PharmTech Weekly Roundup - February 20, 2026

This week, we’re seeing a strategic shift toward advanced modalities like cell therapies and targeted protein degradation, alongside a structural pivot to rare disease assets to stabilize portfolios against those looming patent cliffs everyone’s talking about, as well as global R&D competition.

First up, in our Ask the Expert series, regular hosts, Susan Schniepp or Nelson Labs and Siefried Schmitt of Parexel highlight that while orphan drug pathways offer financial incentives and expedited timelines, manufacturers must adapt to the complexities of small-batch production and the need for more agile, high-level quality systems.

Roche announced on Monday a Phase III milestone for Gazyva, which met its primary endpoint of showing superior complete remission in primary membranous nephropathy, marking a major expansion of this molecule into autoimmune kidney disease.

On Tuesday, BMS announced that FDA had accepted the New Drug Application for iberdomide, a first-in-class CELMoD agent for relapsed/refractory multiple myeloma. In a new, transformative approach meant to significantly accelerate the regulatory pathway, the NDA for iberdomide is utilizing minimal residual disease negativity as a primary endpoint.

GSK had a big week. On Tuesday, The European Commission approved the company’s depemokimab, brand name Exdensur, the first and only ultra-long-acting biologic in the EU to treat respiratory disease which has an only twice-yearly dosing schedule. GSK also announced new effective data for its RSV vaccine, including reduced hospitalizations in adults aged 60 or older and reduced major adverse cardiovascular events in the same population during RSV-related hospitalization.

J&J announced on Wednesday that it’s investing over $1 billion in a new next-generation cell therapy facility outside of Philadelphia to localize production, ensure supply chain resilience for oncology and neurology pipelines, and create 500 specialized biomanufacturing jobs.

Also on Wednesday, Eli Lilly announced it had struck a strategic licensing deal with CSL regarding the IL-6 monoclonal antibody clazakizumab. Under the agreement, CSL gets an upfront payment of $100 million and remains eligible for future clinical, regulatory, and commercial milestones, as well as royalties on global net sales, while Lilly will be responsible for exploring development, global regulatory approval, and distribution of the treatment to patients with end-stage kidney disease.

In part three of a four-part article series on rare diseases, Nathan Edwards and Michael Bianco, both of Arya Consulting Partners, examine how revenue concentration and accelerating patent cliffs undermine the traditional blockbuster model, whereas orphan drugs offer a structurally different strategy for stabilizing biopharma portfolios through more durable, predictable, and risk-adjusted long-term value creation. Be sure to check out all 4 parts.

We end with a warning issued from FDA Commissioner Marty Makary, who said in a TV interview that the US is losing ground to China in early-stage drug development, calling for urgent regulatory reforms to streamline IND applications and trial contracting to maintain Western leadership in R&D speed. The comments suggest that development teams will need to balance the leveraging of speed and capacity of China’s developers with US scrutiny on clinical data provenance, trial diversity, and biosecurity.