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.U.S. 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

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

#OTD in 1953, Julius and Ethel #Rosenberg were executed for conspiracy to commit espionage during the #RedScare. Learn more from author steve usdin and others: c-span.org/classroom/docu…. #USHistory #APUSH #APGov #GovChat #SSChat #EdChat #OTDH #OnThisDay

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

The case for amylin in obesity: a conversation with #ZealandPharma President & CEO Adam Steensberg on #TheBioCenturyShow hosted by Stephen Hansen 🇺🇦 buff.ly/xEuQE7T

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

A leaked memo on Biotechnology Innovation Organization strategy is energizing anti-vaxxers, writes BioCentury's steve usdin. Document describes BIO's investment in pro-vaccine communications, plans to engage with conservatives in and outside the Trump administration biocentury.com/article/656351

FDA’s FDA Biologics “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

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

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…

Link: fda.gov/news-events/pr…

As Sarepta Therapeutics loses platform designation, the U.S. FDA pathway’s future is uncertain. #GeneTherapy #FDA $SRPT buff.ly/N1OG1EB

New U.S. 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

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

theguardian.com/us-news/2025/j…

$GSK's Blenrep gains approvals in Europe and Canada to kick off its comeback story, but will FDA make an example of the ADC in its push for comprehensive dose optimization? buff.ly/G0ey2oc

With one third of its 2024 sales at risk of LOE, how #Bayer hopes to build a bridge back to growth via its launches of #Nubeqa and #Kerendia, despite flagging hopes for former blockbuster prospect asundexian $BAYN buff.ly/LVsyJEb

Prasad's ouster from U.S. FDA raises prospect of CBER reset: Uncertainty fueled by ideology, politics is increasing, but when dust settles industry and advocates may be happier, says steve usdin in BioCentury: biocentury.com/article/656627

Can masked biologics uncover new value by dialing down tox? An emerging wave of conditionally activated biologics is widening the therapeutic windows of validated tumor and checkpoint targets buff.ly/5KrPzB5