Day: July 15, 2021

STAT+: Expert panel votes down Fibrogen’s anemia pill due to safety risks, making U.S. approval unlikely

A panel of outside experts convened by the Food and Drug Administration concluded Thursday that the risks of blood clots and other safety concerns tied to Fibrogen’s anemia pill were too high to support the drug’s approval for patients with chronic kidney disease. The FDA is not required to abide by the panel’s recommendations, but […]

STAT+: Expert panel votes unanimously that Biogen Alzheimer’s drug doesn’t offer patient benefits

A prominent panel of medical experts unanimously voted that there is no evidence to suggest the recently approved Alzheimer’s drug offers patients any health benefits beyond the usual care. The meeting, which was convened to review both clinical and cost effectiveness of the new drug, is the latest blow to Biogen (BIIB) and its efforts […]

NIH’s Francis Collins: For Biden’s new research agency to succeed, it should prepare for some projects to fail

WASHINGTON — Francis Collins is ready for the National Institutes of Health to fail spectacularly. At least, he’s ready for a few of the agency’s potential new projects to go up in flames: the high-risk, high-reward pursuits that would come out of a new research wing that President Biden has proposed. The potential for earth-shattering […]

Listen: The FDA’s future, Biden’s tight ship, & the latest Aduhelm twist

Who’s going to run the FDA? Why isn’t the Biden administration leakier? And what if Aduhelm isn’t a blockbuster after all? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we’ll talk about the future of the FDA, whose acting commissioner will have to step down in November […]

STAT+: DeepMind and a rival release dueling code for protein-folding AI

Computational biologists have been on tenterhooks for the past seven months, ever since DeepMind took a hammer to one of their field’s most persistent challenges: accurately predicting the 3D shape of a protein from its amino acid sequence. The Alphabet-owned AI research outfit had developed a neural network that predicts protein structures with near-perfect accuracy, […]

By creating mouse eggs entirely from scratch, researchers raise the prospect of a futuristic fertility treatment

The tiny clump of mouse cells didn’t look like an ovary. For one thing, it was much smaller, microscopic. And instead of being attached to a uterus it was floating in a test tube. And yet, from within the pocket of cells, oocytes began to form, then grow, maturing into eggs. Later, when some of […]

STAT+: U.K. issues record fine to drug makers for price gouging and collusion schemes

After a lengthy investigation, the U.K. antitrust regulator has fined several drug makers a record-setting $370 million for their role in an “egregious” scheme to significantly hike the cost of medicines and delay the sale of lower-cost versions. At issue was the cost of hydrocortisone tablets, which cost the U.K. government and taxpayers $110 million […]

STAT+: Pharmalittle: FDA head admits possible missteps in Alzheimer’s drug approval; two major health systems won’t administer Biogen drug

Top of the morning to you and a fine one, it is. Moderate temperatures and clear skies are enveloping the Pharmalot campus this morning, a pleasant respite from the mugginess of the past couple of days. Nonetheless, nothing will stop us from reaching for a steaming cup of stimulation. Our choice today is cinnamon hazelnut, […]

Opinion: Sickle cell disease and a pivotal moment to end health inequality

Covid-19 laid bare the long-standing vulnerability of minority and low-income communities in U.S. society and its health system even as we celebrated the power of scientific innovation to rein in the pandemic. It’s time to turn that innovation, driven by an even greater mind shift, to end inequality in treatment. In perhaps no condition is […]

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