Zachary Zubulake

DCAT Week 2026 | Created with Canva - Spray Dryer Image courtesy of ESTEVE CDMO

 draws together a pharmaceutical supply chain sector navigating familiar pressures: drug shortages, geopolitical risk, and the ongoing demand for domestic manufacturing resilience.

 Three announcements timed to coincide with the event reflect distinct strategies for responding to those pressures.

Is the Case for Domestic Finished Dose Manufacturing Getting Stronger?

LGM Pharma is committing an additional $9 million to its facilities in Rosenberg, Texas, and Colorado Springs, Colorado, bringing its total investment across both sites to $15 million.

 The announcement builds on a $6 million expansion at the Texas facility completed in 2025 and is aimed at expanding commercial capacity, extending research and development capabilities, and meeting sustained demand for U.S.-based drug product manufacturing.

In Texas, $4 million will go toward expanding commercial-scale manufacturing suites for suppositories, driven in part by increasing demand in women's health.

 The site will also gain expanded development capabilities for formulations including solutions, suspensions, and semi-solids. In Colorado Springs, a $5 million investment will increase commercial manufacturing capacity for niche oral solid dose products, with a particular focus on orally disintegrating tablets. This format is in growing demand as the domestic oral solid dose market continues to expand.

"These multi-site investments totaling $15 million reflect our continued commitment to strengthening pharmaceutical supply chains in the United States," said Prasad Raje, chief executive officer, LGM Pharma, in a press release.

The company is building finished dose capacity at the downstream end of the supply chain while pairing it with upstream active pharmaceutical ingredient sourcing through a network of more than 220 pre-qualified manufacturers.

 "Today's pharma companies need partners that are both resilient and integrated across the full product lifecycle," Raje added.

 "By reinforcing domestic drug product manufacturing at the downstream end of the supply chain, closer to end markets, and leveraging our global API sourcing capabilities upstream, we create a balanced end-to-end model."

Importantly for companies with active programs, both facilities will remain fully operational throughout construction.

 "Rather than overextending in a single phase, we are executing these enhancements incrementally to expand capabilities and capacity while ensuring operational continuity," said Hamilton Lenox, chief commercial officer, LGM Pharma, in the press release.

How Far Can a Single Molecular Class Extend Across Markets?

ICE Pharma, a global leader in Ursodeoxycholic Acid, is using DCAT Week to announce a deliberate move beyond the traditional active pharmaceutical ingredient supplier model.

The company is repositioning its bile acid platform to serve finished dosage, nutraceutical, and specialty excipient markets.

 First is a focus delivering finished dosage forms of Ursodeoxycholic Acid to complement its established ingredient business. As well, advancing nutraceutical solutions targeting gut health and metabolic balance. They also plan on expanding bile acid derivatives into functional excipients designed to enhance formulation performance.

"ICE Pharma is evolving beyond the traditional API supplier model by exploring and developing new applications of bile acids, with the goal of opening new market opportunities," said Agostino Barazza, chief executive officer, ICE Pharma, in a press release.

The move reflects a broader trend of ingredient suppliers seeking to capture more value across the product chain.

For pharmaceutical developers working with bile acid chemistry, the shift may offer more integrated options for sourcing and formulation support. "Bile acids are an underutilized but highly versatile molecular class," added Dr. Roger Viney, chief commercial officer, ICE Pharma, in a press release.

 "Our strategy is to leverage our chemistry, regulatory expertise and manufacturing infrastructure to provide integrated solutions — not just ingredients — to pharmaceutical and healthcare partners."

What Innovations Are Being Shown for Development Pipelines?

ESTEVE CDMO is announcing an expansion of its spray drying infrastructure at its facility in Celrà, in Spain's Girona region, alongside the launch of a new brand identity.

 The expansion adds a 3,000-square-meter production unit to accommodate new spray drying equipment within purpose-built high-potency containment suites.

According to Esteve, their GEA Pharma spray dryer is scheduled to be operational in the first quarter of 2027, followed by a second unit expected to come online later that year.

 The new building also includes infrastructure to accommodate a commercial-scale third dryer, with further expansion beyond that planned. The company expects to add up to 15 staff once the first two units are in operation.

