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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.

Go deeper

3 hours ago - Politics & Policy

Scoop: Kaine, Collins pitch Senate colleagues on censuring Trump

Sen. Tim Kaine speaks with Sen. Susan Collins. Photo: Andrew Harnik/AP via Getty Images

Sens. Tim Kaine and Susan Collins are privately pitching their colleagues on a bipartisan resolution censuring former President Trump, three sources familiar with the discussions tell Axios.

Why it matters: Senators are looking for a way to condemn Trump on the record as it becomes increasingly unlikely Democrats will obtain the 17 Republican votes needed to gain a conviction in his second impeachment.

3 hours ago - Politics & Policy

Scoop: Anthony Coley to lead Justice Department public affairs

Photo: Xinhua/Ting Shen via Getty Images

Judge Merrick Garland, President Biden’s nominee for attorney general, has tapped Anthony Coley, an Obama-era Treasury Department official, to serve as a senior adviser and to lead public affairs at the Department of Justice, according to people familiar with the matter.

Why it matters: As the public face of the DOJ, Coley will help explain — and defend — the department's actions, from sensitive cases to prosecutorial decisions, including the investigation into Hunter Biden.

AP: Justice Dept. rescinds "zero tolerance" policy

A young girl waves to onlookers through the fence at the U.S.-Mexico border wall in San Ysidro, California, in Nov. 2018. Photo: Sandy Huffaker/AFP via Getty Images

President Biden's acting Attorney General Monty Wilkinson issued a memo on Tuesday to revoke the Trump administration's "zero tolerance" immigration policy, which separated thousands of migrant children from their families at the U.S.-Mexico border, AP first reported.

Driving the news: A recent report by Justice Department Inspector General Michael Horowitz emphasized the internal chaos at the agency over the implementation of the policy, which resulted in 545 parents separated from their children as of October 2020.