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STAT+: Axsome wins FDA nod for Alzheimer’s agitation

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The FDA named Katherine Szarama acting head of CBER as it continues to search for a permanent leader. Julia Vitarello is launching a new effort to scale bespoke medicines after her first startup faltered.

And Matt Herper reflects on the legacy of genomics pioneer J. Craig Venter, whose vision helped shape modern biotech.

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Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

The FDA named Katherine Szarama acting head of CBER as it continues to search for a permanent leader. Julia Vitarello is launching a new effort to scale bespoke medicines after her first startup faltered.

And Matt Herper reflects on the legacy of genomics pioneer J. Craig Venter, whose vision helped shape modern biotech.

Continue to STAT+ to read the full story…

Read More

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Federal appeals court blocks mailing of abortion pill mifepristone

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A federal appeals court has restricted access to one of the most common means of abortion in the U.S. by blocking the mailing of mifepristone prescriptions.

Friday’s unanimous ruling from a three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals is requiring that the abortion pill be distributed only in person and at clinics, overruling regulations set by the federal Food and Drug Administration.

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Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more

Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more

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Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-break moment for Bristol …​ ​Read More

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Arvinas’ ‘Protac’ breast cancer drug cleared by FDA

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Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.

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