"As our work in Girona progresses, it is important that we remain aligned with the needs of our partners, and adding spray drying capabilities can help solve problems they face with the characteristics of development pipelines, such as stability, poor solubility, potency, and scalability," said Joan Petit, President, ESTEVE CDMO, in a press release.

Taken together, these announcements reflect a sector investing in specificity, whether that means deeper domestic infrastructure, extended chemistry platforms, or targeted capabilities for complex molecules.

 DCAT Week 2026 continues to offer concrete signals about where the industry is being built upon.

LGM Pharma. LGM Pharma expands U.S. manufacturing, bringing total investment to 15 million dollars across Texas and Colorado sites [press release]. Boca Raton, FL; March 19, 2026. 

https://www.businesswire.com/news/home/20260319065768/en/LGM-Pharma-Expands-U.S.-Manufacturing-Bringing-Total-Investment-to-%2415M-Across-Texas-and-Colorado-Sites

ICE Pharma. ICE Pharma expands beyond APIs to capture new bile acid markets [press release]. Milan, Italy. ICE Pharma; 2026.

​ESTEVE CDMO. ESTEVE CDMO plans additional spray dryers and containment in Girona, Spain, and launches new brand [press release]. Celrà (Girona), Spain; March 19, 2026. 

https://www.esteve.com/global/media/news/esteve-cdmo-plans-additional-spray-dryers-and-containment-in-girona-spain-and-launches-new-brand

Articles

DCAT Week 2026 highlights supply-chain strategies shaped by shortages, geopolitical exposure, and resilience mandates. LGM Pharma is investing $15 million across Texas and Colorado to expand U.S. finished-dose capacity, adding suppository suites, formulation development, and niche oral solids including ODTs while maintaining operations during construction. ICE Pharma is extending its bile-acid platform beyond APIs into finished dosage, nutraceuticals, and functional excipients to capture more downstream value. ESTEVE CDMO is expanding high-containment spray-drying infrastructure in Girona to address solubility, stability, potency, and scale-up needs.

Pharma companies reveal capacity expansions and strategic pivots at DCAT Week 2026, signaling where supply chain investment is heading.

DCAT Week 2026: Key Pharma Manufacturing Announcements

FDA’s CNPV Approves Wegovy HD | Created with Canva

On March 19, 2026, the FDA approved a 7.2 mg dose of semaglutide injection (Wegovy HD) for weight reduction and long-term weight maintenance in adults with obesity, or in adults who are overweight with at least one weight-related condition.

filing as part of the FDA Commissioner’s National Priority Voucher pilot program.

"The new FDA is moving with unprecedented efficiency on products that advance national priorities," said FDA Commissioner, Martin Makary, MD, MPH, in a press release.

 "Today's approval is another demonstration of what the FDA can accomplish when we try bold new things."

What Does the Clinical and Safety Package Tell Us?

The approval of Wegovy HD was supported by clinical data showing that the 7.2 mg dose produced additional average weight reduction compared to previously approved doses of semaglutide.

 In patients with both obesity and type 2 diabetes, blood sugar lowering, measured as hemoglobin A1C, was similar between the higher and lower doses. The safety profile was described as consistent with the established profile for the drug class.

Semaglutide is a glucagon-like peptide-1 receptor agonist, a mechanism now well-characterized in both regulatory and manufacturing contexts.

 The most frequently observed adverse reactions were gastrointestinal: nausea, vomiting, diarrhea, constipation, and abdominal pain. These are consistent with what has been documented at lower doses.

“Since its launch in 2021, Wegovy® has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk,” said Mike Doustdar, president and CEO, Novo Nordisk, in a press release.

 “Earlier this year, we launched the Wegovy® pill, and with the accelerated approval of Wegovy® HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy® HD to help even more people reach their weight and health goals.”

One finding of interest to formulation and clinical development teams is a higher-dose-specific signal.

