steve usdin
@steveusdin1
Washington Editor, BioCentury. Author: Bureau of Spies & Engineering Communism.
Shifting FDA standards are making approvals less predictable. Replimune, surprised by a CRL Tuesday, joins 3 cos disrupted since May - Ultragenynx, Caprior, Immunitybio . Can firms still rely on pre-January FDA guidance? What are the new standards? biocentury.com/article/656558
As @Sarepta loses platform designation, the @US_FDA pathway’s future is uncertain. #GeneTherapy #FDA $SRPT buff.ly/N1OG1EB
New @US_FDA CDER Director Tidmarsh is taking over an agency in crisis. The media will focus on his controversial COVID comments, but industry wants to know if he can right the ship. buff.ly/ScS9MVU
Third death from a Sarepta gene therapy, patient was in phase 1 trial of limb-girdle muscular dystrophy Type 2. Cause was acute liver injury. Regulators, patient advocates have been informed. biocentury.com/article/656520…
In a memo to CBER staff, director Prasad said he’s hiring “lots of reviewers.” Also criticizes media: “My advice is don’t believe everything you read.” ($) biocentury.com/article/656389
FDA’s @FDACBER “hiring many new people (lots of reviewers) to support our mission,” its director Vinay Prasad told staff. The hires will include former staff, he said. Prasad also urged staff to come to him w/safety concerns. More ($) biocentury.com/article/656389
A leaked memo on @IAmBiotech strategy is energizing anti-vaxxers, writes @BioCentury's @steveusdin1. Document describes BIO's investment in pro-vaccine communications, plans to engage with conservatives in and outside the Trump administration biocentury.com/article/656351
Leaked memo on BIO strategy energizes anti-vaxxers. It describes BIO's investment in pro-vaccine comms, plans to engage on vaccine policy w/ conservatives in and outside Trump administration, to portray vaccines as an economic & national security issue. biocentury.com/article/656351
The case for amylin in obesity: a conversation with #ZealandPharma President & CEO Adam Steensberg on #TheBioCenturyShow hosted by @StephenPHansen buff.ly/xEuQE7T
Amarin, Merck alum Karim Mikhail emerges as possible head of FDA’s CDER The former Amarin CEO and Merck executive is serving as an adviser to Commissioner Makary. biocentury.com/article/656239
#OTD in 1953, Julius and Ethel #Rosenberg were executed for conspiracy to commit espionage during the #RedScare. Learn more from author @steveusdin1 and others: c-span.org/classroom/docu…. #USHistory #APUSH #APGov #GovChat #SSChat #EdChat #OTDH #OnThisDay
The death of a second boy in a trial of Sarepta’s DMD gene therapy is tragic. FDA Comm. Makary and CBER Dir Prasad have an opportunity to demonstrate leadership by investigating the unusual approval and charting a course forward for DMD patients. biocentury.com/article/656215
.@US_FDA's Makary, Prasad balance vows to speed reviews with industry criticism. Promise “massive” changes in biosimilars regulation and a new rolling submissions pathway, express support for Trump’s ‘most favored nation’ drug pricing policies. buff.ly/4ao452N
.@PearlF Brad Smith's conflicts have been known for some time. Here's an excerpt from a story (biocentury.com/article/655235) I wrote in February:
First-in-class DLL3 confirms benefit as target’s pipeline expands. Amgen’s Immdelltra reduces risk of death by 40%. #ASCO25 abstracts highlight up-and-coming DLL3 programs buff.ly/NE1iQ6M
The biopharma industry is racing to counter the Trump MFN threat: With White House demanding 85% across-the-board drug price cuts, the biopharma industry hopes to avoid catastrophic policies via alternative concessions, writes @BioCentury's @steveusdin1 biocentury.com/article/656077
Setback for Stealth raises questions about @US_FDA’s implementation of rare disease policies. The biotech’s regulatory odyssey in Barth syndrome exemplifies the problems Makary has vowed to fix. via @SteveUsdin1 in @BioCentury biocentury.com/article/656066