, and fever or chills. Tellyour doctor if you have experienced a severe allergic reaction. Themost common side effects of REMICADE are: respiratory infections,such as sinus i...

New Study Suggests no Significant Impairment in Middle-of-the-Night Balance, Mobility or Memory in Older Adults Using Ramelteon

...der adults suffering from insomniacharacterized by difficulty with sleep onset," said Zammit. "Thetrial will als...ated for the treatment of insomniacharacterized by difficulty with sleep onset. Ramelteon can beprescribed for long-term use. Ramelteon is the first and onlypresc...

AEterna Zentaris' Partner, Spectrum, Discloses Detailed Phase 2 Data for Ozarelix, in BPH at Annual AUA Meeting

...ofthe urethra, resulting in increased frequency or difficulty inurinating. Enlargement of the prostate is controlled bytestosterone. According to the National Institutes of Health, BPHaffects more than 50% of men over the age of 60 and as many as 90%of men over the age of 70. Treatment options for BPH includesu...

Northfield Laboratories Reports Results of Pivotal Phase III Trauma Study

...atient died. The medical literature documents the difficulty of making anaccurate diagnosis of MI in trauma patients for multiple reasons,including direct trauma to the chest. Myocardial infarction andmyocardial ischemia are traditionally assessed by EKGs and thecardiac enzymes Troponin I and CK-MB, both of wh...

Ozarelix Phase 2 Data in Benign Prostatic Hypertrophy Presented at Annual Meeting of American Urological Association

...of the urethra,resulting in increased frequency or difficulty in urinating.Treatment options for BPH include surgery and medications to reducethe amount of tissue and increase the flow of urine. Currenttreatment options have limited efficacy, leading to inadequatecompliance. Medications currently available belo...

Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study for Milnacipran as a Treatment for Fibromyalgia Syndrome

... a number of risks and uncertainties, includingthe difficulty of predicting FDA approvals, the acceptance anddemand for new pharmaceutical products, the impact of competitiveproducts and pricing, the timely development and launch of newproducts, and the risk factors listed from time to time in theForest Laborat...

FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.

... representations tohealth care providers about the difficulty of extracting oxycodone,the active ingredient, from the OxyContin tablet; trained its salesforce to represent to health care providers that OxyContin did notcause euphoria and was less addictive than immediate-releaseopiates; and allowed health care ...

Benicar HCT Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril

...r treatment, whichusually can be continued without difficulty once the blood pressurehas stabilized. Impaired Renal Function In studies of ACE inhibitors in patients with unilateral orbilateral renal artery stenosis, increases in serum creatinine orblood urea nitrogen (BUN) have been reported. There has been ...

Data Presented at ASH Demonstrate Nebivolol Lowers Blood Pressure as Long-Term Monotherapy and in Combination Therapy

... a number of risks and uncertainties, includingthe difficulty of predicting FDA approvals, the acceptance anddemand for new pharmaceutical products, the impact of competitiveproducts and pricing, the timely development and launch of newproducts, and the risk factors listed from time to time in theForest Laborat...

New Survey Finds Troubling Data on American Asthma Sufferers

...ath (29 percent), coughing (28 percent), and difficulty falling or staying asleep (28 percent) on a weekly...e or extremely severe coughing (20 percent), difficulty breathing (19 percent), wheezing (18 percent), tightness in chest (18 percent) and diffi...

ISTA Pharmaceuticals Announces Statistically Significant Preliminary Results From its U.S. Phase II/III Clinical Study Of Bepotastine

...STA's product development activities(including the difficulty of predicting the timing or outcome ofbepotastine development efforts, clinical testing or studies, orFDA or other regulatory agency approval or actions); uncertaintiesand risks regarding market acceptance of ISTA's approved productsand the impact of...

Treatment with Copaxone Plus Minocycline Showed Substantial Reduction of Disease Activity in Patients with Active Relapsing-Remitting Multiple Sclerosis

... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, European MedicinesAgency and other regulatory authority approvals, the regulatoryenvironment and changes in the health policies and structures ofvarious countries, our ability to achieve expected result...

Treatment with Copaxone Plus Minocycline Showed Substantial Reduction of Disease Activity in Patients with Active Relapsing-Remitting Multiple Sclerosis

... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, Eu... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, European MedicinesAgency and other regulatory author...

Copaxone Treatment over Two Years after Short Term Induction with Mitoxantrone Provided Sustained Benefits to Active Relapsing-Remitting Multiple Sclerosis Patients

... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, European MedicinesAgency and other regulatory authority approvals, the regulatoryenvironment and changes in the health policies and structures ofvarious countries, our ability to achieve expected result...

