Content about Clinical trial

January 6, 2011

Patients with one or more out of four chronic diseases studied who take their medications as prescribed may save the healthcare system as much as $7,800 per patient annually, according to findings of a new CVS Caremark study analyzing annual pharmacy and medical costs over a three-year period.

WOONSOCKET, R.I. — Patients with one or more out of four chronic diseases studied who take their medications as prescribed may save the healthcare system as much as $7,800 per patient annually, according to findings of a new CVS Caremark study analyzing annual pharmacy and medical costs over a three-year period.

January 5, 2011

The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

CLINTON, N.J. — The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

Drug maker Ikaria said Wednesday that the FDA had extended pediatric exclusivity period for the drug Inomax (nitric oxide) from January 2013 to July 2013.

Ikaria said the extension was based on results of a clinical study of the drug in preterm infants with bronchopulmonary dysplasia, a serious condition that results from lung injury.

December 29, 2010

Recent news that the FDA has rejected Teva's application for a new lower-dose version of multiple sclerosis drug Copaxone likely will hold off the emergence of a generic version of the drug.

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.

A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.

December 16, 2010

Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

December 14, 2010

Eli Lilly is suspending a late-stage clinical trial of a cancer drug amid safety concerns, the drug maker said Monday.

INDIANAPOLIS — Eli Lilly is suspending a late-stage clinical trial of a cancer drug amid safety concerns, the drug maker said Monday.

The company had been conducting a phase-3 trial of the pharmaceutical drug tasisulam as a second-line treatment for patients with melanoma whose cancer could not be removed or had spread to other parts of the body. Melanoma, the deadliest form of skin cancer, is diagnosed in 68,000 people in the Untied States every year, according to the American Cancer Society.

December 3, 2010

Good results from an investigational diabetes drug made by Spherix may result from higher body mass indexes among U.S. patients, according to results of a late-stage clinical trial announced Thursday.

BETHESDA, Md. — Good results from an investigational diabetes drug made by Spherix may result from higher body mass indexes among U.S. patients, according to results of a late-stage clinical trial announced Thursday.

Spherix said results of the phase-3 trial conducted among American and Indian patients indicated that D-tagatose may be more effective in lowering HbA1c levels due to Americans having higher BMIs on average than Indians.

December 1, 2010

Drug maker Keryx Biopharmaceuticals got promising results from a late-stage clinical trial of a drug for treating elevated phosphate levels, also known as hyperphosphatemia, in patients on kidney dialysis, the company said Tuesday.

NEW YORK — Drug maker Keryx Biopharmaceuticals got promising results from a late-stage clinical trial of a drug for treating elevated phosphate levels, also known as hyperphosphatemia, in patients on kidney dialysis, the company said Tuesday.

In a phase-3 trial, Zerenex (ferric citrate) significantly reduced phosphate levels in patients with end-stage kidney disease on dialysis.

November 18, 2010

Pfizer got promising results from a late-stage clinical trial of a cancer treatment, the drug...

NEW YORK — Pfizer got promising results from a late-stage clinical trial of a cancer treatment, the drug maker said Friday.

 

Pfizer announced results of the phase-3 “AXIS 1032” trial of the kidney cancer drug axitinib, saying that it “significantly” extended the lives of patients with advanced renal cell carcinoma compared with Nexavar (sorafenib), made by Bayer HealthCare and Onyx Pharmaceuticals.

 

 

November 15, 2010

An investigative treatment for allergies made by Teva Pharmaceutical Industries appears to work, according to...

JERUSALEM — An investigative treatment for allergies made by Teva Pharmaceutical Industries appears to work, according to results of a late-stage clinical trial released Monday.

 

Teva said phase-3 data from a study of Qnaze HFA (beclomethasone dipropionate), designed to be inhaled through the nose, was effective in treating patients with seasonal allergic rhinitis, while safety results were similar to those for placebo. Data from the study were presented at the annual meeting of the American College of Allergy, Asthma & Immunology in Phoenix.

November 14, 2010

A drug made by Pfizer may help decrease the risk of cardiovascular death or heart...