 Reports of altered skin sensation, described as sensitivity, pain, or burning, occurred more frequently at 7.2 mg than at lower doses. These reactions generally resolved on their own or with dose reduction. The FDA has noted it is conducting further investigations into this reaction, which suggests the agency considers the signal to warrant ongoing pharmacovigilance attention rather than resolved characterization.

The product carries a boxed warning for the potential risk of thyroid C-cell tumors based on rodent study findings.

 It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, consistent with labeling across the semaglutide class.

The approval was granted to Novo Nordisk.

 The Wegovy HD approval offers a concrete data point on both dose-dependent safety characterization and on what an expedited review pathway can look like in practice, details worth incorporating into regulatory strategy discussions as the pilot program continues to evolve.

What Does a Warning Letter Alongside a Priority Approval Mean?

The approval comes against a complicated regulatory backdrop for Novo Nordisk.

On March 5, 2026, the FDA issued a Warning Letter to Novo Nordisk Inc. following an inspection conducted in early 2025, citing serious violations of postmarketing adverse drug experience reporting requirements, including failures to submit safety reports within required 15-day timelines and inadequate investigation of certain adverse events. The inspection identified what the agency described as systemic failures across surveillance, receipt, evaluation, and reporting processes, and raised concerns extending beyond the inspected products to the company's broader portfolio.

The juxtaposition is instructive as a company can simultaneously receive an expedited approval under a priority program and face significant compliance scrutiny in pharmacovigilance.

 It serves as a reminder that speed to approval and post-approval obligations operate in parallel, and that gaps in safety reporting infrastructure carry consequences regardless of a product's commercial or regulatory profile.

U.S. Food and Drug Administration. FDA approves fourth product under National Priority Voucher Program, higher dose semaglutide [news release]. March 19, 2026. Accessed March 20, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-fourth-product-under-national-priority-voucher-program-higher-dose-semaglutide

Novo Nordisk. Wegovy HD (semaglutide 7.2 mg) approved by US FDA [company announcement]. March 19, 2026. Accessed March 20, 2026. 

https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916516

​ U.S. Food and Drug Administration. Novo Nordisk Inc 717576 03/05/2026 [warning letter]. March 5, 2026. Accessed March 20, 2026. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-717576-03052026

FDA approved semaglutide 7.2 mg injection (Wegovy HD) for chronic weight management in adults with obesity or overweight with comorbidity, using the National Priority Voucher pilot with a 54‑day review. Clinical data showed incremental mean weight loss versus lower semaglutide doses, with similar HbA1c reduction in patients with obesity and type 2 diabetes. Safety was consistent with GLP‑1 RA expectations, predominantly GI events, but higher-dose–associated dysesthesia-type skin sensations emerged. A boxed thyroid C‑cell tumor warning and MEN2/MTC contraindications remain, amid concurrent FDA pharmacovigilance compliance scrutiny of Novo Nordisk.

The FDA approved higher-dose semaglutide (7.2 mg) in 54 days under its new priority voucher program, signaling faster reviews for drug developers.

New Wegovy Dose Approved Under FDA’s CNPV

FDA's NAM Guidance | Image Credit: © Tada Images - stock.adobe.com.

On March 18, 2026, the FDA issued a draft guidance document outlining a validation framework for new approach methodologies used in drug development.¹ This move has direct implications for how nonclinical safety data are generated, assessed, and submitted across the industry.

The guidance describes general recommendations for validating new approach methodologies when nonclinical data is provided in support of a drug application.¹ These methodologies include complex in vitro systems, two-dimensional in vitro models, in chemico studies, and in silico approaches. For teams involved in preclinical program design, understanding this framework is increasingly important as regulatory expectations shift.

This development reflects a broader legislative and regulatory trajectory.¹ In 2022, Congress passed legislation clarifying that nonanimal alternatives can be used to support an investigational new drug application or a biosimilar biologics license application in lieu of animal studies. The guidance builds on that legislative foundation and aligns with the agency's Roadmap to Reducing Animal Testing in Preclinical Safety Studies, published in April 2025.

What Does the Validation Framework Require?