Data Suggest Cymbalta Reduced Severity of Night Pain in Patients with Diabetic Nerve Pain

...ch as daytime sleepiness,drowsiness, grogginess or difficulty awakening) or who were onother sedating medication...erve pain often complain of beingawoken, or having difficulty falling asleep because of pain, and itis difficult for physicians to know whether sleep problems are...

Laquinimod, a Novel Oral Compound, Showed Significant Reduction in Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS)

... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, European MedicinesAgency and other regulatory authority approvals, the regulatoryenvironment and changes in the health policies and structures ofvarious countries, our ability to achieve expected result...

Data Published in Neurology Showed That Higher Dose of Copaxone Increased Efficacy in Relapsing-Remitting Multiple Sclerosis (RRMS)

... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, European MedicinesAgency and other regulatory authority approvals, the regulatoryenvironment and changes in the health policies and structures ofvarious countries, our ability to achieve expected result...

CombinatoRx to Present Combination High Throughput Screening (cHTS) Data at Upcoming AACR Meeting

...nism of action of ourproduct candidates, potential difficulty and delays in obtainingregulatory approval for the sale and marketing of its productcandidates, the Company's ability to obtain additional funding forits research and development and those other risks that can befound in the "Risk Factors" section of...

Cequent Pharmaceuticals Founder to Present tkRNAi Technology at the American Association of Cancer Research Annual Meeting in Los Angeles

...ased on its high specificity and potency. Onemajor difficulty impeding the wider development of RNAi-basedtherapies, however, is the need to deliver the molecules triggeringRNAi (short interfering RNA) into the target cells and diseasedtissues. Cequent's tkRNAi technology offers an elegant "Trojanhorse" solutio...

Idenix Reports Results from Two Phase IIb Studies of the Combination of Valopicitabine and Pegylated Interferon in Hepatitis C Genotype-1 Patients at the 42nd Annual Meeting of the European Association for the Study of the Liver

..."These data are significant as they underscore the difficulty inretreating patients who have failed standard of care," said NezamAfdhal, M.D., chief of hepatology and director of the liver center,Beth Israel Deaconess Medical Center. "There was a significantantiviral response to the combination of valopicitabin...

Newest Adult Stem Therapy Treats Diabetes

...roper insulin levels,as well as for those who have difficulty accessing appropriatehealth care," Weldon concluded. Dave Weldon CONTACT: Kurt Heath of the Office of Representative DaveWeldon,+1-202-225-3671 or +1-202-210-3844 Web site: <a target="_blank" href="http://weldon.house.gov/">http://weldon.h...

First Pharmacoeconomic Analysis with Long-Term Data Showed Copaxone Was More Cost-Effective Than Interferon Beta Therapies for Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)

... thatcould affect the pharmaceutical industry, the difficulty ofpredicting U.S. Food and Drug Administration, European MedicinesAgency and other regulatory authority approvals, the regulatoryenvironment and changes in the health policies and structures ofvarious countries, our ability to achieve expected result...

Once Daily, Extended-Release Ropinirole Improves Parkinson's Symptoms in Patients not Optimally Controlled With Levodopa

...atient's medication, it can beproblematic, causing difficulty with simple activities and movementin patients with Parkinson's disease," said Rajesh Pahwa, M.D.,Professor of Neurology, Director, Parkinson Disease and MovementDisorder Center, University of Kansas Medical Center, Kansas City,Kan., and lead investi...

CombinatoRx Provides Topline Results from Phase 2 RA Study with CRx-139 and Very Low Dose Prednisolone

...nism of action of our productcandidates, potential difficulty and delays in obtaining regulatoryapproval for the sale and marketing of its product candidates, theCompany's ability to obtain additional funding for its research anddevelopment and those other risks that can be found in the "RiskFactors" section of...

Scios Announces Results From Exploratory Nesiritide Study Providing Important New Renal and Mortality Safety Data with a Neutral Effect on the Primary Endpoint

...ed treatment for ADHF that hasshown improvement in difficulty breathing and reduction of elevatedwedge pressures in the lungs in controlled clinical trials.NATRECOR(R) has been studied in 16 prospective clinical trialsinvolving 2,012 patients treated with the drug, and has been usedto treat more than 800,000 ac...

Cholesterol Drug Fails to Slow Progression of Coronary Disease, Cleveland Clinic Study Reports

...drugs. These findings furtherdemonstrate the great difficulty in developing therapies to disruptthe atherosclerotic disease process." The development of drugs to raise HDL has been a key researchpriority because, despite lowering LDL (low-density lipoprotein, or"bad") cholesterol with statin drugs, many pati...