CHICAGO — A drug made by Pfizer may help decrease the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, according to a late-stage clinical study.

The “Emphasis-HF” study — funded by Pfizer, published online in the New England Journal of Medicine and presented at the American Heart Association scientific sessions in Chicago — found that adding Inspra (eplerenone) to standard therapies reduced the risks compared with placebo.

November 8, 2010

Two drug makers conducting a late-stage clinical trial of a drug for treating overweight and...

SAN DIEGO Two drug makers conducting a late-stage clinical trial of a drug for treating overweight and obese patients said the drug produced significant weight loss in patients with Type 2 diabetes.

 

Arena Pharmaceuticals and Eisai reported results of the one-year “BLOOM-DM” phase-3 trial of the drug lorcaserin, showing that a significant number of patients lost 5% to 10% of their weight by the end of the trial. Patients taking the drug also showed improvements in blood sugar levels, compared with those taking placebo.

 

November 8, 2010

Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of...

MAPLE GROVE, Minn. Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of a drug for treating epilepsy, the company said Tuesday.

 

Upsher-Smith announced an additional study for patients who completed the phase-3 “Prevail” trial of the drug USL255 (topiramate extended-release). The drug is designed to provide a once-daily dosage for adults with the disease.

 

 

November 7, 2010

Patients with rheumatoid arthritis derive about as much benefit from a weekly injection of a...

NEW YORK Patients with rheumatoid arthritis derive about as much benefit from a weekly injection of a biotech drug made by Bristol-Myers Squibb for the disease as they do from receiving it via IV on a monthly basis, according to late-stage clinical trial data released Monday.

November 4, 2010

An investigative treatment for hepatitis C got strong results in patients who had failed previous...

BOSTON An investigative treatment for hepatitis C got strong results in patients who had failed previous treatments or who were new to treatment, according to results of a late-stage clinical trial program announced this week.

November 3, 2010

Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report...

WASHINGTON Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report by the main lobby for the pharmaceutical industry.

 

The Pharmaceutical Research and Manufacturers of America said 98 medicines for dementia, mostly Alzheimer’s, were in clinical trials or under review by the Food and Drug Administration.

 

 

November 1, 2010

Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration...

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.” 

November 1, 2010

The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent...

WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.

November 1, 2010

A recent study of diabetes information shared on Facebook raised questions about the accuracy of...

WOONSOCKET, R.I. A recent study of diabetes information shared on Facebook raised questions about the accuracy of the information on social media sites and its sources, according to the research sponsored by CVS Caremark.

 

October 31, 2010

The U.S. subsidiary of a Swiss biotech company has started a late-stage trial of a...

October 28, 2010

Vivus found itself foiled in its efforts to market a drug for obesity as the...

MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.

 

October 25, 2010

Drug maker Keryx Biopharmaceuticals has finished enrolling participants for a late-stage clinical trial of a...

NEW YORK Drug maker Keryx Biopharmaceuticals has finished enrolling participants for a late-stage clinical trial of a drug for patients on kidney dialysis, Keryx said Tuesday.

 

The company is conducting a phase-3 trial of Zerenex (ferric citrate) in patients with end-stage kidney disease on dialysis who have excessive phosphorous levels, a condition known as hyperphosphatemia.

 

 

Keryx said it expects to complete the study and report top-line data by the end of the year.

 

October 11, 2010

The Food and Drug Administration has turned down an application from a company seeking approval...

PALO ALTO, Calif. The Food and Drug Administration has turned down an application from a company seeking approval for a drug to treat fibromyalgia.

 

Jazz Pharmaceuticals announced Monday that the FDA had given it a complete response letter for the drug JZP-6 (sodium oxybate), citing a need for additional clinical studies and issues concerning the appropriate patient population, ensuring safe use, a proposed risk evaluation and mitigation strategy, and others.

 

 

October 3, 2010

The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson...

RARITAN, N.J. The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson for a drug to treat chronic pain, J&J said Monday.

 

September 30, 2010

Teva Pharmaceutical Industries and Active Biotech announced promising results from a mid-stage trial of laquinimod,...