President Biden’s nominee to be the next FDA commissioner officially has his Senate confirmation hearing set for next Tuesday. Rob Califf, who’s prepping for his second run as FDA commish, will be peppered with questions by senators ahead of an up or down vote that will likely go Califf’s way.

At least four Democrats, including Bernie Sanders and West Virginia’s Joe Manchin, have already said they won’t vote for Califf, as they did during Califf’s first confirmation (89-4 was the final vote on that one). While Califf’s industry ties and views on the pandemic will likely be the focus of the hearing, all eyes will be on the Republicans (given the tight R-D split in the Senate), and whether they’re willing to back a Biden nominee.

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It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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