Content about Clinical trial

December 6, 2011

A drug made by Pfizer appears to work in treating overactive bladder in elderly patients, according to results of a clinical trial released Monday.

NEW YORK — A drug made by Pfizer appears to work in treating symptoms of overactive bladder in elderly patients, according to results of a clinical trial released Monday.

Pfizer said that results of study A0221049 of the drug Toviaz (fesoterodine fumarate) worked better than placebo in reducing the number of urgency urinary incontinence episodes. The 12-week study enrolled 562 elderly people in the United States. The drug already has Food and Drug Administration approval for treating overactive bladder.

November 28, 2011

Bayer HealthCare and Regeneron Pharmaceuticals have started a late-stage clinical trial in China to evaluate a drug for eye disorders, the companies said Monday.

TARRYTOWN, N.Y. — Bayer HealthCare and Regeneron Pharmaceuticals have started a late-stage clinical trial in China to evaluate a drug for eye disorders, the companies said Monday.

The drug makers announced the start of the phase-3 "SIGHT" trial of Eylea (aflibercept) injection for the treatment of the neovascular form of age-related macular degeneration, also known as wet AMD. The companies said the trial, which will include about 300 patients, will be the largest retinal trial conducted in China.

November 21, 2011

Factor Nutrition Labs on Monday presented a study supporting supplementation with its FocusFactor product to improve brain function before the Gerontological Society of America.

BOSTON — Factor Nutrition Labs on Monday presented a study supporting supplementation with its FocusFactor product to improve brain function before the Gerontological Society of America.

November 18, 2011

A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

SILVER SPRING, Md. — A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

November 17, 2011

Bristol-Myers Squibb and AstraZeneca presented an analysis Wednesday of 14 clinical trials at the American Heart Association's Scientific Sessions in Orlando, Fla., the companies said.

PRINCETON, N.J. — Bristol-Myers Squibb and AstraZeneca presented an analysis Wednesday of 14 clinical trials at the American Heart Association's Scientific Sessions in Orlando, Fla., the companies said.

The phase-2b and phase-3 trials all involved the investigational Type 2 diabetes drug dapagliflozin and, the companies said, showed that use of the drug did not lead to an unacceptable risk to adult patients' cardiovascular health compared with other treatments.

November 17, 2011

GlaxoSmithKline announced the results from the first of eight phase-3 clinical trials that examined the efficacy of albiglutide in the treatment of Type 2 diabetes.

LONDON — GlaxoSmithKline announced the results from the first of eight phase-3 clinical trials that examined the efficacy of albiglutide in the treatment of Type 2 diabetes.

The Harmony 7 trial was a 32-week, head-to-head, open-label, noninferiority study that compared albiglutide, an investigational once weekly glucagon-like peptide-1 agonist, with once-daily liraglutide. According to the results, patients administered GSK's drug saw a 0.78% reduction in HbA1C, while patients administered liraglutide saw a 0.99% reduction in HbA1C.

November 14, 2011

A late-stage clinical trial of a drug under development as a treatment for multiple sclerosis has shown "successful" results.

CAMBRIDGE, Mass. — A late-stage clinical trial of a drug under development as a treatment for multiple sclerosis has shown "successful" results.

Genzyme, acquired earlier this year by French drug maker Sanofi, announced results of the phase-3 "CARE-MS II" trial of Lemtrada (alemtuzumab), saying the drug "significantly reduced" worsening of disability and relapse in patients with MS, compared with Rebif (interferon beta-1a), made by Pfizer and German drug maker Merck KGaA, a separate company from U.S.-based Merck.

November 10, 2011

AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

NEW YORK — AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

November 7, 2011

A large number of patients with a serious form of arthritis experienced improvement in their condition after taking a drug made by Abbott Labs for three months, according to results of a late-stage clinical trial announced Monday.

ABBOTT PARK, Ill. — A large number of patients with a serious form of arthritis experienced improvement in their condition after taking a drug made by Abbott Labs for three months, according to results of a late-stage clinical trial announced Monday.

November 2, 2011

The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

Takeda and Millennium, the Japanese drug maker's cancer-drug subsidiary, announced Tuesday that the FDA approved a supplemental new drug application for the injectable multiple myeloma drug Velcade (bortezomib) that updates its label to include additional data from a clinical study showing that the drug extended patients' survival time.

October 25, 2011

Eli Lilly is withdrawing one of its drugs from the market after clinical trials showed it to be ineffective.

INDIANAPOLIS — Eli Lilly is withdrawing one of its drugs from the market after clinical trials showed it to be ineffective.

The drug maker announced Tuesday the withdrawal of Xigris (drotrecogin alfa [activated]) from all markets following results of the "PROWESS-SHOCK" study, which found that it did not produce a statistically significant reduction in 28-day, all-cause death in patients with septic shock. The company said there were no new findings regarding the drug's safety profile.

