Selina Koch

2 weeks ago | biocentury.com | Selina Koch

ARTICLE | Editor's CommentaryFragmented systems limit Europe’s launch appeal — but targeted, regional actions could strengthen its position, help preserve access to innovation By Selina Koch, Executive EditorInvestors breathed a sigh of relief when last week’s MFN executive order appeared too vague to advance. But make no mistake: drug price controls remain a U.S. political priority.

1 month ago | biocentury.com | Selina Koch

ARTICLE | RegulationThe FDA commissioner says he’ll retain existing structure, which will require recruiting staff to fill critical positions By Steve Usdin, Washington EditorFDA Commissioner Marty Makary has rejected a staff proposal to reorganize the agency, he said in a recent interview. The proposed reorganization, which circulated widely on Capitol Hill, alarmed former FDA leaders and biopharma CEOs who predicted that it would render the agency dysfunctional.

1 month ago | biocentury.com | Selina Koch

ARTICLE | Product DevelopmentAn advancing wave of new candidates, spanning diverse modalities, converges with push for surrogate endpoint status By Selina Koch, Executive EditorIs tau the new amyloid? Leaders in the Alzheimer’s field have high conviction in tau — both as a target and surrogate endpoint — and they aren’t letting a string of clinical misses deter them. Sound familiar?

1 month ago | zephyrnet.com | Selina Koch

ARTICLE | Discovery & TranslationBy Selina Koch, Executive EditorAs it terminates NIH grants, the Trump administration has largely targeted politically charged areas such as DEI and COVID-19 research. Yet, Alzheimer's disease research - with no direct ties to these issues - has also been swept up in the purge, with more such projects, in Alzheimer's and other diseases, almost certain to follow.

1 month ago | biocentury.com | Selina Koch

ARTICLE | Discovery & TranslationAlzheimer’s research joins list of NIH-funded projects disrupted by terminations, freezes By Selina Koch, Executive EditorAs it terminates NIH grants, the Trump administration has largely targeted politically charged areas such as DEI and COVID research. Yet Alzheimer’s disease research — with no direct ties to these issues — has also been swept up in the purge, with more such projects, in Alzheimer’s and other diseases, almost certain to follow.