The Readout Damian Garde

Guardant's liquid biopsy works in Keytruda's favor

Cancer diagnostics company Guardant Health has incorporated a pan-cancer microsatellite instability test into its liquid biopsy product, Guardant360 — and, according to a 1,000-patient study, it’s proving to be accurate, the company said this morning.

The test could be particularly important for Merck: So-called MSI status can flag whether a patient would benefit from taking pembrolizumab, or Keytruda. 

To date, it’s been tricky to determine whether a particular cancer might have microsatellite instability. The process currently requires a traditional biopsy, which isn’t always possible for cancer patients. But considering the fact that pembrolizumab is now an approved option for all cancers that are linked to microsatellite instability, a simple blood test could improve patients' odds of receiving the drug when they need it. 

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George Church is sorry about the Epstein matter

George Church, one of Harvard’s top biologists, is deeply contrite about  holding discussions with financier — and accused sex trafficker — Jeffrey Epstein. Church, who communicated with Epstein even after the latter pleaded guilty in 2008 for soliciting a minor for prostitution, claimed it was a case of “nerd tunnel vision,” he told STAT’s Sharon Begley

Epstein, who was indicted last month, had multiple meetings with various biologists, physicists, mathematicians, and other researchers at Harvard and elsewhere, as he sought to bolster his tarnished reputation in the financial world — claiming on his website that he had “the privilege of sponsoring many prominent scientists.” 

Church said his fellow scientists may have been somewhat naive to Epstein’s transgressions, and basked in his flattery.

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Allogene snags a competitor — and a friend

Allogene Therapeutics, the allogeneic T-cell therapy company launched by billionaire urologist and Kite Pharma founder Arie Belldegrun, is unveiling a high-profile recruit today: It’s bringing over Dr. Rafael Amado, president of R&D at Adaptimmune, a competitor.

Adaptimmune is also in the business of engineering immune cells to attack cancer, and has been working toward an allogeneic T-cell therapy to treat cancer. It’s a nice little reunion: Amado worked once with Belldegrun at UCLA, and also with David Chang, Allogene’s CEO, at Amgen.

A sad day for compounding pharmacies

It’s a victory for drug companies and a blow to compounding pharmacies: A federal judge has ruled that the FDA was correct to block a compounder from using an ingredient that is necessary to make the branded drug, Vasostrict. 

The FDA had determined that a compounded version of vasopressin (which is used to increase blood pressure in patients with vasodilatory shock) wasn’t clinically necessary — and said that only the drug maker, Endo International, would be allowed to make and sell Vasostrict. The judgment came after Endo sued the FDA for allowing bulk compounding of hundreds of drugs, STAT’s Ed Silverman writes.

Read more.

More reads

  • Colombian regulator fines Pfizer for inflating prices on several medicines. (STAT)
  • FDA approves Daiichi Sankyo's treatment for rare joint tumor. (Reuters)
  • Cancer patients are being denied drugs, even with doctor prescriptions and good insurance. (Fresno Bee)

Thanks for reading! More tomorrow,


Monday, August 5, 2019


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