The guidance organizes its recommendations around four core features: context of use, human biological relevance, technical characterization, and fit-for-purpose assessment.¹ The context of use must clearly define the intended regulatory purpose of the methodology. Acceptable examples identified in the guidance include supporting dosage selection, addressing the mechanistic understanding of an adverse event seen in animals and/or humans, justifying not using an animal species because it does not add value to regulatory decision-making, and helping to support a weight of evidence approach and predicting risks typically not measured in humans.

Human biological relevance is another central pillar.¹ The guidance calls on sponsors to describe the physiological features being assessed, including the relevance of cell types used, species of origin, and how anatomical and physiological characteristics involved in toxicology findings may be mimicked in the platform. For a hepatotoxicity model, for instance, the guidance specifies that the model should contain the relevant cell types and biological features to recapitulate the hepatocellular physiology observed in vivo. For neurotoxicity assessments, the choice of neural cellular composition and cellular architecture may affect biological and functional baseline characteristics and should be carefully considered when selecting an appropriate model.

On technical characterization, sponsors are expected to document test method parameters including dosing frequency, substance preparation, detection instrumentation, and potential sources of assay variability.¹ Biological variability, including genetics and donor variability, must be described, and the selection of reference compounds such as positive and negative controls must be defined and justified. For platforms such as organ-on-a-chip devices, additional documentation is required around flow, shear stress, matrix properties, and evidence ruling out interactions between the test article and the platform itself.

Does a Methodology Need to Be Validated Before it can Be Used?

This is a question many development teams will have, and the guidance addresses it directly.¹ The agency states that for a new approach methodology to be considered for review in drug development, the test does not necessarily need to be validated. A fit-for-purpose methodology, even if not validated, may adequately address specific toxicological concerns.

Thw agency is clear that when a methodology is used, it is always in the context of the weight of evidence, considering the specific concerns about that product based on prior knowledge and any preclinical toxicological information provided.¹ The guidance distinguishes between validation, which establishes accuracy, reliability, and relevance for a specific context of use, and qualification, which is a separate determination under the agency's drug development tool program. Both can support regulatory review, but validation is described as critical to establishing the reliability of data for specific situations.

The fit-for-purpose standard is defined in terms of a methodology's contribution to regulatory decision-making.¹ A methodology may fulfill one of three drug development objectives: replacing or offering an alternative to traditional methods, filling a data gap where traditional models are unavailable or insufficient, or confirming and complementing findings from traditional methods. In practical terms, this gives development teams flexibility in how they position a methodology within a broader nonclinical package.

The agency has already accepted some methodologies under this framework. Certain approaches that evaluate eye irritation, skin irritation, and skin sensitization have been accepted as fit-for-purpose, including in vitro reconstructed human epidermis assays used to predict risk for human skin sensitization in place of the local lymph node assay in mice.

The agency encourages sponsors to consult with the applicable review division if there is uncertainty about the suitability of the method for regulatory use.¹ Especially when considering use of a nonanimal testing method believed to be suitable, adequate, and feasible for a proposed regulatory use. Early engagement is recommended, with interactions expected to focus on indication-, disease-, organ-, and endpoint-specific considerations.

How Does FDA's Broader Modernization Agenda Affect Drug Developers?

The agency's modernization push extends beyond methodology validation.² 

The FDA also launched a unified platform for analyzing adverse event reports, the FDA Adverse Event Monitoring System.

 The system consolidates what had previously been a patchwork of seven separate databases. The new system enables adverse event reports for drugs, biologics, vaccines, and cosmetics to be displayed in a single dashboard, with real-time publication replacing the prior quarterly release cycle. The agency estimates savings of approximately $120 million over five years. The shift toward real-time postmarket surveillance data represents another dimension of the agency's broader modernization agenda.

U.S. Food and Drug Administration, Center for Drug Evaluation and Research. General Considerations for the Use of New Approach Methodologies in Drug Development: Guidance for Industry. Draft guidance. March 2026. 

https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-alternatives-animal-testing-drug-development

U.S. Food and Drug Administration. FDA launches new Adverse Event Look-Up Tool [news release]. March 11, 2026. Accessed March 19, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool

FDA’s March 2026 draft guidance proposes a validation framework for new approach methodologies (NAMs) supporting nonclinical safety in drug applications, reinforcing the post-2022 authorization of nonanimal alternatives and aligning with the 2025 animal-testing reduction roadmap. Expectations center on defining context of use, demonstrating human biological relevance, technical characterization, and fit-for-purpose performance. Notably, NAMs need not be fully validated to inform review if fit-for-purpose within a weight-of-evidence package. In parallel, FDA modernized postmarket analytics via a unified, real-time adverse event monitoring platform.

