Day: December 2, 2021

Califf, nominee to lead FDA, asks Woodcock to stay in leadership role if he’s confirmed

WASHINGTON — Robert Califf, President Biden’s pick to lead the Food and Drug Administration, has asked Janet Woodcock, who has served as the FDA’s acting commissioner for the last 11 months, to stay on in a leadership role at the agency should he be confirmed by the Senate, two sources with knowledge of the discussion […]

STAT+: Former Immunomedics executives are charged with insider trading

Two former executives at Immuomedics were charged with insider trading by U.S. authorities in connection with information about late-stage clinical trial results of a promising cancer drug, which later prompted Gilead Sciences (GILD) to buy the company. Usama Malik, who had been chief financial officer, and Lauren Wood, the former chief communications officer, were arrested […]

Virtual care companies rush to ease access to Covid-19 antivirals

As two new antiviral pills for Covid-19 approach emergency authorization, experts are concerned that a lack of public health infrastructure — especially easy access to fast-turnaround testing and quickly filled prescriptions — will prevent them from making a meaningful dent in the pandemic. “We know that these antivirals are going to have a window of […]

Carlos del Rio on Covid antivirals, an FDA conundrum, & the rise of Omicron

Will the first Covid-19 pill be all that useful? How worrisome is Omicron? And when will it be safe to congregate? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, STAT’s Matthew Herper joins us to talk about a tense debate among FDA advisers about molnupiravir, a Merck […]

STAT+: Hospitals and doctors fail to stop end-of-year Medicare cuts, for now

WASHINGTON — Hospitals and physicians lost a lobbying battle to stave off Medicare cuts of up to 10% in a must-pass government spending bill, though the defeat may not be final. Lawmakers reached a bipartisan deal on Thursday that would extend government funding at current levels through Feb. 18, with very few extra provisions added […]

Most advanced lab-grown human embryos prompt a pressing question: Are they getting too real?

The stem cells were no more than a week old when scientists moved them from their slick-walled plastic wells into ones lined with a thin layer of human endometrial tissue. But in that time, the cells had multiplied and transformed, organizing themselves into semi-hollow spheres. Per the instructions of the chemical cocktail in which they’d […]

Second U.S. case of Omicron variant indicates domestic transmission

Health officials on Thursday reported the country’s second Covid-19 infection from the Omicron variant in a Minnesota resident who notably did not travel internationally recently, unlike the first case. The case in Minnesota is an adult male who had been vaccinated and who lives in Hennepin County, which includes Minneapolis, state health officials said. He […]

STAT+: Pharmalittle: Glaxo and Vir drug appears to work against Omicron; employees sue Bristol Myers over vaccine mandate

Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of maple […]

The Key Elements of Great

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