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Sydney Lupkin
@slupkin
Correspondent at . Past: , , , // DM for Signal
Washington, DCJoined February 2009

Sydney Lupkin’s Tweets

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Would you take a drug if it was still awaiting a confirmatory study to show it really worked? What if I told you some #pharma companies take years to even START those studies? And make millions of dollars in the meantime. My latest for :
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A year ago today, a leaked opinion showed us the Supreme Court planned to gut Roe v Wade. It launched an unforgettable summer, where we saw in real time the sweeping impact of losing abortion rights. Here is how it felt to live through those days:
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🧵: Discrimination against moms is an "open secret" in many workplaces. Workers are still being laid off while on leave, pushed out of jobs or subjected to comments like, “You probably have your hands full at home." There is little legal recourse.
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Read through this entire thread, and hire these folks. saved my life many times — and is an audio hero to so many (like THE reason I wanted to stay at NPR at all). If you are upset and have power in the audio industry, reach out to this team about… Show more
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Well, looks like my time with NPR is up. Gutted that @NPRinvisibilia the show I love & have given 7+ yrs of my life to has "stopped production". Gutted to not get to work with my brilliant teammates. Gutted that me & some 100 colleagues I admire have lost our jobs. This sucks.
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I wondered what they'd say after hearing on last night! I think this is the contract listing: caleprocure.ca.gov/PSRelay/ZZ_PO. Looks like it goes back to Dec. 2017. So $54 million OVER 5 YEARS? Not much to a company with a $30 billion (with a b) market cap.
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.@GavinNewsom’s office just released some details on what it means for California to break ties w Walgreens. This says the state is not renewing a contract worth about $54m that allows CA to buy prescription drugs from Walgreens for use mostly by the department of corrections:
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When I found out I would be one of just two journalists traveling with President Biden to Ukraine, my first question for the White House was how I would be able to pump. My essay about going to Kyiv fresh off maternity leave:
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🚨New Study Alert🚨 Critical evidence when considering Pfizer and Moderna's attempts to increase the price of 'their' mRNA Covid-19 vaccines.
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📢 NEW STUDY: From 1985 to 2019, the United States invested at least $337 million of public funding into critical research & development that directly led to mRNA Covid-19 vaccines. 💰 We document the specific public 💵💵💵 that were crucial for success in @bmj_latest ! 🧵 1/
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A pregnant woman was devastated to learn one of her twins wouldn't make it to birth. Then, it got worse. "You can't do anything in Texas, & I can't tell you anything further in Texas, but you need to get out of state." New from
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But there's no firm requirement for these studies to be ongoing at the time of accelerated approval, which means regulators, doctors and patients can be waiting YEARS for answers. Check out my story for here:
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When two of its follow-up drugs, Vyondys 53 and Amondys 45, received accelerated approval, their confirmatory trial was already initiated with 75 percent enrollment, according to the company. That trial is expected to wrap up on time - a few months AHEAD of the Exondys 51 trial.
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When I asked Sarepta about this in May, the company said the first part of the trial was already complete and it was enrolling for the second, but declined to tell me how many children were enrolled so far.
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I asked Sarepta about its muscular dystrophy drug as part of my accelerated approvals reporting project that pubbed this month for , but that part wound up getting cut because, well, the story (below) was already pretty long. npr.org/sections/healt
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$SRPT will be submitting its 4th accelerated approval BLA since 2016. Yet to complete a confirmatory study for any of its previous 3 AA's investorrelations.sarepta.com/news-releases/
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When FDA granted Sarepta's first accel approval, in 2016, they asked for confirmatory trials to be completed by late 2020. But results are not expected for another few yrs. FDA should be given (as it has requested) more authority to require these trials be underway at approval.
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$SRPT will be submitting its 4th accelerated approval BLA since 2016. Yet to complete a confirmatory study for any of its previous 3 AA's investorrelations.sarepta.com/news-releases/
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#mustread Excellent deep look at the "broken bargain" for faster action on accelerated approvals. Kudos to
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Would you take a drug if it was still awaiting a confirmatory study to show it really worked? What if I told you some #pharma companies take years to even START those studies? And make millions of dollars in the meantime. My latest for @npr: npr.org/sections/healt
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ICYMI, 's piece is a fantastic deep dive into the accelerated approval program - its origins, its transformation over time, and how its latest challenges pose problems for patients, physicians, and payers alike.
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Would you take a drug if it was still awaiting a confirmatory study to show it really worked? What if I told you some #pharma companies take years to even START those studies? And make millions of dollars in the meantime. My latest for @npr: npr.org/sections/healt
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Deep dive into flaws in the accelerated approval process featuring insights from and among others. One line: "But for nearly 18 years on the market, Clolar's most important confirmatory clinical trial remained incomplete." 1/2
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Would you take a drug if it was still awaiting a confirmatory study to show it really worked? What if I told you some #pharma companies take years to even START those studies? And make millions of dollars in the meantime. My latest for @npr: npr.org/sections/healt
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Would you take a drug if it was still awaiting a confirmatory study to show it really works? What if you had cancer and were running out of time? My latest investigation for tackles accelerated approvals. Check it out!
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Imagine making more than $230 million in sales on a drug for over a decade…and that drug never finished going through the required studies to prove it was actually effective!! 🤯 Highly recommended this investigation from
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The strong chemo was still awaiting evidence, but Kristi's son was out of options. "It's just kind of this big, ugly circle that no one wants to be in because...damned if you do, damned if you don't." Read @NPR's #acceleratedapprovals investigation: npr.org/sections/healt
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