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

What FDA's NAM Guidance Means for Pharmaceutical Development

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug biodistribution studies and first-in-human dose accuracy.

Why PDX Models Improve Radiopharmaceutical Biodistribution Studies

Denis Beckford Vera, Head of Radiopharmacology, Champion Oncology, makes a case for incorporating patient-derived xenografts (PDXs) into the early stages of radiopharmaceutical development. He argues that doing so leads to more accurate, clinically relevant results and fewer costly setbacks down the line.

At the core of Vera's argument is the value of biodistribution studies conducted in PDX models rather than traditional immortalized cell lines. PDX tumors more faithfully replicate the architecture, vascularity, and receptor density of real patient tumors. They give researchers a far truer picture of how a radiopharmaceutical will actually behave in the body. Vera explains, "If you start early in the development using these patient-derived xenografts to evaluate the biodistribution of your radiopharmaceutical, even to choose lead compounds, you're going to have the real assessment of how your radiopharmaceutical is behaving."

One of the distinctive advantages of radiopharmaceuticals, is their inherent visibility. Researchers can directly observe where a compound travels and how it accumulates, making biodistribution an especially powerful tool for optimization. This real-time insight can streamline the path from preclinical research to first-in-human trials.

A major concern he raises is the tendency to overestimate first-in-human doses when relying on conventional cell line models, which often exhibit artificially high and homogeneous receptor expression. PDX models, by contrast, capture the heterogeneity seen across and within patients. Vera explains, "If you, from the beginning, use clinically relevant, preclinical models like patient-derived xenografts, you will have a real understanding of how much this drug is going to the tumor, and then that will directly impact the first-in-human dose estimation."

Ultimately, Vera's message is one of efficiency and precision, building on clinically relevant models from the outset reduces the likelihood of having to return for costly re-optimization later in development.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

I'm Denis Beckford Vera. I am the head of radiopharmacology at Champion Oncology. This is very related to clinical translation. So if you start early in the development using these patient-derived xenografts to evaluate the biodistribution of your radiopharmaceutical, even to choose lead compounds, you're going to have the real assessment of how your radiopharmaceutical is behaving. Moving from biodistribution, I think biodistribution should be the first type of assessment that you do preclinically in these, clinically relevant models, to understand where target engagement, for instance, in the tumor. How this tumor heterogeneity, and how this, tumor architecture, that mimics the patient's tumor, can really affect the biodistribution of the radiopharmaceutical, which is very tied to vascularity, for example. It is different in immortalized cell lines than in real patient samples. The receptor density and how the receptors distribute between the tumor and between, different patients and the lesions between the same patient as well. So you're going to get an idea of how this can really distribute. More importantly, you can really save time because with radiopharmaceuticals, you have something that you don't have with other modalities. You can see, you can see your real molecule. So if you are able to see where it goes and how it behave where it goes. So then you can optimize the process for later efficacy studies in this same tumor model. Even further, if there is a biologically relevant species, you can also identify off-target toxicity as well doing biodistribution studies, which is very important, very relevant to, to these types of treatments. From the beginning, you are evaluating your compound in clinically relevant models. You later don't have to come back and do optimization, what happens many times. So this is what happens, when you use biodistribution to assess a first-in-human studies and to estimate first-in-human doses. So many times, this dose is overestimated, based on these regular cell line-derived xenografts. We have high receptor expression, in many cases, has more homogeneous receptor expression. And then you're saying, you are getting a wrong understanding on how much your drug is really accumulating in those tumors. So if you, from the beginning, use clinically relevant, preclinical models like patient-derived xenografts, you will have a real understanding of how much this drug is going to the tumor, and then that will directly impact the first-in-human dose estimation. So you will not have to go back and do, or you will have the probability that you will have to go back and do so much optimization to improve in human doses and things like that, will be less likely, than if you went right.

