Content about Clinical trial

July 10, 2013

DSN had the opportunity to speak with Christian Tadrus, who has been the pharmacist at Sam’s Health Mart in the Colombia, Mo. area, since 1997. Tadrus, a member of McKesson’s Sponsored Clinical Services pharmacy network, participates in a number of adherence support programs, including the award-winning Pharmacy Intervention adherence coaching program, StudyLink patient recruitment for clinical trials program, and the RxRapid Response pharmacist survey program.

DSN had the opportunity to speak with Christian Tadrus, who has been the pharmacist at Sam’s Health Mart in the Colombia, Mo. area, since 1997.

March 12, 2014

The Pharmaceutical Research and Manufacturers of America and the National Minority Quality Forum announced on Wednesday a first-of-its-kind national campaign to help increase diversity in clinical trials.

WASHINGTON — The Pharmaceutical Research and Manufacturers of America and the National Minority Quality Forum announced on Wednesday a first-of-its-kind national campaign to help increase diversity in clinical trials.

January 15, 2014

Drug maker AbbVie has started a late-stage clinical trial of an experimental drug for treating triple-negative breast cancer, the company said Wednesday.

NORTH CHICAGO, Ill. – Drug maker AbbVie has started a late-stage clinical trial of an experimental drug for treating triple-negative breast cancer, the company said Wednesday.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.

December 23, 2013

Two experimental drugs under development by Biogen Idec are effective in reducing bleeding episodes in patients with two forms of hemophilia when administered as a preventive treatment, while also reducing the need for frequent injections, according to late-stage clinical trial data.

NEW YORK — Two experimental drugs under development by Biogen Idec are effective in reducing bleeding episodes in patients with two forms of hemophilia when administered as a preventive treatment, while also reducing the need for frequent injections, according to late-stage clinical trial data.

December 23, 2013

In two separate clinical trials, researchers at Albert Einstein College of Medicine of Yeshiva University have found that periodic meetings with a lactation consultant encourages women traditionally resistant to breast-feeding to do so, at least for a few months, or long enough for mother and child to gain health benefits.

NEW YORK — In two separate clinical trials, researchers at Albert Einstein College of Medicine of Yeshiva University have found that periodic meetings with a lactation consultant encourages women traditionally resistant to breast-feeding to do so, at least for a few months, or long enough for mother and child to gain health benefits. The results of the trials were published online last week in American Journal of Public Health.

December 16, 2013

A drug made by Novartis extends the lives of patients with a life-threatening blood cancer to a greater extent than conventional therapy or placebo, according to results of a late-stage clinical trial.

BASEL, Switzerland — A drug marketed by Novartis and Incyte Corp. extends the lives of patients with a life-threatening blood cancer to a greater extent than conventional therapy or placebo, according to results of a late-stage clinical trial.

Novartis announced the results of two phase-3 studies of Jakavi (ruxolitinib) in patients with myelofibrosis, presenting them at the American Society of Hematology's annual meeting and exposition in New Orleans.

December 10, 2013

NEW YORK — Absorption Pharmaceuticals will be conducting clinical trials with Kaiser to measure the efficacy of the company's over-the-counter solution for PE Promescent, CNBC reported Tuesday.

NEW YORK — Absorption Pharmaceuticals will be conducting clinical trials with Kaiser to measure the efficacy of the company's over-the-counter solution for PE Promescent, CNBC reported Tuesday. 

Beginning next week, Kaiser will follow 150 men who suffer from premature ejaculation and will be given either Promescent or a placebo over the course of the next year. Patients are being recruited from the San Diego and Los Angeles markets, according to the report.  

December 9, 2013

An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

MAPLE GROVE, Minn. — An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

November 21, 2013

The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

NEW YORK — The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

The companies said the FDA issued a complete-response letter for cariprazine. The agency issues a complete-response letter when it has finished reviewing an application but issues remain that preclude final approval. In the letter, the FDA acknowledged the drug's efficacy, but wanted more clinical trial data.

November 5, 2013

A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

LAKE FOREST, Ill. — A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

October 31, 2013

A personalized medicine company said a new study justifies clinical use of pharmacogenomic testing to help predict patients' response to psychiatric medications and improve treatment outcomes.

MASON, Ohio — A personalized medicine company said a new study justifies clinical use of pharmacogenomic testing to help predict patients' response to psychiatric medications and improve treatment outcomes.

October 24, 2013

An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

October 4, 2013

A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

SANTA CLARA, Calif. — A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

The company said that breakthrough clinical trial results for the game, called PatientPartner," documented for the first time the effectiveness of a story-driven game in changing health behavior and biomarkers. The study was conducted among 100 nonadherence patients at Hershey, Pa.-based Pinnacle Health Systems and presented at the Health2.0 Conference Wednesday in Santa Clara, Calif.

