Jun

26

ZURICH, June 25 (Reuters) - Japanese regulators approved a human growth hormone from Novartis AG, the first green light in Japan for a biosimilar or generic version of a biotech drug, the Swiss drugmaker said on Thursday

Biosimilars are viewed as a promising new market, given the pent-up demand for cheaper versions of extremely expensive biotech drugs, some of which are coming to the end of their patent life.

Somatropin, made by Novartis’ generics unit Sandoz, is for treatment of growth hormone deficiency in children and growth disturbance associated with Turner’s syndrome or chronic renal insufficiency, the group said.

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May

13

(PhysOrg.com) — A new method developed by Cornell biological engineers offers an efficient way to make proteins for use in medicine or industry without the use of live cells. The proteins made in this way include many that cannot be produced by current biotechnology.

Current methods employ vats of genetically modified bacteria or mammalian cells that churn out proteins for such pharmaceuticals as insulin or human growth hormone (hgh). But there are many proteins that bacteria or cells cannot tolerate. Anti-microbials, for example, are meant to kill bacteria and so would kill the host. And many key proteins that are important in regulating the normal life of a cell would also kill the host if overproduced inside a cell.

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Mar

11

March 10 (Bloomberg) — Momenta Pharmaceuticals Inc. may become the first drugmaker to win U.S. clearance to sell generic versions of a biotechnology medicine, getting a head start on President Barack Obama’s plan to trim health-care costs by making such copycats commonplace.

Brand-name biotech treatments, which can cost individual consumers or their health plans as much as $200,000 a year, are made from living cells, unlike pharmaceutical medicines that are chemical-based. Generic-drug companies can’t sell copies of brand-name biotechnology drugs because the 1984 U.S. law allowing versions of conventional pills doesn’t provide a system to measure safety and approve so-called biogenerics.

Not all drugs made from living cells are considered by the FDA through the agency’s biologics license application process. For a variety of reasons, some categories of treatments made using living cells, including insulin, human growth hormone (hgh) and heparins, were approved under the process for conventional medications.

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Jun

17

 Breaking HGH news:

 

 Researchers at Ohio University have identified several proteins in mice that might act as biomarkers for growth hormone (hgh).

Led by John Kopchick and Juan Ding, the research may prove to be the first step towards finding reliable way to detect recombinant human growth hormone (rhGH), which some athletes and teenagers use illegally to boost muscle and reduce fat.

The researches found four proteins that significantly decreased or increased in the blood after exposure to bovine growth hormone, which is similar to human growth hormone (hgh).

In the study, the researchers injected six 6-month-old male mice with growth hormone for seven days and examined blood samples from the mice and compared the results to six control animals. They also scanned hundreds of plasma proteins and found four – apoA1, transthyretin, clusterin and albumin – that showed a strong reaction to growth hormone.

 

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