Videos

FDA Approves J&J’s Icotrokinra | Created with Canva

), an interleukin-23 receptor antagonist for the treatment of moderate-to-severe plaque psoriasis.¹ 

This treatment, developed by Johnson & Johnson

 in collaboration with Protagonist Therapeutics, is designed for adults and pediatric patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy.

The approval marks a meaningful shift in the oral small molecule and peptide therapeutic landscape.¹ Unlike existing oral agents, icotrokinra is a targeted oral peptide, which has historically faced significant bioavailability and selectivity challenges in development. Its successful path through Phase III represents a proof of concept that peptide-based receptor antagonism can be delivered orally at therapeutic levels, a finding relevant to pipeline programs exploring similar modalities.

The drug works by binding to the IL-23 receptor with high affinity, inhibiting downstream signaling in human T cells.¹ The clinical significance of receptor occupancy data is noted as unknown, but the mechanism positions icotrokinra at the same biological target as several approved injectable biologics.

What Does the Clinical Evidence Base Look Like?

The approval rests on the Iconic program, a Phase III development package spanning five studies and approximately 2,500 patients.¹ This dataset is notable for its scope and for the simultaneous enrollment of adult and adolescent populations, which often requires separate development tracks.

The package included duplicate head-to-head superiority trials (Iconic-Advance 1 and 2) against deucravacitinib, an approved oral tyrosine kinase 2 inhibitor.¹ Across those trials, roughly 70% of patients achieved an Investigator's Global Assessment score of 0 or 1 and approximately 55% reached a 90% improvement in Psoriasis Area and Severity Index score at Week 16. Running head-to-head trials in duplicate is an uncommon regulatory strategy and reflects a deliberate effort to generate robust comparative evidence.

Safety data through Week 16 showed adverse reaction rates within 1.1 percentage points of placebo, with no new safety signals identified through Week 52.¹ The most common adverse reactions were headache, nausea, cough, fungal infection, and fatigue. From a benefit-risk modeling perspective, the clean short-term profile, combined with a once-daily oral regimen taken on an empty stomach, presents a favorable adherence scenario compared with injectable alternatives.

"With new guidance from the International Psoriasis Council that clarifies when to move beyond cycling on topical treatments to systemic therapy, an innovative option like ICOTYDE is a potential game-changer for many adult and adolescent patients," said Linda Stein Gold, MD, director of Dermatology Clinical Research, Henry Ford Health, in a press release.¹

What Are the Downstream Implications for the Pipeline?

Johnson & Johnson retains exclusive worldwide development and commercialization rights under its license and collaboration agreement with Protagonist.¹ Icotrokinra is now in active investigation across additional indications (psoriatic arthritis (two studies), ulcerative colitis, and Crohn's disease) meaning the manufacturing and regulatory infrastructure built for this approval will need to scale accordingly.

The oral peptide format raises specific process considerations around stability, formulation, and GMP production that differ from both small molecules and conventional biologics.¹ The fact that the molecule can be dispersed in water and is dosed on an empty stomach suggests formulation constraints that likely shaped the development and manufacturing strategy.

"At Johnson & Johnson, we are harnessing our scientific expertise to transform cutting-edge science into meaningful solutions for patients," said John Reed, MD, PhD, executive vice president, R&D, Innovative Medicine, Johnson & Johnson, in the press release.¹ "ICOTYDE is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment. The approval of ICOTYDE represents a pivotal moment for people with plaque psoriasis.”

How far Does the Oral Peptide Precedent Extend Beyond Psoriasis?

The icotrokinra approval arrives alongside broader momentum in Johnson & Johnson's targeted therapy pipeline.² At the European Association of Urology's 2026 Annual Meeting, the company presented Phase I results for erdafitinib intravesical drug-releasing system (Erda-iDRS), an investigational intravesical delivery system designed to release the kinase inhibitor erdafitinib directly into the bladder over three months, which minimizes systemic exposure while sustaining localized drug levels.

