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.

How about a safe alternative to this injectible HGH drug? We found it! Click here. Read the entire HGH article.

    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.

How about a safe alternative to this injectible HGH drug? We found it! Click here.

Dec

3

One company may lose its HGH patent…

Some of the biggest-selling biologics developed during the boom years in biotech of the 1980’s, including human growth hormone (HGH) and insulin, have lost patent protection in the U.S. in 2007 or will shortly, and they represent a market of $40 billion. This opens up a huge potential market for biosimilars, if regulatory hurdles can be overcome, according to a new report by Kalorama Information, Biogenerics: the World Market for Biosimilars.

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HGH Patent Article

Nov

25

Unilife believes the Unifill(TM) Select is well positioned to cater to the needs of pharmaceutical companies that manufacture vaccines.

Other therapeutic drug sectors where drugs are indicated for administration via IM injection and available in a prefilled syringe format include the anti-viral, human growth hormone (HGH) and anti-inflammatory (arthritis) sectors.

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Read the CNNMoney/HGH article

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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Aug

4

Sometime after her 43rd birthday, Dawn Foley noticed she was beginning to look her age. And she didn’t like it one bit. A former beauty queen turned sales professional in Los Angeles, the blue-eyed brunette is used to turning heads. “I just did not want to look older,” she says.

When Foley approached her ob/gyn seeking hormones, the doctor told her that her levels fell within the normal range of a woman her age and that she didn’t need any more. So Foley instead turned to the world of “age management,” whose practitioners have learned to skirt the law by expanding the definition of growth hormone (HGH) deficiency syndrome to include almost anyone over the age of 30. “That’s one of the first things I learned,” Foley says. “If a regular doctor tests your levels, he’ll say you’re within range even if you’re all the way down at the low end. But [an anti-aging] specialist is going to tell you, ‘You’re within the normal range, but if we bring those levels up, you’ll feel a whole lot better.’”

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Read the entire HGH/MSNBC article.

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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Read the entire HGH article.

Jun

8

A ROGUE Gold Coast doctor who earned millions treating terminally ill cancer patients with unproven ”miracle drugs” has been banned for three years

Michael Tait, 76, was yesterday found guilty of serious unprofessional conduct at a Health Practitioners Tribunal hearing in Brisbane.

The tribunal was told the maverick therapist flouted Queensland Medical Board guidelines by administering the “worthless” anti-cancer drug Ukrain to about 150 terminally ill cancer sufferers.

He was also convicted in a Southport Court in 2006 of selling a human growth hormone (hgh), which he marketed without prescription and at massive profit as a “fountain of youth” drug.

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May

29

MIDDLE-AGED men are increasingly injecting human growth hormones to fight off old age, spending up to $15,000 a year.

Strict government guidelines state human growth hormone (HGH) can only be prescribed to children with growth disorders and adults with severe hormone deficiencies. But Australian anti-ageing clinics prescribe it to mostly male patients as young as 35 who want to look good and stay fit.

Users say human growth hormone (HGH) gives them more energy, but specialists warn it can have serious side effects.

Black market sales are also booming with Australian Customs reporting a four-fold increase in seizures of the prohibited import in the last year.

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Read the entire HGH story here.

May

11

New, improved ISA-TESTâ„¢ GF, from iSatori Technologies, now with clinically tested Somatrinâ„¢, manipulates all three anabolic hormones in men to dramatically raise the body’s natural testosterone, reduce estrogen, and now boost human growth hormone (hgh) factors–for even more muscle mass, more strength, and more sexual drive.

“But while ISA-TEST has remained a very popular product due to its quality of ingredients, strong science, and real-world results, we recently discovered a new ingredient complex, Somatrinâ„¢, that could fill in the final component for total anabolic growth with zero side effects.” Stephen Adele, CEO of iSatori Technologies continues, “In one study, Somatrin was shown to increase growth factors by 140%.

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Read the entire hgh article here.

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