Content about Peptide hormones

April 9, 2013

The developer of an amino acid compound is issuing a new license for the product.

NEW YORK — The developer of an amino acid compound is issuing a new license for the product.

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]).

March 25, 2013

SanMedica International introduced its SeroVital-HGH, a new oral human-growth hormone booster formulated with women in mind, at the Academy of Women's Health's Annual Congress.

WASHINGTON —  SanMedica International on Friday introduced its SeroVital-HGH, a new oral human-growth hormone booster formulated with women in mind, at the Academy of Women's Health's Annual Congress here. 

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.

December 27, 2012

Demand for SeroVital-hgh — a proprietary amino acid compound developed by Sierra Research Labs — has spiked in the past month. To help meet demand, the company on Dec. 21 announced distribution expansion through GNC.

NEW YORK — Demand for SeroVital-hgh — a proprietary amino acid compound developed by Sierra Research Labs — has spiked in the past month, in part due to recent exposure on news channels like CNN and on news programs like "The Today Show," the company announced last week. To help meet demand, the company on Dec. 21 announced distribution expansion through GNC. 

December 6, 2012

The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

DANBURY, Conn. — The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

Biodel announced that it had received orphan drug designation for glucagon to prevent hypoglycemia, or abnormally low blood sugar, in patients with CHI.

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.

September 21, 2012

The National Advertising Division on Thursday recommended that Church & Dwight discontinue its claim that the company’s First Response digital ovulation test is the “first and only test to predict ovulation based on your unique LH hormone level.”

NEW YORK — The National Advertising Division on Thursday recommended that Church & Dwight discontinue its claim that the company’s First Response digital ovulation test is the “first and only test to predict ovulation based on your unique LH hormone level.”

The claim, which appeared on product packaging and on the company’s website, was challenged by SPD Swiss Precision Diagnostics, the maker of the Clearblue DOT, a competing digital ovulation test product.

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

When one of Amylin Pharmaceuticals' diabetes drugs is used with mealtime insulin, both Type 1 and Type 2 diabetes patients maintain blood sugar in the normal glucose range on a daily basis, according to two analyses presented at the 72nd Scientific Sessions of the American Diabetes Association.

PHILADELPHIA — When one of Amylin Pharmaceuticals' diabetes drugs is used with mealtime insulin, both Type 1 and Type 2 diabetes patients maintain blood sugar in the normal glucose range on a daily basis, according to two analyses presented at the 72nd Scientific Sessions of the American Diabetes Association.

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.

April 3, 2012

Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.

SAN DIEGO — Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.

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.

March 8, 2012

The market for drugs to treat diabetes — especially Type 2 diabetes — has shown quite a bit of activity lately.

The market for drugs to treat diabetes — especially Type 2 diabetes — has shown quite a bit of activity lately. At the end of January, the Food and Drug Administration approved Bydureon (exenatide), a once-weekly version of the drug Byetta, which was originally developed by Alkermes and subsequently developed further under an alliance between Amylin Pharmaceuticals and Eli Lilly that the two companies formed in 2002. In November 2011, however, Amylin and Lilly terminated their alliance in the wake of an announced diabetes drug partnership between Lilly and Boehringer Ingelheim.

March 7, 2012

A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

INDIANAPOLIS — A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The Food and Drug Administration approved the drug on Jan. 30.

February 3, 2012

Endocrinologists would prescribe a newly approved weekly treatment for Type 2 diabetes to one-fifth of their patients, a new survey showed.

BURLINGTON, Mass. — Endocrinologists would prescribe a newly approved weekly treatment for Type 2 diabetes to one-fifth of their patients, a new survey showed.

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 30, 2012

The Food and Drug Administration has approved a long-acting injected diabetes drug made by Amylin Pharmaceuticals and Alkermes, the two companies said.

SAN DIEGO — The Food and Drug Administration has approved a long-acting injected diabetes drug made by Amylin Pharmaceuticals and Alkermes, the two companies said.

The FDA approved Bydureon (exenatide), which the companies called the first once-weekly treatment for Type 2 diabetes. The drug will become available in February.

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.

December 6, 2011

The Food and Drug Administration and the Federal Trade Commission on Tuesday issued seven warning letters to companies marketing over-the counter human chorionic gonadotropin products that are labeled as "homeopathic" for weight loss.

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission on Tuesday issued seven warning letters to companies marketing over-the counter human chorionic gonadotropin products that are labeled as "homeopathic" for weight loss. The letters warn the companies that they are violating federal law by selling drugs that have not been approved and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

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.