Content about Clinical trial

May 24, 2012

The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don't take their drugs as prescribed, or don't take them at all.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don't take their drugs as prescribed, or don't take them at all.

May 22, 2012

Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker's plans to seek approval for a nail fungus treatment.

SAN DIEGO — Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker's plans to seek approval for a nail fungus treatment.

May 16, 2012

An experimental kidney cancer drug made by Pfizer didn't extend the time in which patients survived without their disease worsening when compared with a competing drug, according to results of a late-stage clinical trial released Wednesday.

NEW YORK — An experimental kidney cancer drug made by Pfizer didn't extend the time in which patients survived without their disease worsening when compared with a competing drug, according to results of a late-stage clinical trial released Wednesday.

May 9, 2012

Seattle Genetics and Takeda's cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.

BOTHELL, Wash. — Seattle Genetics and Takeda's cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.

Seattle Genetics and Millennium announced the start of a phase-3 trial of Adcetris (brentuximab vedotin) in patients relapsed cutaneous T-cell lymphoma that expresses the CD30 cell membrane protein. The study will enroll more than 120 patients who will be divided into two groups, one of which will receive Adcetris and another that will receive methotrexate or bexarotene.

April 26, 2012

The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

March 30, 2012

Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.

SOUTH SAN FRANCISCO, Calif. — Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.

March 21, 2012

A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

March 16, 2012

Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

March 15, 2012

A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

JERUSALEM — A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

Teva and Active announced the publication of results of the phase-3 "Allegro" study of oral laquinimod in the March 15 issue of the New England Journal of Medicine. The study was conducted in 24 countries and enrolled 1,106 patients with MS who received 0.6 mg of laquinimod per day or placebo.

March 12, 2012

Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

PARSIPPANY, N.J. — Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

Watson announced the initiation of a phase-3 trial of Esmya (ulitristal acetate) in women who have anemia due to uterine leimyomas, also known as uterine fibroids, which causes benign solid tumors that can lead to excessive menstrual bleeding, anemia and pain and may require surgery. Watson is developing the drug under a licensing agreement with Gedeon Richter.

March 6, 2012

Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

CAMBRIDGE, Mass. — Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

The unit, Millennium, announced the start of a phase-3 trial to evaluate MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma, an aggressive non-Hodgkin's lymphoma.

March 5, 2012

A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

JERUSALEM — A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

Teva said a 529-patient phase-3 trial of Qnasl (beclomethasone dipropionate) nasal aerosol showed the drug produced a "significant" improvement in patients with seasonal and perennial allergies. Patients received either 320 mcg of Qnasl or a placebo.

February 29, 2012

Accordant Health Services, a CVS Caremark company, and the Michael J. Fox Foundation for Parkinson's Research on Wednesday announced a collaboration to provide to patients with Parkinson's disease who are enrolled in Accordant-sponsored care management programs information about resources available through the foundation.

WOONSOCKET, R.I., and NEW YORK  — Accordant Health Services, a CVS Caremark company, and the Michael J. Fox Foundation for Parkinson's Research on Wednesday announced a collaboration to provide to patients with Parkinson's disease who are enrolled in Accordant-sponsored care management programs information about resources available through the foundation.

February 27, 2012

The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

February 16, 2012

The global market for celiac disease is expected to grow substantially over the decade as more people are diagnosed with the condition, according to a new report.

LONDON — The global market for celiac disease is expected to grow substantially over the decade as more people are diagnosed with the condition, according to a new report.

The report, by British market research firm GlobalData, found that the global celiac disease therapeutics market would be worth more than $512 million by 2017 and $664.4 million by 2019.

January 23, 2012

A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

Columbia Labs and Watson Pharmaceuticals announced that the FDA's Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.

January 19, 2012

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

January 18, 2012

The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

KNOXVILLE, Tenn. — The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

Provectus is planning to start a phase-3 trial of the investigational drug PV-10 for melanoma that has spread to other parts of the body, and said the FDA told the company that a meeting with the agency in addition to the one they had in October would not be required.

January 17, 2012

A late-stage clinical trial to evaluate a drug in Alzheimer's disease patients came up short, the drug's developers said Tuesday.

NEW YORK — A late-stage clinical trial to evaluate a drug in Alzheimer's disease patients came up short, the drug's developers said Tuesday, prompting them to cease its development.

Pfizer and Medivation announced results of the phase-3 "CONCERT" trial of Dimebon (latrepirdine), a trial that had lasted 12 months and enrolled 1,003 patients worldwide. The drug, which the companies have studied since 2009, was originally developed by Soviet Union scientists in the 1980s as an antihistamine.

January 10, 2012

Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

LAKE FOREST, Ill. — Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

The company said the phase-3 trial of biosimilar EPO (erythropoietin) would compare its product with Amgen's Epogen in patients with kidney dysfunction who have anemia. The trial, which will enroll about 1,000 patients who already have taken Epogen, follows a phase-1 trial that ended last year, and results of the late-stage trial are expected next year.

December 22, 2011

A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-marketing clinical study program.

NEW YORK — A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-market clinical study program.

December 21, 2011

An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.

CAMBRIDGE, Mass. — An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.

Genzyme, owned by French drug maker Sanofi, compared the once-daily drug teriflunomide with Rebif (interferon beta-1a), made by Pfizer and Merck KGaA, in patients with relapsing MS in the 324-patient "TENERE" trial. Merck KGaA, based in Germany, operates under the name EMD Serono in the United States to avoid confusion with U.S.-based Merck & Co.

December 16, 2011

A drug made by Pfizer shows "significant" benefit to patients with restless legs syndrome, according to results of a late-stage clinical trial announced Friday.

NEW YORK — A drug made by Pfizer shows "significant" benefit to patients with restless legs syndrome, according to results of a late-stage clinical trial announced Friday.

The drug maker said Lyrica (pregabalin) produced statistically significant improvements in patients with RLS compared with placebo and pramipexole after 12 weeks of treatment. In the phase-3 study, A0081186, 300 mg of Lyrica, 0.25 mg of pramipexole, 0.5 mg of pramipexole or placebo was given to patients on a daily basis.

December 9, 2011

Diplomat Specialty Pharmacy has signed an agreement with a provider of acquisition and management services for oral cancer drugs that the companies said would allow for better access to the drugs and related programs.

SAN DIEGO — Diplomat Specialty Pharmacy has signed an agreement with a provider of acquisition and management services for oral cancer drugs that the companies said would allow for better access to the drugs and related programs.

RainTree Oncology Services announced the agreement with Flint, Mich.-based Diplomat, saying it was building a network of community oncologists through which members will obtain drugs at contracted prices and that the agreement would improve access to clinical and medication management programs.

December 7, 2011

A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug's developer said Wednesday.

RYE, N.Y. — A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug's developer said Wednesday.

Curemark announced results of the phase-3 trial of CM-AT in children ages 3 to 8 years. The company said the drug had a statistically significant effect on symptoms of autism compared with placebo. The Food and Drug Administration has granted the drug fast-track status, which it does for investigational drugs to treat serious or life-threatening conditions that may address unmet medical needs.