Quality/GMPs

GSK’s B7-H3-targeted ADC has shown durable responses in SCLC, supporting regulatory momentum and advancing targeted approaches for high-unmet-need lung cancers.

Data from a Phase III trial showed durable survival benefit with PD-L1 blockade plus chemotherapy, reinforcing the use of immunotherapy in curative-intent GI cancer settings.

Regulatory acceptance of tildrakizumab's sBLA signals a potential expansion of IL-23 inhibition into joint disease, an area in which treatment gaps persist for a substantial share of psoriatic disease patients.

The companies’ new immunology-driven mAb, which targets an immune-evasion pathway in myeloproliferative neoplasms, is advancing toward first-in-human trials.

Data from the MajesTEC-9 Phase III trial shows teclistamab as monotherapy improves survival, indicating a shift in multiple myeloma treatment.

Phase III trial results show that trastuzumab deruxtecan reduced invasive recurrence or death 53% in patients with residual HER2-positive disease after neoadjuvant therapy.

China’s approval of Sciwind’s ecnoglutide for weight management, alongside the company’s Pfizer commercialization deal, intensifies competition in the global GLP-1 market.

Johnson & Johnson reports encouraging Phase 1b data for its bispecific antibody pasritamig in combination with docetaxel in metastatic castration-resistant prostate cancer, showing strong PSA responses and manageable safety

Siegfried Schmitt, PhD, vice president, Technical at Parexel, notes how it is necessary to search beyond the term “data integrity” to stay abreast of developments in this field.

FDA’s priority review designation of Regeneron Pharmaceuticals’ garetosmab underscores Activin A inhibition as a potential disease-modifying strategy for genetically driven ossification disorders.

In the second half of an interview with Lonza’s Carrie Mason, Mason discusses how cross-training scientists enables scale-up of AI-enabled bioprocessing.

FDA’s breakthrough therapy designation for Johnson & Johnson’s co-formulated bispecific antibody therapy validates dual EGFR/MET targeting in HPV-negative head and neck cancer.

Phase III data showed sustained IL-5 suppression with 48–58% exacerbation reduction and significant CRSwNP score improvements across 52 weeks.

FDA’s IND clearance advances CStone’s trispecific antibody into Phase II development, expanding multispecific immunotherapy in solid tumors.

FDA’s acceptance of Precision BioSciences’ IND advances ARCUS gene excision toward clinical validation, signaling progress for durable DMD therapies.

Akeso’s bispecific antibody gains momentum on the NMPA’s designation, while Phase III data advance a new first-line option for advanced biliary tract cancer.

PharmaResearch’s DOT-based nanoparticle platform enters US clinical testing, highlighting delivery innovation aimed at improving tolerability in solid tumor therapies.

FDA’s acceptance of Affinia Therapeutics’ IND positions the company to test lower-dose, heart-targeted AAV gene therapy for BAG3 cardiomyopathy.

Regulatory review of Eisai’s subcutaneous lecanemab highlights how delivery innovation may expand access and scalability for disease-modifying Alzheimer’s therapies.

This fast track designation signals growing regulatory momentum for trispecific antibodies as the myeloma field pushes beyond single-target immunotherapies.

The European Commission’s approval of GSK’s Arexvy for adults 18 years and older expands the respiratory syncytial virus vaccine market and signals broader adoption of adult immunization strategies.

Green chemistry is emerging as a strategic lever for biopharma manufacturing, enabling safer processes, efficiency gains, and long-term competitiveness.

EU regulators clear Otsuka’s antisense injectable to prevent hereditary angioedema attacks, reinforcing momentum for RNA-based rare disease medicines.

The approval of aflibercept for visual impairment from macular edema following retinal vein occlusion is based on clinical data that suggests higher-dose anti-VEGF therapy can preserve vision while extending dosing intervals.

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.