Jan

6

Colorado Springs pharmacy owner Thomas Bader knew he was breaking the law by importing and distributing human growth hormones from China, prosecutors charged Tuesday.

Assistant U.S. Attorney Jaime Peña told a federal jury that Bader and a sales representative had an attitude as they pursued their illicit business.

“They told us we couldn’t do it so we did it anyway,” Peña said, describing that attitude in opening statements of a trial in which Bader, 67, is accused of conspiracy, smuggling and illegal distribution of the hormones. Prosecutors contend the hormones lacked U.S. Food and Drug Administration approval.

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Dec

7

Big Pharms & HGH

December 7, 2009 | Leave a Comment

Pharmaceutical companies are awakening to the fact that being first in market and first in class is no longer enough. While most agree that the blockbuster approach is all but dead, there is considerable debate about its successor. “Big pharma” continues to invest record amounts in drug discovery research, but what can they learn from specialty pharma, drug delivery devices companies, and even the generics industry? A select group of thought leaders from pharma, biopharma, device manufacturers, payers, providers, and policymakers met recently at an industry forum event sponsored by Cambridge Consultants to address these issues and answer the question: “What will the shape of the drug delivery landscape look like ten years from now and what drivers would create this change?”

    Formulation can help to mitigate systemic impact, and some opportunities are thought to exist where formulation and device development are progressing hand-in-hand. In the case of the Glide Pharma (Oxford, UK) Glide-SDI, solid doses of the drug are injected via a reusable actuator eliminating the use of needles. Where injection delivery is used, optimizing compliance and comfort is the key driver. It is anticipated that micro-electronics will add some significant value to such devices by offering dose reminders, dose recording, and compliance monitoring. An example of this is EasyPod, where a sophisticated device has had a significant impact in the human growth hormone market, improving acceptance, compliance and market share for Merck Serono (Geneva, Switzerland). Incorporating these advanced delivery devices are not without challenge.

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    Formulation can help to mitigate systemic impact, and some opportunities are thought to exist where formulation and device development are progressing hand-in-hand. In the case of the Glide Pharma (Oxford, UK) Glide-SDI, solid doses of the drug are injected via a reusable actuator eliminating the use of needles. Where injection delivery is used, optimizing compliance and comfort is the key driver. It is anticipated that micro-electronics will add some significant value to such devices by offering dose reminders, dose recording, and compliance monitoring. An example of this is EasyPod, where a sophisticated device has had a significant impact in the human growth hormone market, improving acceptance, compliance and market share for Merck Serono (Geneva, Switzerland). Incorporating these advanced delivery devices are not without challenge.

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Oct

8

From the United States Attorney’s Office, District of New Hampshire
On July 27, 2009, Christopher Chase, of Lynn, Massachusetts, was sentenced to three and a half years imprisonment and three years of supervised release for his involvement in an Internet prescription drug scheme that distributed anabolic steroids, human growth hormone (HGH), insulin-like growth factor (IGF-1), and clenbuterol throughout the United States. A two-count indictment charged Chase and two codefendants with conspiracy and money laundering.

According to the indictment, Chase and his team illegally imported the drugs from overseas, primarily China, marketed them as body-building substances, and sold them without a prescription on various websites. Of course, FDA has not approved anabolic steroids, HGH, or IGF-1 for use in body-building activities, and clenbuterol is not approved for use in humans by FDA. Although some countries have approved it as a prescription-only bronchodilator, clenbuterol is known to be abused by bodybuilders for its weight-loss properties, according the the Department of Justice. The money from the sales of these drugs was sent to various merchant bank accounts that Chase had set up, and then laundered through foreign countries such as China and Moldova.

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Aug

27

NEW YORK — Drugmaker Pfizer Inc. said Tuesday it opened a new biotech facility in Sweden, which will be used to make products including a branded version of human growth hormone (HGH).

Pfizer ( PFE - news - people ) said it invested 150 million Euros ($214.8 million) in the plant in Strangnas. The facility is 6,000 square meters, or about 64,600 square feet. Products made at the plant will include Pfizer’s human growth hormone, or Genotropin, along with the drug Somavert for acromegaly, and drugs based on E. coli and yeast.

