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Leadership

Longer ACNU Rule Review Gets Kennedy Signature

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

Regenxbio’s Triple Threat: Partnered Programs, DMD Progress And In-House Manufacturing

Regenxbio is riding a wave these days, with all three of its clinical-stage programs set to reach critical milestones this year and recent positive news on its DMD gene therapy, just as Sarepta suffered a setback with a death related to its DMD treatment. In Vivo spoke with CEO Curran Simpson about the company’s plans and strategic decisions.

Mirum’s Rare Disease Strategy: A Blueprint For Sustainable Growth

From a $7m discarded asset to a $336m commercial portfolio, In Vivo looks inside Mirum Pharma’s disciplined strategy for identifying, acquiring and revitalizing overlooked rare disease programs while building toward billion-dollar potential.

US FDA Survives First Day Of Return To In-Office Work, But True Test Upcoming

Parking and security at the FDA’s White Oak headquarters were strained from the influx of employees who had to report to work in person on 17 March.

Amgen’s Research VP On Goldilocks Viscosity, AI’s Hinge Moment

Amgen’s AI model to predict proteins in the “bright Goldilocks zone of viscosity” with over 80% accuracy minus a wet lab experiment holds immense potential, VP Research Haldar said at an event as he spoke about a “hinge moment” for AI in pharma

Makary US FDA Nomination Advances, Last Minute Hiccup May Offer Clues On Mifepristone

President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.

Q&A: Rentschler’s CEO On The CDMO’s Pivot Away From Cell And Gene Therapy And More

Rentschler Biopharma CEO Benedikt von Braunmühl tells In Vivo about the CDMO's strategic decision to exit the cell and gene therapy manufacturing space.

HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI

Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.

‘Creating An Environment Where Women Can Thrive’ – Accord’s Carter Discusses The BGMA Women’s Networking Group

Marking International Women’s Day, Generics Bulletin speaks to Accord’s UK country manager Clara Carter about her role as chair of the BGMA’s new Women’s Networking Group.

India CDMOs Seek To Counter China With New Industry Body, See Europe As Ally

Indian CDMOs could consider collaborating with allies in Europe amid a focused effort via a new industry body to counter existing challenges like China’s manufacturing, regulatory and policy advantages and a shortage of funding and talent in the country even as talk of US tariffs throws a new spoke in the wheel