In 62 patients with recurrent intermediate-risk non-muscle-invasive bladder cancer harboring fibroblast growth factor receptor alterations, the complete response rate reached 89%, with a median response duration of 18 months.²

"The high and durable complete responses demonstrated with Erda-iDRS highlight the opportunity to deliver a targeted therapy to these patients," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson, in a press release.² Phase III studies are ongoing.

Johnson & Johnson. FDA approval of ICOTYDE (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. News release. March 17, 2026. Accessed March 18, 2026. 

https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide

​Johnson & Johnson. Johnson & Johnson highlights promising first-in-human ERDA-IDRS (formerly TAR-210) results in intermediate-risk non–muscle-invasive bladder cancer. News release. March 18, 2026. Accessed March 18, 2026. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-highlights-promising-first-in-human-erda-idrs-formerly-tar-210-results-in-intermediate-risk-non-muscle-invasive-bladder-cancer

FDA approval of icotrokinra, an oral IL‑23 receptor–blocking peptide, expands systemic options for moderate-to-severe plaque psoriasis in patients ≥12 years and ≥40 kg. The Phase III Iconic program (~2,500 participants) included duplicate superiority head-to-head trials versus deucravacitinib, yielding Week‑16 IGA 0/1 rates near 70% and PASI90 around 55%. Adverse events were comparable to placebo at Week 16 and remained without new signals through Week 52. Commercialization now supports expansion into psoriatic arthritis and IBD; J&J also advanced intravesical erdafitinib with 89% complete responses in FGFR-altered NMIBC.

The FDA approves icotrokinra, the first targeted oral peptide blocking the IL-23 receptor, for moderate-to-severe plaque psoriasis with Phase III data across 2,500 patients.

FDA Approves First Oral Peptide for Plaque Psoriasis

SGD Pharma’s Sterile Nasal Vial Platform | Created with Canva

On March 17, 2026, SGD Pharma announced a strategic original equipment manufacturer collaboration with Prince Sterilization Services, LLC to validate ready-to-use type I glass primary packaging solutions for the North American market.¹ The first commercial outcome of that collaboration is the My Sterinity Nasal platform, a flexible cleaned vial range built on SGD Pharma's existing My Sterinity platform that will be formally introduced at DCAT Week 2026 in New York.

The announcement signals the availability of a regionally qualified, end-to-end supply chain for sterile Type I glass nasal vials, an offering that has historically been difficult to source with short lead times in the US.¹

Why Is the Nasal Delivery Market Drawing Renewed Attention to Glass Packaging?

The global nasal drug delivery market is valued at approximately €9 billion ($10.4 billion) and encompasses more than 2 billion units annually.¹ Plastic has historically dominated this segment, accounting for roughly 88% of packaging formats. However, the therapeutic profile of nasal drug programs is shifting. What was once a market concentrated on acute and rescue treatments is now expanding into chronic, high-value indications for conditions that include Alzheimer's disease, Parkinson's disease, multiple sclerosis and depression.

These longer-duration therapies place more demanding requirements on primary packaging.¹ Formulation teams need containers that offer strong chemical inertness, consistent barrier protection and long-term biocompatibility. Minimizing adsorption of active compounds, preserving sterility over extended treatment courses and enabling precision dosing are increasingly non-negotiable for this category. Type I borosilicate glass satisfies these criteria in ways that plastic alternatives often cannot.

What Will the SGD Pharma and Prince Collaboration Deliver?

My Sterinity Nasal launches initially in three vial formats--0.5 mL, 7.5 mL and 10 mL--that are available in both clear and amber glass.¹ The vials are based on SGD Pharma's U-Save type I glass and offer controlled particulate and endotoxin levels, validated sterility assurance and compatibility with standard preservative-free nasal pump systems. They are packaged in double-bagged trays for immediate deployment in filling operations.

The division of responsibilities in the collaboration is designed to address a practical gap in the North American supply landscape.¹ Glass manufacturing will take place at SGD Pharma's Saint Quentin La-Motte facility in northern France, which holds ISO 15378 certification and operates to GMP standards. Prince will then handle washing, depyrogenation and sterilization services on the North American side, creating a qualified, regional supply chain suited to US biopharmaceutical customers.

