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Alnylam Validates Subcutaneous Delivery Technology With Strong Phase I Results

 
• By Lisa LaMotta

The RNA interference-focused biotech will bring the rest of its pipeline forward with subcutaneous technology now that it has been validated in human studies, but the company will continue to pursue approval of its lead candidate as an infusion product.

Alnylam Pharmaceuticals Inc. is on the cusp of making another strategic transition – the company released top-line data from an early study of its first subcutaneous RNA interference drug that effectively means the rest of the pipeline will be brought forth with the new administration technology.

Preceding an R&D day held by the company in New York on July 11, Alnylam announced that ALN-TTRsc achieved greater...

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• By Bridget Silverman

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.