Content about Endocrine system

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 19, 2011

An insulin pen for children made by Novo Nordisk has won a design award, the company said Wednesday.

CRAWLEY, England — An insulin pen for children made by Novo Nordisk has won a design award, the company said Wednesday.

The Danish drug maker won the 2010 Good Design Award from the Chicago Athenaeum Museum of Architecture and Design and the European Centre for Architecture, Art, Design and Urban Studies for its NovoPen Echo, used to treat Type 1 diabetes. The annual award, which the two organizations have given since 1950, are the oldest and among the most coveted for design and innovation, Novo Nordisk said.

January 11, 2011

U.S. drug maker Eli Lilly and German drug maker Boehringer Ingelheim will collaborate to develop drugs for diabetes, the companies said Tuesday.

INDIANAPOLIS — U.S. drug maker Eli Lilly and German drug maker Boehringer Ingelheim will collaborate to develop drugs for diabetes, the companies said Tuesday.

The agreement centers around investigative drugs currently in mid- to late-stage clinical development, including two oral drugs made by BI, BI10773 and linagliptin, and two basal insulin analogues made by Lilly, LY2605541 and LY2963016. The deal also includes options to develop and commercialize a Lilly monoclonal antibody.

January 4, 2011

The magazine of the American Diabetes Association has released its annual consumer guide in its January issue.

NEW YORK — The magazine of the American Diabetes Association has released its annual consumer guide in its January issue.

Diabetes Forecast highlighted what's new and on the horizon for the six categories of diabetes-management products, including blood-glucose meters and insulin pens and pumps, as well as diabetes drugs available in the United States, ranked by type and popularity. The guide also spotlighted mobile applications and what devices they can be used for.

January 4, 2011

The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

The drug maker announced on Dec. 29 the approval of Fortesta (testosterone) gel, a treatment for men with low testosterone, which affects nearly 14 million men in the United States.

Endo said it planned to introduce Fortesta in the United States early this year.

January 3, 2011

This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

December 23, 2010

Scientists at the Harvard School of Public Health and collaborators from other institutions have identified a natural substance in dairy fat that substantially may reduce the risk of Type 2 diabetes.

BOSTON — Scientists at the Harvard School of Public Health and collaborators from other institutions have identified a natural substance in dairy fat that substantially may reduce the risk of Type 2 diabetes. 

Reporting in the Dec. 21 issue of the Annals of Internal Medicine, investigators led by Dariush Mozaffarian, associate professor in the Department of Epidemiology at HSPH, explained that the compound trans-palmitoleic acid is a fatty acid found in milk, cheese, yogurt and butter that is not produced by the body.

December 23, 2010

The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

Watson's new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

December 21, 2010

A biopharmaceutical company exclusively will develop and commercialize oral formulations of a drug maker's insulins.

PRINCETON, N.J. — A biopharmaceutical company exclusively will develop and commercialize oral formulations of a drug maker's insulins.

Emisphere will be paid $57.5 million in potential product development and sales milestone payments by Novo Nordisk — of which $5 million dollars will be payable upon signing — as well as royalties on sales. Further financial details of the agreement were not disclosed.

December 13, 2010

In patients with Type 1 diabetes, the islet cells of the pancreas are destroyed, thus eliminating the organ’s ability to produce insulin.

NEW YORK — In patients with Type 1 diabetes, the islet cells of the pancreas are destroyed, thus eliminating the organ’s ability to produce insulin.

But researchers at Georgetown University have found a way to recreate them using cells from the testicles, according to published reports.

WebMD reported that the researchers took the testicular tissue, extracted the stem cells and used them to create new islet cells. Injecting them into the pancreases of mice with diabetes. The researchers found that the cells began to secrete insulin.

December 9, 2010

Combining a diabetes drug marketed by Eli Lilly and Amylin Pharmaceuticals controls blood sugar and promotes weight loss more than insulin alone, according to a new study.

CHAPEL HILL, N.C. — Combining a diabetes drug marketed by Eli Lilly and Amylin Pharmaceuticals controls blood sugar and promotes weight loss more than insulin alone, according to a new study.

December 6, 2010

An investigational drug made by Watson Pharmaceuticals and Columbia Labs reduced the risk of premature birth, according to results of late-stage clinical trial.

MORRISTOWN, N.J. — An investigational drug made by Watson Pharmaceuticals and Columbia Labs reduced the risk of premature birth, according to results of a late-stage clinical trial.

