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The Readout Damian Garde

Officially, the HPV vaccine doesn't prevent head and neck cancer. But it probably does

The Merck vaccine that prevents cervical cancer, Gardasil, has been a roaring public health success; researchers believe the disease could be eradicated in some countries within 20 years.

A new study published in JAMA shows that the vaccine also seems to prevent infections of the human papilloma virus, which causes cervical cancer, in the throat. That's important because there are 13,500 cases annually of cancer of the throat and mouth caused by HPV.

One of the study's authors, Maura Gillison, was among the first to notice that cases of HPV-caused head and neck cancer were rising, and says she tried to get Merck to run studies of oral transmission of the virus. Experts say the new data indicate that giving the vaccine more broadly could prevent cases of head and neck cancer in the future. But, STAT's Matt Herper tells us, there's a lot standing in the way of that happening.

Read more.

At last, lots of liquid biopsy data exists

After years of skepticism, liquid biopsy companies are creating a wave of actual, published data. 

Personal Genome Diagnostics, a Maryland-based company, is the latest to publish its own. The company has a new paper out in Clinical Cancer Research showing that its blood test can identify a key characteristic of tumors that’s normally only discernible with a biopsy. 

One of the two biomarkers the test tries to detect is “microsatellite instability,” or MSI-High — which is used to predict whether a person’s tumor could respond to immunotherapies like Keytruda. Guardant Health published its own data on a similar test last month; Grail presented its data on a blood test meant for screening healthy people in May.

Personal Genome, which has received funding from New Enterprise Associates and Bristol-Myers Squibb, has some familiar faces among its founding advisors. Three of the scientists behind Thrive Earlier Detection Corp, another venture-backed liquid biopsy company, also serve on PGDx’s board

The FDA would like to hear your thoughts on poop transplants

The Food and Drug Administration will be reexamining its approach for fecal microbiome transplants — again. The agency said  yesterday that it will hold its second public workshop about the transplants. 

The announcement comes less than three months after the FDA announced someone died due to drug-resistant bacteria thought to have been included in a fecal transplant. At the time, the agency also recommended new screening procedures for would-be donors.

Technically, just one indication, recurrent C. difficile infection, will be discussed at the workshop, which is happening on Nov. 4. But among the questions the FDA hopes to answer is how FMTs’ availability may affect the development of drugs targeting the same infection — an issue that the field has been considering for a long time.

If you’re planning to go to the meeting, STAT’s Kate Sheridan would love to know.

About drug makers', um, reputation

The biotech industry has found itself smack in the middle of a florid debate on drug pricing policy — and one trade association’s leaders aren’t happy with their reputation. 

“We’re the worst perceived entity [in America], and that’s ridiculous,” said Jeremy Levin, who recently began his term as chair of the Biotechnology Innovation Organization’s board. 

Levin, a social liberal but fiscal conservative, has previously suggested that federal legislation targeting out-of-pocket costs might be one way to fix the drug pricing problem. But during a Monday meeting, the industry group’s leaders made it clear they hadn’t seen many proposals they liked.

STAT’s Nicholas Florko listened to what BIO had to say.

More reads

  • Apple is doubling down on health tech (STAT)
  • AVEO Oncology has fresh data on an old, rejected drug — and it’s looking better this time (Boston Business Journal)
  • What is the “U.S. Bioeconomy,” federal government asks (Federal Register)

Thanks for reading! While Damian’s on vacation, STAT’s Meghana Keshavan will be back with more tomorrow.

Wednesday, September 11, 2019


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