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FDA Guidance on Biosimilars Paves Way for New, Multi-billion Dollar Market


IP Blog | Dave Melin | May 18, 2014

BioBlogWeeklyThis week in healthcare, the FDA releases a guide on biosimilars and at Mayo Clinic measles put cancer into “complete remission”.

FDA: Guidance for Industry [PDF]

This week the FDA released a long-awaited draft guidance sheds light on the measures it will use to evaluate “demonstration of biosimilarity to a reference product.” Read the full draft linked above, or you can read our summary about the impact of this guidance.

Mayo Clinic trial: Massive blast of measles vaccine wipes out cancer

In a historic moment for experimental cancer treatment, a woman with tumors in her bone marrow participated in a Mayo Clinic trial where she was injected with a massive dose of a measles vaccine. Her cancer “went into complete remission and was undetectable in Erholtz’s body after just one dose of the measles vaccine, which has an uncanny affinity for certain kinds of tumors.”

Massachusetts Starts Over on Health Websites After Troubles

This month Massachusetts announced that it would abandon their existing state exchange. To help fix their enrollment process, they will both purchase new software to build a new system and prepare to join the federal exchange in November in case their software is not functioning in time.

Cancer Treatment as Comic Book

Cartoonist Matt Freedman had a unique and creative response to his treatment for tongue and lymph node tumors: he wrote a graphic novel. About his sometime-hilarious, sometimes-bleak chronicle, Relatively Indolent But Relentless: A Cancer Treatment Journal, Freedman said, “I’m amazed at how desperate I felt and all the more grateful I kept the journal.”

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