Amgen, Inc.

Intermittent panitumumab and FOLFIRI showed promising progression-free survival in RAS/BRAF wild-type metastatic colorectal cancer patients, with median progression-free survival of 11.2 months (continuous) and 17.5 months (intermittent). The intermittent approach reduced toxicity and allowed more time off treatment.

BLINCYTO®, a BiTE® therapy for CD19+ B-cell precursor ALL, was invented in 1994 and approved by the FDA in 2014. It treats various ALL stages, including relapsed or refractory disease, and has significant safety concerns like Cytokine Release Syndrome and Neurological Toxicities. BLINCYTO has transformed B-ALL treatment globally, with multiple approvals since 2014.

aTyr Pharma appoints Eric Benevich to its Board of Directors, effective December 10, 2024. Benevich, currently Chief Commercial Officer at Neurocrine Biosciences, brings over 30 years of pharmaceutical commercial experience. aTyr is a clinical-stage biotech focused on tRNA synthetase biology for fibrosis and inflammation therapies.

Amgen's scientists, trained by Nobel laureates, drive groundbreaking research. Christy Tinberg, cited in the 2024 Chemistry Nobel Prize, exemplifies this, having developed a novel computational method for protein design. Other Amgen researchers trained by Nobel winners include Shane Caldwell, Robert Vernon, Kate Ashton, and more, contributing to advancements in protein design, drug discovery, and diagnostics.

The Inflation Reduction Act gave CMS power to negotiate drug prices, but Public Citizen warns of patent abuses and evergreening tactics by manufacturers, costing Medicare billions in potential savings.

The global oncology-based in-vivo CRO market was valued at USD 1.4 billion in 2024 and is expected to grow at an 8.8% CAGR from 2025 to 2034, driven by demand for immuno-oncology therapies, advancements in in-vivo models, and growing oncology drug approvals from small biotech and pharmaceutical companies. Small firms lead in oncology drug approvals, focusing on innovative treatments like CAR-T cell therapy and monoclonal antibodies. The market is segmented by service, model, end use, and region, with preclinical testing dominating. Key trends include the rise of immunotherapies, outsourcing by biotech firms, AI integration, and strategic alliances between companies and CROs.

A review in *Blood Cancer Discovery* outlines a major multiple myeloma research project that supported the FDA's decision to greenlight minimal residual disease (MRD) as a biomarker endpoint for accelerated drug approval, potentially cutting a decade off the drug development process. The research, led by C. Ola Landgren and Sean Devlin, examined how MRD measurements correlate with clinical outcomes, leading to the FDA committee's 12-0 vote in April 2024 to allow MRD as a clinical trial endpoint for accelerated approval in multiple myeloma.

The USPTO withdrew a proposed rule to add a new requirement for terminal disclaimers to overcome non-statutory double patenting, favoring big pharma over biosimilar developers. The decision was based on 349 comments, with big pharma's outweighing those favoring the change.

Bob advises startups, companies, and research institutes on global patent and trademark acquisition in biotechnology, including molecular biology, cancer therapies, gene therapy, and next-generation sequencing. His practice includes patent prosecution, landscape analysis, opinion work, and due diligence. Bob has extensive biopharma experience, managing high-value IP assets and trademark portfolios, and has led IP for commercial and Phase I biologics.

Despite headwinds, the techbio sector continues to attract significant investment and drive innovation, exemplified by the 2024 launch of Xaira, backed by over $1 billion, aiming to design novel therapeutic proteins using advanced AI. The sector is maturing through strategic consolidation, significant capital deployment, technical diversification, and steady clinical validation, as illustrated by 25 techbio organizations, including notable players like Isomorphic Labs, Generate:Biomedicines, Recursion Pharmaceuticals, and Schrödinger Inc., all leveraging AI for drug discovery. Emerging players such as Archon Biosciences, AION Labs, and Antiverse are also making strides, while established companies like Insilico Medicine and Ginkgo Bioworks continue to expand their platforms and partnerships.