Day: July 8, 2021

STAT+: House Democrats say pharma stock buybacks and dividends exceed R&D spending

A Congressional committee released a report on Thursday showing the 14 largest drug makers spent more on stock buybacks than research and development during the last five years, the latest sign that the cost of prescription medicines remains a political hot potato in Washington. Specifically, the companies spent $577 billion on stock buybacks and dividends […]

Listen: Aduhelm’s latest twist, how Covid variants are shaping the summer, & a digital health boom

How worrying is the Delta variant? Is there a digital health bubble? And what is going on at the FDA? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss the latest twists following the FDA’s widely condemned decision to approve Aduhelm, Biogen’s treatment for Alzheimer’s disease. […]

STAT+: FDA’s expansive Alzheimer’s drug approval surprised even top agency officials

WASHINGTON — The Food and Drug Administration’s contentious decision to approve a new Alzheimer’s drug for every single patient with the disease surprised even top FDA officials involved in the deliberations, two senior staffers told STAT. One of the sources went further, saying they would never have supported the faster approval process that the FDA […]

STAT+: Former Genentech scientist convicted of stealing trade secrets given to former JHL Biotech execs

A former Genentech principal scientist and her husband were convicted of stealing trade secrets and providing the information to a Taiwanese company, which then parlayed the purloined data to reach a $101 million partnership with Sanofi (SNY) to develop medicines. Xanthe Lam, who worked for Genentech from 1986 through 2017, helped to siphon information about […]

Study highlights need for full Covid vaccination to protect against Delta variant

In the welter of news about the Delta variant spreading around the world, one theme has emerged: This form of the virus that causes Covid-19 is challenging, but vaccination works to protect people against it. A new study published Thursday in Nature adds new detail about the dominant variant, analyzing how well Delta, in a […]

Gene hunters turn up new clues to help explain why Covid-19 hits some people so hard

On March 16, 2020, five days after the World Health Organization declared Covid-19 a global pandemic, Andrea Ganna, a geneticist at the Institute for Molecular Medicine Finland, took to Twitter to make an announcement: “We are launching the ‘COVID-19 host genetics initiative,’” he wrote. He asked other scientists to join him and institute director Mark […]

STAT+: Purdue reaches deal with 15 states in a significant step toward bankruptcy plan approval

Fifteen states have agreed to drop their long-standing objections to a contentious bankruptcy plan to reorganize Purdue Pharma, a significant step that will likely ensure the proposal will be approved in court next month. As part of the deal with the states, the drug maker agreed to a “material expansion” of a public repository that […]

STAT+: Pharmalittle: In rare move, FDA revises label for Biogen Alzheimer’s drug; former compounding exec gets added jail time

Good morning, everyone, and how are you today? The sun is trying to peek through a muggy haze descending this morning on the Pharmalot campus, where the official mascot is hunting for rabbits, and assorted birds and bugs can be heard in the distance. As for us, we are immersed in our usual routine of […]

STAT+: FDA, under fire from critics, revises prescribing information for Biogen’s Alzheimer’s drug

The Food and Drug Administration on Thursday changed the prescribing label for Biogen’s Alzheimer’s treatment Aduhelm — narrowing its recommended use to patients with milder forms of the disease. Biogen and the FDA described the Aduhelm label update as a clarification meant to better reflect data from clinical trials. But the move will also be […]

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