Alexis Kramer
@alexis_s_kramer
Deputy Editor at @endpts. Past: @BLaw veteran. Artist, Snowboarder, Tennis Player. Tweets are my own, retweets not endorsements.
Significant update to this story on what could be required, from @ZacharyBrennan $SRPT
Updated: In a follow-up conversation on the safety study, the senior official said Sarepta could make a change to the dosing or manufacturing, and test it on the next 10 or 12 boys, and show the liver-related issues were improved
Exclusive: $SRPT would have to conduct new studies to get back on market, FDA official says - CBER review staff are 'unanimous' that Elevidys should never return to market endpoints.news/sarepta-would-…
Trump's online loyalty enforcer Laura Loomer goes after the FDA's Vinay Prasad endpoints.news/trump-loyalty-…
Under RFK, the FDA’s approval of 3 mRNA vaccines has sharply divided his supporters. Some believe the agency has taken necessary steps to limit the products. Others think virtually nothing has been done to stop the use of mRNA-based shots. @maxonwifi endpoints.news/fdas-continued…
We are closely reporting on @Sarepta and the FDA's request to stop selling its Duchenne treatment If you have any tips, please contact me on Signal at jaredwhitlock.73, including if you work at Sarepta or were recently let go in this week's layoffs.
Breaking: Sarepta cuts 500 workers, agrees to Elevidys black box warning endpoints.news/sarepta-lays-o…
Curious if any of the @EnergyCommerce Dems will ask FDA's Jacqueline Corrigan-Curay about KalVista: endpoints.news/sources-fda-ch…
3,500 FDA employees received final termination notices on Monday. Affected employees were part of the April 1 layoffs. endpoints.news/fda-employees-…
This has turned into an annual summer tradition of mine — analyzing compensation trends across the biopharma world In today's story, I analyzed 475 CEO pay packages, finding the 20 highest-paid for 2024: endpoints.news/the-highest-pa…
The Supreme Court recently declined to wade into a fight over a state’s regulation of pharmacy benefit managers. But legal experts say it likely won’t be the last time the broader issue makes its way up to the high court. via @Nicole_DeFeudis endpoints.news/the-fight-over…
Breaking: KalVista wins FDA approval for HAE drug after Makary's short-lived attempt to intervene. endpoints.news/fda-approves-k…
The CDC will recommend RSV vaccines for all at-risk adults in their 50s, expanding its current guidance on the shots. RFK Jr. adopted the recommendations of the now-fired ACIP members. With @maxonwifi endpoints.news/cdc-expands-rs…
What we learned from RFK’s reconstructed ACIP x.com/i/broadcasts/1…
If you work at the FDA, I am interested to hear more about your perspective. Please consider reaching out to me on Signal: my username is adunn123.30 endpoints.news/sources-fda-ch…
🚨 alarm-worthy scoop 🚨 @AndrewE_Dunn reports that @DrMakaryFDA personally sought the rejection of KalVista's drug. Scientists pushed back and sources described the move as "extraordinary interference into the agency’s day-to-day operations." endpoints.news/sources-fda-ch…
BREAKING: Acting CDER chief is retiring from FDA. endpoints.news/acting-cder-ch…
Top FDA officials sided with biotech CEOs this week on the need to speed up drug reviews to stay competitive with China and other countries, in the latest agency “listening” session with industry. @maxonwifi endpoints.news/fda-to-biotech…
FDA's cell and gene therapy top leaders let go in the latest agency shake-up. endpoints.news/fdas-top-cell-…
Breaking news for @endpts: New ACIP members Martin Kulldorff and Robert Malone both were paid experts against Merck in civil cases. Kulldorff weighed in on Gardasil and Malone did work challenging the company's mumps vaccine efficacy. endpoints.news/two-new-acip-p…
FDA Commissioner Makary said he wasn’t involved in RFK's decision to fire every member of a key CDC expert panel that guides national vaccine policy. @maxonwifi and @ZacharyBrennan endpoints.news/fda-chief-maka…