Carole Grassi, chief commercial marketing & innovation officer, SGD Pharma, said in a press release,¹ “Our collaboration with Prince marks an important milestone in SGD Pharma's innovation growth strategy for North America. The My Sterinity Nasal platform represents a major step forward in high-value nasal drug delivery, and our collaboration with Prince unlocks immediate US-qualified capacity for biopharma customers scaling complex nasal therapy programs. This is more than a product launch, it is a validated supply chain ready to support qualification, clinical trials and commercial launch with unmatched speed and reliability.”

Daniel Prince, PhD, CEO, Prince Sterilization Services, said, in the press release,¹ "SGD Pharma's Type I glass expertise combined with our quality focused and flexible RTU & sterilization platform creates the gold standard for sterile nasal packaging. Prince's recent US qualification means we can now deliver ready-to-use, terminally sterilized My Sterinity Nasal vials in timelines that match domestic and international customer development cycles and exceed quality requirements."

The practical implication is access to terminally sterilized, type I molded glass vials without the delays typically associated with custom qualification projects or international shipping timelines.¹ SGD Pharma's broader type I molded glass portfolio is characterized by high hydrolytic resistance, low thermal expansion. This being relevant for lyophilization and autoclaving processes.

What Else Is Being Presented at DCAT Week 2026?

Alongside the My Sterinity Nasal launch, SGD Pharma will present two additional glass packaging technologies at DCAT Week.¹ 

Sealian is an internal surface treatment designed to improve chemical durability and barrier performance for sensitive drug formulations

. The company will also present Idency premium vials, which are engineered to provide greater chemical and mechanical resistance than standard tubular vials while retaining the same outer diameter. Idency allows integration with existing filling line configurations without equipment modification.

SGD Pharma will not be alone in addressing supply chain resilience in injectable and specialty drug segments.² Avenacy, a US-based specialty pharmaceutical company, will discuss its portfolio of twenty-six critical acute care and shortage injectable medications. The company is using the conference to engage potential customers and partners around further product launches aimed at stabilising supply in high-demand categories.

Lotte Biologics will also be present at DCAT Week 2026, using the event to advance CDMO partnership discussions in the North American market and beyond.³ The company plans to highlight the combined capabilities of its Syracuse bio campus in New York and Plant 1 at its Songdo facility in Incheon, South Korea. Lotte will present a cell line development to drug substance production timeline of approximately 8.5 months, achieved through a partnership with Asimov. Manufacturing support spans monoclonal antibodies, bispecific antibodies and both clinical and commercial-scale production. The presences of these organizations at DCAT Week 2026 reflects a broader industry preoccupation with qualified, reliable supply chains for complex drug delivery formats.

SGD Pharma. SGD Pharma advances its North American pharmaceutical glass offering in new collaboration with Prince Sterilization Services, LLC – debuting its My Sterinity Nasal range at DCAT Week 2026. Paris La Défense, France: SGD Pharma; March 17, 2026. Press release.

​Avenacy. Avenacy to attend 2026 DCAT Week. Business Wire. March 16, 2026. Accessed March 18, 2026. 

https://www.businesswire.com/news/home/20260316315025/en/Avenacy-to-Attend-2026-DCAT-Week

Korea Biomedical Review. Lotte Biologics to participate in DCAT Week 2026 in New York. Korea Biomedical Review. March 17, 2026. Accessed March 18, 2026. 

https://www.koreabiomed.com/news/articleView.html?idxno=30848

SGD Pharma and Prince Sterilization Services have established an OEM collaboration to validate ready-to-use Type I glass primary packaging for North America, debuting the My Sterinity Nasal platform at DCAT Week 2026. The initiative addresses persistent US sourcing constraints for sterile nasal vials by creating a regionally qualified, end-to-end supply chain. Momentum reflects a nasal delivery market shifting from acute use toward chronic, high-value CNS and immunologic indications, increasing the need for inertness, barrier performance, sterility retention, and dosing precision.

SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like Alzheimer's and Parkinson's.