August 8, 2013

For traditional retail pharmacies, one of the biggest roadblocks to entry into the specialty arena is the limited availability of many complex medicines.

For traditional retail pharmacies, one of the biggest roadblocks to entry into the specialty arena is the limited availability of many complex medicines. More and more of these high-ticket, high-touch drugs are entering the market via very restricted and exclusive networks as pharmaceutical manufacturers increasingly demand that the pharmacies dispensing those medicines demonstrate advanced clinical, documentation and patient-support capabilities, including the ability to improve adherence rates, conduct risk evaluation and mitigation strategies, and manage and monitor patient outcomes.

July 2, 2013

Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

HOLZKIRCHEN, Germany — Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started a phase-3 trial of biosimilar etanercept, a knock-off version of Amgen's Enbrel, used to treat chronic plaque-type psoriasis.

June 25, 2013

Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

NEW YORK — Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

In a draft guidance released Friday, the FDA said that due to the efficacy profile of Allergan's drug for dry eyes Restasis (cyclosporine) ophthalmic emulsion, it wouldn't be effective for companies to conduct clinical trials to determine the efficacy of a generic version.

June 17, 2013

One of the greatest challenges facing the pharmaceutical industry today is medication nonadherence — a fact that has not gone unnoticed by McKesson.

A variety of pharmacy-based solutions, designed to help pharmacy owners drive better results both from a patient outcomes and a profitability standpoint by offering services that promote long-term adherence and opportunities for patients to enroll in clinical trials, will be on display for ideaShare attendees through McKesson’s Clinical Services network.

SCOTTSDALE, Ariz. — One of the greatest challenges facing the pharmaceutical industry today is medication non-adherence — a fact that has not gone unnoticed by McKesson.

A variety of pharmacy-based solutions, designed to help pharmacy owners drive better results both from a patient outcomes and a profitability standpoint by offering services that promote long-term adherence and opportunities for patients to enroll in clinical trials, will be on display for ideaShare attendees through McKesson’s Clinical Services network.

June 13, 2013

Drug maker Actavis is working with nonprofit pharmaceutical company Medicines360 to make low-cost intrauterine devices available to women, the two said.

PARSIPPANY, N.J. — Drug maker Actavis is working with nonprofit pharmaceutical company Medicines360 to make low-cost intrauterine devices available to women, the two said.

April 12, 2013

The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

April 8, 2013

An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients' conditions, according to results of a late-stage clinical trial.

NEW YORK — An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients' conditions, according to results of a late-stage clinical trial.

AstraZeneca announced initial results of the phase-3 "OSKIRA-1" trial of fostamatinib, which it calls the first oral spleen tyrosine kinase inhibitor in development for RA.

April 5, 2013

GlaxoSmithKline has started a late-stage clinical trial of a drug in patients with an inflammatory disease that affects the blood vessels.

LONDON — GlaxoSmithKline has started a late-stage clinical trial of a drug in patients with an inflammatory disease that affects the blood vessels.

The drug maker announced the start of a phase-3 trial of Benlysta (belimumab) in patients with vasculitis, a condition in which the body's immune system attacks blood vessels, leading to inflammation, disruption of blood flow and possible damage to the organs. The drug is being tested in patients with a common form of the disease known as anti-neutrophil cytoplasmic antibodies-positive vasculitis.

February 12, 2013

Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

MCLEAN, Va. — Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

While much attention on medication adherence has focused on patients not taking the already approved drugs prescribed to them or not taking them properly, the new study, released Tuesday by Consumer Health Information, found problems with adherence in clinical trials as well.

January 3, 2013

An experimental drug for Lou Gehrig's disease made by Biogen Idec has failed in a late-stage clinical trial, the drug maker said.

WESTON, Mass. — An experimental drug for Lou Gehrig's disease made by Biogen Idec has failed in a late-stage clinical trial, the drug maker said Thursday.

Biogen announced results of its phase-3 trial of dexpramipexole in patients with the disease, known technically as amyotrophic lateral sclerosis, or ALS. The drug failed to improve functioning and survival in patients and failed to show efficacy in key secondary endpoints as well, the company said.

December 3, 2012

Merck has started a clinical trial that it hopes will eventually enroll 1,700 patients to evaluate an experimental drug for Alzheimer's disease, the company said.

WHITEHOUSE STATION, N.J. — Merck has started a clinical trial that it hopes will eventually enroll 1,700 patients to evaluate an experimental drug for Alzheimer's disease, the company said.

Merck announced the start of "EPOCH," a combined phase-2 and phase-3 study of the drug MK-8931, a 78-week trial in which patients will take either the drug in the 12-mg, 40-mg or 60-mg doses or placebo.