As part of an effort to shore up public confidence in the FDA’s emergency use authorization processes, the agency on Monday released additional scientific review documents on Eli Lilly’s and Regeneron’s monoclonal antibodies, which were authorized to treat mild to moderate Covid-19.

The newly released letters of authorization, which were updated in late February, show that the agency is increasingly concerned about the ability for certain variants, like B.1.351, the variant first identified in South Africa, to evade the antibody treatments.

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Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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Genentech has long been a headhunter’s paradise with biotechs shopping for top execs with premium résumés, so it’s not unusual to see some long-time employees jumping ship. Now, one of the commercial leads on the company’s oncology portfolio is leaving after a 20-year stint to try his hand at a tiny oncolytic virus biotech.

Sushil Patel, Genentech’s former global oncology franchise head for lung and skin cancer and rare/agnostic tumor types, will leave his post at the world’s first biotech to head commercial at a much smaller operation in Replimune, which is using oncolytic viruses to hunt solid tumors.

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