Content about Insulin analog

February 19, 2013

Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.

PITTSBURGH — Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.

Under the deal, Mylan will have the rights to develop and market Biocon's Glargine, Lispro and Aspart, respectively generic versions of Sanofi's Lantus, Eli Lilly's Humalog and Novo Nordisk's NovoLog.

February 11, 2013

The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can't be approved in its current form.

June 21, 2012

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne.

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne. The company expects to launch it in the United States in fourth quarter 2012 under an agreement with Canada-based Cipher Pharmaceuticals.


May 22, 2012

The Food and Drug Administration has approved a treatment for Type 1 diabetes in children ages 2 to 5 years.

PRINCETON, N.J. — The Food and Drug Administration has approved a treatment for Type 1 diabetes in children ages 2 to 5 years.

Drug maker Novo Nordisk announced Tuesday the additional approval of Levemir (insulin detemir [rDNA origin]). The insulin already was approved for Type 1 diabetes in older children and adults and Type 2 diabetes in adults, and the drug maker said the new FDA approval made Levemir the only basal insulin analog for use in the 2 to 5 year age group.

April 9, 2012

The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

PRINCETON, N.J. — The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

March 13, 2012

Pfizer and Indian drug maker Biocon have ended a partnership that the companies started in 2010 to develop biosimilar treatments for diabetes, the companies said.

NEW YORK — Pfizer and Indian drug maker Biocon have ended a partnership that the companies started in 2010 to develop biosimilar treatments for diabetes, the companies said.

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.

October 19, 2011

The Medicines Co. and generic drug maker Teva Pharmaceutical Industries have reached a settlement that will allow Teva to start selling a generic version of one of MDCO’s drugs by the end of the decade.

SUPPLIER NEWS — The Medicines Co. and generic drug maker Teva Pharmaceutical Industries have reached a settlement that will allow Teva to start selling a generic version of one of MDCO’s drugs by the end of the decade. The drug makers announced the settlement in the U.S. District Court for the District of Delaware, whereby Teva can launch a generic version of the injectable anticoagulant drug Angiomax (bivalirudin) in June 2019.


September 30, 2011

Novo Nordisk is seeking approval for two new insulin products, the company said Thursday.

PRINCETON, N.J. — Novo Nordisk is seeking approval for two new insulin products, the company said Thursday.

Novo Nordisk announced that it had filed with the Food and Drug Administration for approval of insulin degludec and a co-formulation of insulin degludec and insulin aspart. The products are insulin analogs developed for the treatment of Type 1 and Type 2 diabetes.

September 13, 2011

An insulin analogue made by Sanofi appears to work better in certain cases than competing treatments at reducing weight gain and controlling blood sugar among patients with Type 2 diabetes.

PARIS — An insulin analogue made by Sanofi appears to work better in certain cases than competing treatments at reducing weight gain and controlling blood sugar among patients with Type 2 diabetes.

July 6, 2011

Patients with Type 1 diabetes using an insulin product made by MannKind expressed a better opinion about insulin therapy than those taking the standard treatment, according to a study presented at the American Diabetes Association’s 71st Scientific Sessions.

SAN DIEGO — Patients with Type 1 diabetes using an insulin product made by MannKind expressed a better opinion about insulin therapy than those taking the standard treatment, according to a study presented at the American Diabetes Association’s 71st Scientific Sessions.

MannKind said that patients taking the investigational inhaled insulin Afrezza (insulin human [rDNA origin]) with basal insulin came to view insulin therapy more positively during the 16-week study than those taking Eli Lilly’s injected Humalog (insulin lispro [rDNA origin]) with basal insulin.

June 27, 2011

An insulin product made by Eli Lilly appears likely to be more cost-effective than long-acting insulin analog, according to a study presented Friday at the American Diabetes Association’s 71st Scientific Sessions in San Diego.

SAN DIEGO — An insulin product made by Eli Lilly appears likely to be more cost-effective than long-acting insulin analog, according to a study presented Friday at the American Diabetes Association’s 71st Scientific Sessions in San Diego.

The company conducted a study comparing the cost-effectiveness of LAIA, insulin lispro mix 75/25 and insulin lispro mix 50/50 in patients with Type 2 diabetes. Lilly sells insulin lispro under the brand name Humalog.

June 9, 2011

Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.

INDIANAPOLIS — Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.

March 24, 2011

Novo Nordisk said new data showed that its basal insulin analog is just as effective as human basal insulin in Type 1 diabetes patients ages 2 to 5 years.

COPENHAGEN — Novo Nordisk said new data showed that its basal insulin analog is just as effective as human basal insulin in Type 1 diabetes patients ages 2 to 5 years.

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.

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.

 

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.

 

August 29, 2010

Novo Nordisk has launched a mobile dosing app for healthcare professionals that prescribe the drug...

PRINCETON, N.J. Novo Nordisk has launched a mobile dosing app for healthcare professionals that prescribe the drug maker's insulin products.

NovoDose, which is available for download on iTunes, allows physicians to select the type of insulin they want to research and review suggested guidelines for dosing, titration and even blood glucose goals for their patients. The app also provides important safety information on the products, and only those who self-identify as healthcare professionals can download the app.

February 10, 2010

A specialty biopharmaceutical company focused on endocrine disorder treatments will present results of two phase...

January 3, 2010

A maker of treatments for endocrine disorders hopes to receive approval from the Food and...