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Read the Forbes/HGH article here.

Aug

13

Prolor Biotech obtained a nonexclusive license to The University of Queensland’s (UQ) human growth hormone (HGH) receptor cell line. It will help the company expedite development and manufacturing of its long-acting version of HGH, comments Shai Novik, president of Prolor Biotech.

“Not only can the cell line measure the hormone’s potency, but it can also be used to detect neutralizing antibodies directed against HGH,” Novik points out. The UQ cell line will also result in significant cost savings, provide more reliable and consistent results compared to current techniques, and does not require animals for testing, the company continues.

Current manufacturers of human growth hormone assay for potency by using hypophysectomized rodents. HGH is then administered to the animals and the potency determined by measuring their weight gain and length of femur. This assay is not only extremely expensive but also produces inconsistent results, according to Prolor Biotech.

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Jul

1

The FDA issued approval for Antares Pharma’s (Ewing, New Jersey) needle-free injection device for use with Tev-Tropin brand human growth hormone (hGH) from Teva out of Petach Tikva, Israel. The device will be marketed under the name Tev-Tropin Tjet Injector system.

 Reusable Needle-Free Injectors (Medi-Jector VISION®) deliver precise medication doses through high-speed, pressurized liquid penetration of the skin without a needle. These reusable, variable-dose devices are engineered to last for a minimum of two years and are designed for easy use, facilitating self-injection with a disposable plastic needle-free syringe to assure safety and efficacy. The associated disposable plastic needle-free syringe, offers high precision liquid medication delivery through an opening that is approximately half the diameter of a standard, 30-gauge needle and it is designed to last for approximately one week. Antares has sold the Medi-Jector VISION® for use in more than 30 countries to deliver either insulin or human growth hormone (”hGH”).

                  

 

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Jun

29

BANGALORE, June 29 (Reuters) - Teva Pharmaceutical Industries Ltd  said U.S. health regulators approved its partner Antares Pharma Inc’s needle-free injector device to administer the Israeli company’s human growth hormone.

 

                           “This is an important validation of the Teva partnership, which is  the primary driver of our valuation and excitement about Antares stock,” Ladenburg Thalmann analyst Matthew Kaplan said by phone.

Shares of Antares rose as much as 58 percent to a new year high of $1.14, before paring some gains to trade up at $1.02 in morning trade Monday on the American Stock Exchange.

Teva, the world’s largest generic drug maker, and Antares filed a supplemental new drug application last year to use the needle-free device to administer Tev-Tropin, a human growth hormone.

Human growth hormone is a protein, given by injection, that is commonly used to treat children with growth hormone deficiency.

                          

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Mar

3

Hardcore steroids aren’t the only drugs easily obtainable in the Dominican Republic.

Human growth hormone (hgh) - baseball’s scarlet letter, is available on the black market in Santo Domingo, in Dominican supplement shops and even in the island’s pharmacies, sometimes even without a prescription.

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 Read the entire New York Daily News/HGH article here.

Dec

17

A Greenfield, Ohio man posted bond today in Highland County Court on charges of purchasing and possessing a dangerous drug, human growth hormone (hgh), after an arrest last week that involved both local and federal law enforcement agencies.

Christopher Chad Gose, 33, of Greenfield, was arrested Thursday by Greenfield Police after agents of U.S. Immigration and Customs Enforcement (ICE) notified the department that a package inbound from China was intercepted in the U.S. Postal system on its way to an address in Greenfield. The package was believed to contain humane growth hormone (hgh), a drug known to be abused by some athletes and bodybuilders that is illegal to possess or use without a prescription.

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Dec

10

Pfizer whistleblower and compulsive blogger Peter Rost has tossed his Panama hat into the ring for the post of FDA commissioner in the new Obama administration.

He’s got the “backing” — or at least the paperwork — of Sen. Sherrod Brown and Rep. Jo Ann Emerson. Rost is best-known as the former Pfizer vp who dragged the company’s name through the mud by opposing its position on reimportation and by going public with the news that Pfizer acquired a company it knew was selling human growth hormone(hgh) illegally.

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Read the entire Pfizer/HGH article

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