|Articles|February 19, 2016

Therapeutic Innovation & Regulatory Science: An Increasingly Global Approach

Author(s)DIA

Therapeutic Innovation & Regulatory Science: An Increasingly Global Approach

A series of contributions emphasizing the increasingly global nature of medical product development and regulation is highlighted in this issue with contributions from around the world. Additional articles on central monitoring, clinical trial outcomes, and data quality are also included.

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Pharmaceutical Executive Daily: FDA Approves Tecentriq

The FDA approves Roche’s Tecentriq for a subset of colon cancer patients, TRexBio and Retension Pharmaceuticals price new IPOs, and a Pharmaceutical Executive feature examines what it takes to turn precision medicine’s biological gains into deliverable therapies.

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Naoki Okamura: Post-Patent Plan and Purpose

Astellas CEO Naoki Okamura is putting a “patient axis” operating model, a broader portfolio of strategic brands and a new generation of science to work in the company’s bid to return to record growth.

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The Future of Precision Medicine Depends on More Than Biology

As established gains in personalized and targeted therapy have enabled increasingly precise approaches to disease, novel technologies are expanding what is possible while creating new challenges for drug developers.

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Roundup: TRexBio & Retension Pharmaceuticals Announce IPO Pricing

TRexBio and Retension Pharmaceuticals priced IPOs, raising a combined $161.7 million to advance their immunology and hypertension pipelines ahead of their Nasdaq debuts.

Roche’s Tecentriq gains an adjuvant colon cancer indication tied to mismatch repair testing, with a 50% lower recurrence or death risk reported in ATOMIC. Credit: Stock.Adobe.com/Pakin

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FDA Approves Tecentriq for Stage III dMMR Colon Cancer

The FDA approved Tecentriq plus chemotherapy for stage III dMMR colon cancer, Roche’s 12th US indication for the immunotherapy.

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The Most Important Lessons Learned from Building CGT Supply Chains: LogiPharma 2026

Pharma's chain of custody model is migrating into food and consumer goods — and becoming a cross-industry differentiator.

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Pharmaceutical Executive Daily: Ultragenyx Sells Rare Pediatric Disease Priority Review Voucher

Ultragenyx sells a rare pediatric disease priority review voucher for $210 million, Viatris acquires Pacira BioSciences for $1.65 billion, and Peter Young surveys a steadying biopharma outlook.

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A Steadying Trajectory: Biopharma Review and Outlook

Improved financing conditions and accelerating M&A are creating new opportunities, but policy uncertainty, patent expirations and persistent funding pressures continue to shape the outlook for pharma and biotech.

Therapeutic Innovation & Regulatory Science: An Increasingly Global Approach

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Roundup: TRexBio & Retension Pharmaceuticals Announce IPO Pricing

Ultragenyx to Sell Rare Pediatric Disease Priority Review Voucher for $210 Million

Roundup: Shionogi Inc. Acquires IntraBio, Gate Bioscience extends Collaboration with Eli Lilly, Alector Enters Global License Agreement with Genentech

Viatris Acquires Pacira BioSciences for $1.65 Billion

FDA Approves Tecentriq for Stage III dMMR Colon Cancer