October 19, 2011

Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

OSAKA, Japan — Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

October 6, 2011

A drug under investigation by Sanofi for multiple sclerosis improved several measures of disease activity in patients, according to results of a late-stage clinical trial.

PARIS — A drug under investigation by Sanofi for multiple sclerosis improved several measures of disease activity in patients, according to results of a late-stage clinical trial.

September 22, 2011

A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.

CHICAGO — A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.

September 19, 2011

A drug made by Merck for treating HIV infection was effective and tolerated in patients regardless of their gender or race, according to results of a late-stage clinical trial announced Monday.

CHICAGO — A drug made by Merck for treating HIV infection was effective and tolerated in patients regardless of their gender or race, according to results of a late-stage clinical trial announced Monday.

September 15, 2011

GlaxoSmithKline and Amicus Therapeutics have started a late-stage clinical trial for a drug to treat a rare genetic disorder, the companies said.

CRANBURY, N.J. — GlaxoSmithKline and Amicus Therapeutics have started a late-stage clinical trial for a drug to treat a rare genetic disorder, the companies said.

GSK and Amicus announced the start of a second phase-3 trial of Amigal (migalastat hydrochloride) for Fabry disease, a rare lysosomal storage disorder that affects between 5,000 and 10,000 people worldwide. The market for Fabry disease has long been dominated by Genzyme, a subsidiary of French drug maker Sanofi that makes the biologic drug Fabrazyme (agalsidase beta).

August 23, 2011

The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

THOUSAND OAKS, Calif. — The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

August 17, 2011

Patients with gout taking a drug made by Savient Pharmaceuticals experienced "significant" improvements, according to results of two late-stage clinical trials published in the Journal of the American Medical Association.

EAST BRUNSWICK, N.J. — Patients with gout taking a drug made by Savient Pharmaceuticals experienced "significant" improvements, according to results of two late-stage clinical trials published in the Journal of the American Medical Association.

August 15, 2011

Patients taking an experimental treatment for Parkinson's disease experienced greater reduction in symptoms than those taking standard therapies, according to results of a late-stage clinical trial.

HAYWARD, Calif. — Patients taking an experimental treatment for Parkinson's disease experienced greater reduction in symptoms than those taking a drug already on the market, according to results of a late-stage clinical trial.

August 8, 2011

An investigational treatment made by Roche for asthma increased lung function in patients who could not adequately control their disease with inhaled corticosteroids, according to results of a mid-stage clinical trial.

BASEL, Switzerland — An investigational treatment made by Roche for asthma increased lung function in patients who could not adequately control their disease with inhaled corticosteroids, according to results of a mid-stage clinical trial.

August 5, 2011

Amylin Pharmaceuticals and Takeda Pharmaceutical have halted development of a treatment for obesity in mid-stage clinical trials, the two companies said.

SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have halted development of a treatment for obesity in mid-stage clinical trials, the two companies said.

The companies said the decision to discontinue development of a therapy that combines pramlintide and metreleptin was based on "a commercial reassessment of the pramlintide/metreleptin program … [that] took into account a revised development plan, as well as evolving dynamics within he obesity therapeutic area."

August 4, 2011

German drug maker Merck KGaA said it finished enrolling patients in a late-stage clinical study of a drug for Parkinson's disease.

DARMSTADT, Germany — Merck KGaA has finished enrolling patients in a late-stage clinical study of a drug for Parkinson's disease, the German drug maker said.

Merck KGaA, which is a separate company from U.S.-based Merck & Co. and operates in the United States under the name EMD, said 549 patients with mid- to late-stage Parkinson's had enrolled in the phase-3 "SETTLE" study of safinamide. The study is designed to evaluate the drug's safety and efficacy as an add-on therapy to levodopa, a common treatment for Parkinson's.

July 27, 2011

Eli Lilly has launched its physician payment registry, a website that enables visitors to search payments to individual U.S.-based physicians and the institutions or research organizations that receive payments on behalf of a physician.

INDIANAPOLIS — Eli Lilly has launched its physician payment registry, a website that enables visitors to search payments to individual U.S.-based physicians and the institutions or research organizations that receive payments on behalf of a physician.

The drug maker said that its website, which is in line with its corporate integrity agreement with the U.S. government, aims to show how the company works with U.S. physicians and compensates them for their services and how these collaborations benefit patient care.

July 19, 2011

Patients taking an investigative antidepressant undergoing late-stage clinical development showed “significant” improvement, according to study results released Monday.

NEW YORK — Patients taking an investigative antidepressant undergoing late-stage clinical development showed “significant” improvement, according to study results released Monday.

Forest Labs and Pierre Fabre Medicament announced results of a phase-3 trial of levomilnacipran in adults with major depressive disorder. Results showed a statistically significant improvement in patients treated with the drug, compared with those taking placebo.

July 18, 2011

Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

SYDNEY — Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.