The two companies announced results Monday of a phase-3 trial of Prochieve (progesterone), a vaginal gel, saying that it produced a significant reduction in the number of preterm births. The trial was conducted under a collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health.

December 2, 2010

Merck announced on Thursday it has inked a deal to acquire an insulin maker.

WHITEHOUSE STATION, N.J., and BEVERLY, Mass. (Dec. 2) Merck announced on Thursday it has inked a deal to acquire an insulin maker.

December 2, 2010

Oramed Pharmaceuticals, a developer of oral drug delivery solutions, has published an article in the Journal of Diabetes Science and Technology’s November issue describing evaluation of the company’s glucagon-like peptide (GLP-1) analog formulation (ORMD-0901) in regulating glucose excursions in animal models.

JERUSALEM — Oramed Pharmaceuticals, a developer of oral drug delivery solutions, has published an article in the Journal of Diabetes Science and Technology’s November issue describing evaluation of the company’s glucagon-like peptide (GLP-1) analog formulation (ORMD-0901) in regulating glucose excursions in animal models.

November 24, 2010

Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

INDIANAPOLIS — Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

The FDA approved Axiron (testosterone) topical solution as a treatment for men with various conditions that lead to deficiency of the hormone. The drug, a controlled substance, is designed for application under the arm.

November 15, 2010

A leading charitable funder of and advocate for Type 1 diabetes research and a drug...

NEW YORK and SAN DIEGO — A leading charitable funder of and advocate for Type 1 diabetes research and a drug maker have entered into a research collaboration agreement to provide financial support for a clinical proof-of-concept study to investigate the effects of an analog of the human hormone leptin in patients with Type 1 diabetes.

November 2, 2010

The Food and Drug Administration has turned down an application for an insulin product made...

DANBURY, Conn. The Food and Drug Administration has turned down an application for an insulin product made by Biodel, Biodel said.

 

The drug maker announced that it received a complete response letter from the FDA for Linjeta (human insulin [rDNA origin]) for the treatment of Type 1 and Type 2 diabetes.

 

 

November 2, 2010

The Diabetes Hands Foundation is kicking off an annual initiative, designed to promote exercise and...

November 2, 2010

The CEO of drug maker Eli Lilly has called for a “wave of invention” to...

CLEVELAND The CEO of drug maker Eli Lilly has called for a “wave of invention” to combat diabetes.

Speaking at the Cleveland Clinic Medical Innovation Summit, John Lechleiter said breakthroughs against the disease are needed as urgently today as a century ago, noting that the disease could create a “health and economic time bomb,” as 1-in-3 Americans are forecasted to have the disease by 2050.

 

November 1, 2010

Wegmans on Monday announced the availability of its co-branded blood glucose monitoring systems: Nipro Diagnostics’...

ROCHESTER, N.Y. Wegmans on Monday announced the availability of its co-branded blood-glucose monitoring systems: Nipro Diagnostics’ TrueResult system and True2go.

 

October 21, 2010

The Food and Drug Administration has approved a new contraceptive from Warner Chilcott, the drug...

ARDEE, Ireland The Food and Drug Administration has approved a new contraceptive from Warner Chilcott, the drug maker said Friday.

 

The company said it plans to launch Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) early next year. The company said the contraceptive contains the lowest dosage of estrogen — 10 micrograms — of any oral contraceptive currently available in the U.S. market.

 

 

October 19, 2010

Patients taking a certain class of drugs mostly used for prostate cancer may be at...

SILVER SPRING, Md. Patients taking a certain class of drugs mostly used for prostate cancer may be at higher risk of heart disease and diabetes, the Food and Drug Administration warned on Wednesday.

 

October 17, 2010

Pfizer has entered the world of biosimilars through a deal with India-based Biocon to distribute...

NEW YORK Pfizer has entered the world of biosimilars through a deal with India-based Biocon to distribute versions of insulin and insulin analog products around the world, the companies said Monday.

 

September 30, 2010

UltiMed, a company that makes insulin-delivery devices, has named a new executive....

ST. PAUL, Minn. UltiMed, a company that makes insulin-delivery devices, has named a new executive.

 

The company announced the appointment of Brahim Zabeli as VP diabetes care for the U.S. market. In the new role, Zabeli will manage commercial activity, including sales, marketing and customer service.

 

 

Zabeli previously worked as director of trade and managed markets for medical supply company Becton, Dickinson & Co.

 

September 19, 2010

Insulin-dependent diabetics will be eligible to receive free syringes and pen needles from Price Chopper,...