Content about Clinical trial

July 18, 2011

Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

MAPLE GROVE, Minn. — Upsher-Smith Labs has started a late-stage clinical trial of a drug for treating patients with a rare and severe form of epilepsy, the drug maker said Monday.

June 1, 2011

The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.

HERZLIYA, Israel — The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.

XTL announced that the FDA had granted the designation to its recombinant human erythropoietin, or rHuEPO drug, for which the company soon will start phase-2 clinical trials.

The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States per year.

May 17, 2011

A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

SILVER SPRING, Md. — A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

May 17, 2011

An investigational drug made by InterMune improved breathing in patients with a rare and fatal lung disease, according to results of a late-stage clinical trial published online in The Lancet last week.

BRISBANE, Calif. — An investigational drug made by InterMune improved breathing in patients with a rare and fatal lung disease, according to results of a late-stage clinical trial published online in The Lancet last week.

InterMune is investigating the drug pirfenidone as a treatment for idiopathic pulmonary fibrosis, which affects more than 200,000 patients in the European Union and the United States combined. Only 20% of patients with IPF survive after five years.

May 13, 2011

More than 800 drugs are in development for diseases that affect women, according to a pharmaceutical industry lobbying group.

WASHINGTON — More than 800 drugs are in development for diseases that affect women, according to a pharmaceutical industry lobbying group.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

HAYWARD, Calif. — The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

Impax Pharmaceuticals, as the division is known, said it filed an investigational new drug application with the Food and Drug Administration for IPX159 and started a phase-1 study.

April 27, 2011

An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

PARIS — An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

The phase-3 trial combined the drug Zaltrap (aflibercept) with a combination of the chemotherapy drugs folinic acid (leucovorin), 5-fluorouracil and irinotecan, also known as the FOLFIRI regimen.

April 18, 2011

A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

NEW YORK — A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

Keryx Biopharmaceuticals and Torii Pharmaceutical, the pharmaceuticals subsidiary of Japan Tobacco, started a phase-3 trial of Zerenex (ferric citrate) in Japan for patients with hyperphosphatemia. The drug also is in phase-3 trials in the United States as a treatment for hyperphosphatemia in patients with end-stage kidney disease on dialysis.

April 11, 2011

A drug originally developed by scientists in the Soviet Union to treat allergies and currently under investigation by Pfizer and Medivation did not yield significant results in a late-stage clinical trial of patients with Huntington disease, a disorder that leads to cognitive decline, the companies said Monday.

NEW YORK — A drug originally developed by scientists in the Soviet Union to treat allergies and currently under investigation by Pfizer and Medivation did not yield significant results in a late-stage clinical trial of patients with Huntington disease, a disorder that leads to cognitive decline, the companies said Monday.

April 1, 2011

An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

HAYWARD, Calif. — An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it would present data from a phase-3 trial of extended-release IPX066 (carbidopa-levodopa) at the American Academy of Neurology Conference’s annual meeting in Hawaii, which takes place from April 9 through April 16.

The company also said there were no unexpected serious side effects observed in patients.

March 24, 2011

Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

PRINCETON, N.J. — Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

The company said its phase-3 trial for investigational compound ipilimumab, designed for previously untreated patients that were diagnosed with metastatic melanoma, improved overall survival. The study compared the combination of ipilimumab 10 mg/kg and chemotherapy (dacarbazine) with chemotherapy alone.

March 17, 2011

Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

March 16, 2011

Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.

SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.

The drug makers stopped the phase-2 trial of a combination of pramlintide and metreleptin due to problems that arose in two patients related to metreleptin. Amylin said the decision to suspend the trial did not affect its investigations of metreleptin as a treatment of diabetes and hypertriglyceridemia in patients with lipodystrophy.

March 15, 2011

A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

CAMBRIDGE, Mass. — A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

March 14, 2011

A drug maker focused on development and commercialization of diabetes treatments unveiled its accelerating clinical development plans of two drug candidates.

DANBURY, Conn. — A drug maker focused on development and commercialization of diabetes treatments unveiled its accelerating clinical development plans of two drug candidates.

Biodel said BIOD-105 and BIOD-107, known as ultra rapid-acting insulins, are designed to result in more rapid insulin action, compared with currently marketed mealtime insulin analogs.

March 7, 2011

Late-stage clinical trial data for a Keryx Biopharmaceuticals drug to treat kidney disease will be presented at a medical conference in Las Vegas.

NEW YORK — Late-stage clinical trial data for a Keryx Biopharmaceuticals drug to treat kidney disease will be presented at a medical conference in Las Vegas.

Keryx said Monday that phase-3 data for the drug Zerenex (ferric citrate), a drug for abnormally high phosphate levels in patients with end-stage kidney disease on dialysis, will be presented at the upcoming National Kidney Foundation spring clinical meetings in April.

The company announced “positive” results from a phase-3 trial of the drug in November.

February 25, 2011

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.

February 9, 2011

An investigational drug made by Teva Pharmaceutical Industries for treating allergies is safe and effective, according to results of a late-stage clinical trial announced Wednesday.

JERUSALEM — An investigational drug made by Teva Pharmaceutical Industries for treating allergies is safe and effective, according to results of a late-stage clinical trial announced Wednesday.

Teva said the phase-3 trial of the nasally inhaled drug Qnaze (beclomethasone dipropionate) showed that it significantly relieved symptoms of seasonal and perennial allergic rhinitis compared with placebo while demonstrating a similar safety profile.

February 4, 2011

A drug designed to treat an eye condition caused by diabetes may provide a long-term option for patients, according to Alimera Sciences.

ATLANTA — A drug designed to treat an eye condition caused by diabetes may provide a long-term option for patients, according to Alimera Sciences.

Alimera said in two three-year, phase-3 pivotal clinical trials — collectively known as the FAME Study — of Iluvien, which is designed to treat diabetic macular edema, the drug improved visual acuity among patients.

January 25, 2011

Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

WOODCLIFF LAKE, N.J. — Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

Eisai said a phase-3 trial of the drug eritoran found the drug did not significantly reduce mortality in patients with the condition compared with placebo.

Severe sepsis causes about 215,000 deaths in the United States every year, with a mortality rate of about 30%.

January 24, 2011

The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

SAN DIEGO — The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

Optimer announced Monday the FDA’s acceptance of its approval application for fidaxomicin for treating clostridium difficile infection, or CDI. CDI is a colon infection that is a particular problem in hospitals, long-term care centers and in the broader community. It is estimated to affect more than 700,000 people per year. The agency has granted the application priority review and expects to finish its review by May 30.

January 24, 2011

An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

MOUNTAIN VIEW, Calif. — An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

Alexza Pharmaceuticals announced results of a phase-3 trial of the inhaled drug AZ-004 (loxapine), which showed statistically significant improvement in symptoms of agitation in patients compared with the placebo.

January 21, 2011

A drug for major depressive disorder worked better than placebo, according to results of a late-stage clinical trial announced Thursday.

NEW YORK — A drug for major depressive disorder worked better than placebo, according to results of a late-stage clinical trial announced Thursday.

U.S. drug maker Forest Labs and French drug maker Pierre Fabre Medicament said that while the overall difference between patients treated with levomilnacipran and those treated with the placebo was not statistically significant, the drug consistently demonstrated improvement relative to the placebo over the course of the phase-3 trial.

January 20, 2011

It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

January 18, 2011

Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

POINT RICHMOND, Calif. — Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

Transcept sent in its application for Intermezzo (zolpidem tartrate), a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.