Content about Endocrine system

August 13, 2012

The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

FRAZER, Pa. — The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

Teva Women's Health, part of Israeli drug maker Teva Pharmaceutical Industries, announced the FDA's acceptance of its application for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol), which the company called the first ascending-dose, extended regimen oral contraceptive for preventing pregnancy.

July 26, 2012

Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., on Wednesday introduced the Designer Anabolic Steroid Control Act, a bill that will protect consumers by providing the Drug Enforcement Administration with new enforcement tools to identify and quickly respond when new designer anabolic steroids are created and marketed as dietary supplements.

WASHINGTON — Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., on Wednesday introduced the Designer Anabolic Steroid Control Act, a bill that will protect consumers by providing the Drug Enforcement Administration with new enforcement tools to identify and quickly respond when new designer anabolic steroids are created and marketed as dietary supplements.

July 19, 2012

Roche on Wednesday announced that it has received clearance from the Food and Drug Administration for its Accu-Chek Combo system for insulin pump therapy.

INDIANAPOLIS — Roche on Wednesday announced that it has received clearance from the Food and Drug Administration for its Accu-Chek Combo system for insulin pump therapy.

June 29, 2012

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Shionogi for treating vulvar and vaginal atrophy due to menopause.

FLORHAM PARK, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Shionogi for treating vulvar and vaginal atrophy due to menopause.

Shionogi, the U.S. division of Japanese drug maker Shionogi & Co., said Wednesday that the FDA had accepted for review its application for ospemifene, which the company touts as potentially the first oral alternative to vaginal estrogen treatments.

June 21, 2012

An integrated wellness team approach to diabetes care can help patients not only improve their condition, but also lower their prescription costs, according to new research presented at the American Association of Clinical Endocrinologists’ 21st annual Scientific and Clinical Congress in Philadelphia.


An integrated wellness team approach to diabetes care can help patients not only improve their condition, but also lower their prescription costs, according to new research presented at the American Association of Clinical Endocrinologists’ 21st annual Scientific and Clinical Congress in Philadelphia.


June 15, 2012

A study recently published in the Endocrine Society’s Journal of Clinical Endocrinology and Metabolism suggests that vitamin D — when taken with calcium — can reduce the rate of mortality in seniors, thereby providing a possible means of increasing life expectancy, the society reported Friday.

CHEVY CHASE, Md. — A study recently published in the Endocrine Society’s Journal of Clinical Endocrinology and Metabolism suggests that vitamin D — when taken with calcium — can reduce the rate of mortality in seniors, thereby providing a possible means of increasing life expectancy, the society reported Friday.

March 2, 2012

A generic drug maker has launched its version of an Abbott Labs drug.

JERUSALEM — A generic drug maker has launched its version of an Abbott Labs drug.

Teva Pharmaceutical Industries said it launched progesterone capsules in the 100-mg and 200-mg strengths, a generic version of Prometrium.

Prometrium is indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogen tablets. The drug also is indicated for use in secondary amenorrhea.

For the 12 months ended Jan. 31, Prometrium had sales of approximately $198 million, according to IMS Health data.

March 2, 2012

Watson has launched an authorized generic drug for treating postmenopausal women, the company said Friday.

PARSIPPANY, N.J. — Watson has launched an authorized generic drug for treating postmenopausal women, the company said Friday.

Watson announced the launch of progesterone capsules in the 100-mg and 200-mg strengths, an authorized generic version of Abbott Labs' Prometrium, under an agreement with Abbott. Abbott will manufacture the drug and supply it to Watson, which will market and distribute it and share profits. Other terms were not disclosed, the companies said.

February 23, 2012

The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics' Korlym (mifepristone) for endogenous Cushing's syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.

February 22, 2012

It seems insulin production and beta cell functioning may persist despite the onset of Type 1 diabetes, according to research conducted at the Massachusetts General Hospital and published in the March issue of Diabetes Care.

BOSTON — It seems insulin production and beta cell functioning may persist despite the onset of Type 1 diabetes, according to research conducted at the Massachusetts General Hospital and published in the March issue of Diabetes Care.

February 1, 2012

Self-monitoring blood glucose levels in Type 2 diabetics not on an insulin regimen may contribute little to managing the disease, according to an analysis published online last month by The Cochran Library.

CHICHESTER, England — Self-monitoring blood glucose levels in Type 2 diabetics not on an insulin regimen may contribute little to managing the disease, according to an analysis published online last month by The Cochran Library.

February 1, 2012

A new study published in the American Journal of Gastroenterology examined the possible link between pancreatic cancer and drugs designed to treat diabetes, and found the association to be unclear.

NEW YORK — A new study published in the American Journal of Gastroenterology examined the possible link between pancreatic cancer and drugs designed to treat diabetes, and found the association to be unclear.

Researchers conducted a case-control study based on the British-based General Practice Research Database, which included drug prescriptions, diagnostics, hospitalizations and fatality information. The researchers also took into consideration such factors as body mass index, smoking, alcohol consumption and diabetes duration.

