Sep 28, 2017

FDA slows down diabetes "unicorn"

Dan Primack, author of Pro Rata

The ITCA 650 device. Photo: Intarcia Therapeutics

The FDA yesterday erected a new speed-bump for Intarcia Therapeutics, the Boston biotech "unicorn" that has developed a matchstick-sized implantable device for Type II diabetes treatment.

What happened: The FDA sent a Complete Response Letter that Intarcia says relates to aspects of its device manufacturing process (the letter itself was not publicly released). That means commercialization in the U.S. will be delayed from Q4 of this year to the second half of 2018. Intarcia says the CRL should not necessitate any additional clinical trials.

Why it matters, beyond for Type II diabetes patients: Intarcia CEO Kurt Graves has been the rare VC-backed biotech CEO who has insisted on commercializing before IPO, and yesterday told Axios that there is no change to that strategy. He added that the company has now raised over $615 million for its Series EE funding, which held a $215 million first close last fall at a $3.5 billion pre-money valuation. Most of the additional cash has come from sovereign wealth funds.

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In photos: George Floyd's North Carolina memorial service

The remains of George Floyd are brought into Cape Fear Conference B Church. Photo: Ed Clemente/POOL/AFP via Getty Images

Hundreds gathered in Raeford, North Carolina to honor George Floyd, whose death in Minneapolis nearly two weeks ago has sparked nationwide protests against police brutality.

The state of play: This is the second memorial for Floyd. A number of his family members remain in Raeford, including his sister. He was born in Fayetteville, North Carolina, The News and Observer reports.

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Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 2 p.m. ET: 6,800,604 — Total deaths: 396,591 — Total recoveries — 2,785,268Map.
  2. U.S.: Total confirmed cases as of 2 p.m. ET: 1,908,235 — Total deaths: 109,443 — Total recoveries: 491,706 — Total tested: 19,231,444Map.
  3. Public health: Some people are drinking and inhaling cleaning products in attempt to fight coronavirus Fauci: "Very concerned" about spread of virus amid George Floyd protests — Cities offer free testing for protesters.
  4. Tech: The pandemic is accelerating next-generation disease diagnostics — Robotics looks to copy software-as-a-service model as use of robots accelerates.
  5. Business: Sports, film production in California to resume June 12 after 3-month hiatus
  6. Education: Students and teachers flunked remote learning.

George Floyd updates

A protester holds a placard reading "Covid kills People, Racism kills Communities" as they attend a demonstration in Manchester, northern England, on June 6, to show solidarity with the Black Lives Matter movement in the wake of the killing of George Floyd. Photo: Paul Ellis/Contributor.

Thousands are gathering for a day of protests in Washington, D.C., almost two weeks after George Floyd's killing. Protesters in Australia and Europe staged anti-racism demonstrations on Saturday as well.

What's happening: A memorial service for Floyd is taking place in Raeford, North Carolina — near where he was born. Gov. Roy Cooper ordered all flags to fly at half-staff to honor Floyd until sunset. Thousands of demonstrators have gathered in Philadelphia and Chicago.