Biden pushes Congress for billions to fund vaccine distribution and tests 

President-elect Biden’s $415 billion proposal to course-correct the country’s Covid-19 response includes quite a lot of money for vaccine distribution and diagnostic tests, STAT's Lev Facher and Rachel Cohrs report. 

Biden, who is set to unveil the details of his vaccination plan on Friday, called the Trump administration’s vaccine rollout “a dismal failure” in an address Thursday evening. He also pledged to meet his goal of administering 100 million vaccine doses in his first 100 days in office. 

Biden’s plan includes $20 billion for vaccine distribution and $50 billion for a dramatic scale-up of the national testing infrastructure, which a transition adviser said could involve a massive investment in rapid antigen tests. The transition also circulated a fact sheet that called for the development and procurement of new Covid-19 therapies, but provided little detail. 

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A very special Readout LOUD: All things JPM

Is Alzheimer’s research stuck in a rut? Can genome editing live up to the hype? And how will we remember Operation Warp Speed? 

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We're devoting this episode to the news coming out of the just-concluded J.P. Morgan Healthcare Conference, the drug industry's largest annual meeting. First, we'll dissect Eli Lilly's surprising data on a new Alzheimer's disease treatment and dig into its implications for the field. Then, we discuss whether there's a bubble inflating in the genome editing world, debate who will run the FDA under a President Biden, and consider the legacy of Moncef Slaoui, the outgoing leader of Operation Warp Speed.

Listen here.

Woodcock eyed for FDA chief

Janet Woodcock, the longtime director of the FDA Center for Drug Evaluation and Research, is being considered by President-elect Biden’s team to serve as commissioner, Bloomberg reports. Woodcock, who has worked 30 years at the agency, is also expected to serve as an interim head of the FDA after Biden’s inauguration. Another top contender for FDA chief is Joshua Sharfstein, who once served as a deputy commissioner at the drug regulating agency. 

Earlier this year, Woodcock left her position at CDER to join a team dedicated to hastening the development of Covid-19 therapies under Operation Warp Speed. She’s been advising FDA Commissioner Stephen Hahn, a Trump appointee. In her place at CDER in the interim is Patrizia Cavazzoni, a quiet problem-solver with both expertise and a little controversy, as my colleague Nicholas Florko reported back in June. 

Aurinia’s kidney drug on the cusp of FDA approval

Next week, the Food and Drug Administration is expected to approve a new medicine from Aurinia Pharmaceuticals that will be used to treat patients with lupus nephritis, a serious autoimmune kidney disease. 

If the FDA clearance goes through, the oral drug called voclosporin will be the first commercial product developed successfully by Aurinia, a drugmaker founded in 1993 and based near Vancouver, Canada. Voclosorin has the potential to deliver $1 billion or more in annual sales, but Aurinia has never launched a drug before, and it must do so during a Covid pandemic and with Big Pharma competition. 

“We’re in a show-me phase right now, we know that, but we look forward to doing it,” said Aurinia CEO Peter Greenleaf, in an interview with STAT’s Adam Feuerstein. 

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More reads

• Former Merck employee arrested for stealing trade secrets on cancer research. (STAT)
• Drug makers sue HHS over a discount program serving low-income populations. (STAT)
• Meet Binney Street Capital: Dana-Farber Cancer Institute’s first venture fund. (FierceBiotech) 
• Medicare Part D spent twice what the VA paid for the same drugs. (STAT)