January 30, 2012

Iceland-based drug maker Actavis and Poland-based Bioton have formed a partnership that they said would "shake up" the diabetes market.

WARSAW, Poland — Iceland-based drug maker Actavis and Poland-based Bioton have formed a partnership that they said would "shake up" the diabetes market.

Actavis and Bioton announced the signing of a $73.3 million deal to develop, manufacture and commercialize insulin products, including insulin analogues. Of that, Actavis will pay $29.4 million to Bioton when the deal is signed, while the rest will consist of milestone payments.

January 25, 2012

CinSulin, based in Issaquah, Wash., is in the process of launching a cinnamon water extract to help maintain healthy blood-glucose levels for patients with prediabetes or Type 2 diabetes.

ATLANTA — CinSulin, based in Issaquah, Wash., is in the process of launching a cinnamon water extract to help maintain healthy blood-glucose levels for patients with prediabetes or Type 2 diabetes.

The extract contains a concentrated cinnamon extract through a proprietary process that separates the water-soluble components from unwanted fat-soluble components. The result is an extract that is on average 10 times stronger than the average cinnamon supplement, the company stated.

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 16, 2012

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

SILVER SPRING, Md. — The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

But the agency said it knew of two undisclosed hospitals that it said had reused the cartridge components of insulin pens in administering insulin to more than 2,000 patients, though the hospitals reportedly changed the pens themselves.

January 9, 2012

Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

ALLEGAN, Mich. — Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

Perrigo announced the $36 million acquisition of Alpharetta, Ga.-based CanAm Care, whose assets include Dex4 hypoglycemia products, insulin delivery syringes and pen needles, lancing, wound care and compression stockings.

December 8, 2011

A combination of two insulins made by Novo Nordisk reduced abnormally low blood sugar in diabetes patients, according to study results presented at a medical conference.

DUBAI, United Arab Emirates — A combination of two insulins made by Novo Nordisk reduced abnormally low blood sugar in diabetes patients, according to study results presented at a medical conference.

December 1, 2011

In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

SILVER SPRING, Md. — In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

December 1, 2011

Many people with Type 2 diabetes have managed to integrate the treatments they must take into their daily lives, but many do not reach their blood-glucose goals after they start insulin therapy.

INDIANAPOLIS — Many people with Type 2 diabetes have managed to integrate the treatments they must take into their daily lives, but many do not reach their blood-glucose goals after they start insulin therapy.

Drug maker Eli Lilly is partnering with Brigham and Women's Hospital in Boston in a study that started in July and has enrolled 4,500 people in 17 countries to find out why many people with the disease resist a progression of insulin therapy.

December 1, 2011

A new study conducted by researchers at Yeshiva University's Albert Einstein College of Medicine found that high blood-sugar levels may be associated with an increased risk of colorectal cancer.

BRONX, N.Y. — A new study conducted by researchers at Yeshiva University's Albert Einstein College of Medicine found that high blood-sugar levels may be associated with an increased risk of colorectal cancer.

Researchers examined the fasting blood sugar and insulin levels of nearly 5,000 postmenopausal women — all of whom were enrolled in the National Institutes of Health's landmark Women's Health Initiative study — several times over a 12-year period.

November 16, 2011

The Food and Drug Administration has approved a new insulin-delivery system for Type 1 diabetes made by Tandem Diabetes Care, the company said Wednesday.

SAN DIEGO — The Food and Drug Administration has approved a new insulin-delivery system for Type 1 diabetes made by Tandem Diabetes Care, the company said Wednesday.

Tandem announced the approval of the T:slim, a pump that the company said is the first to have a color touch screen and is the smallest insulin pump system available, in addition to being one of the first to be approved under the FDA's new Infusion Pump Improvement initiative.

November 3, 2011

Novo Nordisk has donated $50,000 to an organization that raises awareness about diabetes and connects people living with it, the Danish drug maker said.

PRINCETON, N.J. — Novo Nordisk has donated $50,000 to an organization that raises awareness about diabetes and connects people living with it, the Danish drug maker said.

The company said the donation, to the Diabetes Hands Foundation, was meant to recognize the Drive the Switch program, which it said had motivated more than 10,000 people to pledge to talk to loved ones and their doctors about insulin options.

November 2, 2011

Drug maker Perrigo has filed for regulatory approval of a generic topical drug for treating testosterone deficiency, prompting a patent infringement suit from the branded version's manufacturer.

ALLEGAN, Mich. — Drug maker Perrigo has filed for regulatory approval of a generic topical drug for treating testosterone deficiency, prompting a patent infringement suit from the branded version's manufacturer.

October 21, 2011

The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of its Androderm (testosterone) transdermal system in the 2-mg and 4-mg formulation. The company said the new smaller size and lower-dose patch would provide "highly effective" testosterone administration with a 20% reduction in the active ingredient from the original strength. Watson plans to launch the new patch next month.