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3 things the FDA should consider in designing a pathway for biosimilars (Best of MedCitizens)

Every week MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com. Now here’s the best of what YOU had to say.

Every week MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

FDA should require clinical trials and unique names for all biosimilars. “The Supreme Court decision gives the FDA the opportunity to move forward in the development and approval of biosimilars. In the coming months and years there is tremendous hope for more patients to benefit from these novel medicines, as long as patients and doctors can be certain they are safe and effective.”

Silk stabilizer may eliminate need to refrigerate vaccines and antibiotics. “Researchers funded by the National Institutes of Health have developed a new silk-based stabilizer that, in the laboratory, kept some vaccines and antibiotics stable up to temperatures of 140 degrees Fahrenheit. This provides a new avenue toward eliminating the need to keep some vaccines and antibiotics refrigerated, which could save billions of dollars every year and increase accessibility to third world populations.”

Courts affirm that a hospital owns a doc’s invention. But can physicians change that? “According to the Boston Globe, a state superior court judge has thrown out a complaint lodged by a Massachusetts General Hospital (MGH) urologist who challenged the hospital’s policy denying him ownership of inventions he discovered on his own time at home. The judge wrote that Dr. Joseph Grocela reaps benefits from the MGH hospital and in return he has agreed to contribute to objectives of the urology department, which includes patenting medical ideas. The judge specifically stated, ‘This kind of quid pro quo underlies almost every professional association.'”

High noon for Marqibo: What may happen with Talon’s chemotherapy drug. “Talon Therapeutics Inc, largely backed by venture capital, is banking on U.S. regulatory approval for its version of a nearly 50-year-old chemotherapy drug, which it expects will open the door to new licensing deals.”

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Another amazing example of the potential of 3D printing in healthcare (video).  “Two-year-old Emma was born with a rare disease called arthrogryposis that makes it so she can’t raise her arms without assistance. Through the use of 3D printing, Delaware hospital created a mobile plastic exoskeleton that now allows Emma to use her arms for many things. 3D printing ensures that a new exoskeleton can be created if Emma breaks or outgrows it. Emma is now on her second 3D-printed jacket and calls the device her ‘magic arms.'”

[Photo from renjith krishnan]

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