Content about Recombinant proteins

April 3, 2014

MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes.

VALENCIA, Calif. — MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes. 

February 28, 2014

Pharma Supply earlier this week launched NeedleBay, a safe and easy method of organizing and dispensing insulin pen needles and medication.

WEST PALM BEACH, Fla. — Pharma Supply earlier this week launched NeedleBay, a safe and easy method of organizing and dispensing insulin pen needles and medication.

NeedleBay provides a highly visible, unique and simple “proof of use” reminder, which eliminates the risk of missed, or excess injections and associated medications. NeedleBay has been specially designed in consultation with healthcare professionals and those with diabetes, to enable the user to deploy disposable pen needles safely and to avoid the risk of needle pick injuries.

January 21, 2014

Novo Nordisk has launched a new insulin pen designed for children with diabetes.

NEW YORK — Novo Nordisk has launched a new insulin pen designed for children with diabetes.

The new NovoPen Echo is the first and only prefilled pen device in the United States that allows for half-unit dosing in combination with a memory function, the company said.

November 1, 2013

The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

PLAINSBORO, N.J. — The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

Novo Nordisk announced the FDA approval of Novolog FlexTouch (insulin aspart [rDNA origin]) and Levemir FlexTouch (insulin detemir [rDNA origin]).

October 17, 2013

The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

BAGSVÆRD, Denmark — The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

Novo Nordisk announced the approval of Novoeight (turoctocog alfa), a recombinant coagulation factor VIII, for adults and children with hemophilia, a disease caused by factor VIII deficiency that results in uncontrollable bleeding.

August 21, 2013

The Food and Drug Administration has given the green light to an insulin pen made by Novo Nordisk for half-unit dosing, the drug maker said Wednesday.

PLAINSBORO, N.J. — The Food and Drug Administration has given the green light to an insulin pen made by Novo Nordisk for half-unit dosing, the drug maker said Wednesday.

April 5, 2013

Novo Nordisk has launched a diabetes awareness sweepstakes in which the winners get a free trip to the 2013 IndyCar finale, the Danish drug maker said.

BIRMINGHAM, Ala. — Novo Nordisk has launched a diabetes awareness sweepstakes in which the winners get a free trip to the 2013 IndyCar finale, the Danish drug maker said Friday.

The company announced that it had hired IZOD IndyCar Series Charlie Kimball as spokesman for its Race with Insulin contest. Kimball, the first licensed driver with diabetes to race at the highest level of the series, was diagnosed with the disease during a routine doctor visit in 2007 while racing in Europe and is a user of Novo Nordisk's NovoLog (insulin aspart [rDNA origin]).

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.

November 28, 2012

Novo Nordisk has launched a mobile app for hemophilia patients, the drug maker said.

PRINCETON, N.J. — Novo Nordisk has launched a mobile app for hemophilia patients, the drug maker said.

HemaGo — available for iPhone, iPad and Android devices — is designed to track hemophilia treatment, bleeding episodes and life events, helping people with the condition and their caregivers monitor the details of treatment, including medications, dosing, bleeding information and the disease's effects on life events.

November 9, 2012

A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.

BAGSVÆRD, Denmark — A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.

Novo Nordisk said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had voted 8-to-4 in favor of approval for insulin degludec and a combination treatment containing insulin degludec and insulin aspart.

June 12, 2012

One-quarter of Type 2 diabetes patients do not take basal insulin as prescribed, while more than one-third suffer from hypoglycemia, according to a global survey funded by Novo Nordisk.

PHILADELPHIA — One-quarter of Type 2 diabetes patients do not take basal insulin as prescribed, while more than one-third suffer from hypoglycemia, according to a global survey funded by Novo Nordisk.

June 11, 2012

An investigational insulin being developed by Novo Nordisk significantly reduced the rate of hypoglycemia at night in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented at the 72nd Scientific Sessions of the American Diabetes Association.

PHILADELPHIA — An investigational insulin being developed by Novo Nordisk significantly reduced the rate of hypoglycemia at night in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented at the 72nd Scientific Sessions of the American Diabetes Association.

May 22, 2012

Medical supply manufacturer BD has released a syringe with a shorter needle designed to reduce discomfort in patients with diabetes who must inject insulin, the company said Tuesday.

FRANKLIN LAKES, N.J. — Medical supply manufacturer BD has released a syringe with a shorter needle designed to reduce discomfort in patients with diabetes who must inject insulin, the company said Tuesday.

BD announced the introduction of the ultra-fine 6mm needle, saying more than 80% of patients expressed a preference for it in trials, and a recent article published by the American Association of Diabetes Educators recognized the safety and efficacy of shorter needles.

The needle is designed to deliver insulin subcutaneously in adults and children.

April 2, 2012

A diabetes treatment made by Novo Nordisk is safe for pregnant women, according to a recent decision by the Food and Drug Administration.

NEW YORK — A diabetes treatment made by Novo Nordisk is safe for pregnant women, according to a recent decision by the Food and Drug Administration.

Novo Nordisk said Monday the FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses. The agency's decision was based on results of a clinical trial involving 310 women that compared Levemir to another insulin product.

The insulin is used to treat Type 1 and Type 2 diabetes.

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.

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 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.

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.

October 20, 2011

A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

INDIANAPOLIS — A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

Lilly and Amylin said Byetta (eventide) won approval from the FDA as an add-on therapy for patients with Type 2 diabetes taking Sanofi's Lantus (insulin glargine [rDNA origin]) who have not achieved adequate blood sugar control on Lantus alone.

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 28, 2011

A new study indicated that two insulin products made by French drug maker Sanofi lower blood-glucose levels to a greater extent than premixed insulin, and with improvements in quality of life and less hypoglycemia.

PARIS — A new study indicated that two insulin products made by French drug maker Sanofi lower blood-glucose levels to a greater extent than premixed insulin, and with improvements in quality of life and less hypoglycemia.

Sanofi announced results of the 60-week study, which compared regimens, including Lantus (insulin glargine [rDNA origin]) and Apidra (insulin glulisine [rDNA origin]).

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.