Drug Development

Effective modeling and simulation can reduce physical experimental requirements, ASD development risks, and time to market.

Novartis paused 8 CAR T-cell trials after 3 deaths. Bristol Myers also paused a rival program. What it means for cell therapy developers.

Novartis licenses Alteogen's ALT-B4 enzyme for subcutaneous drug conversion in a deal worth up to $3.2B, signaling formulation industry shift.

Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, discusses microstructure intelligence in more detail in part 2 of this preview of the company’s keynote presentation at AAPS PharmSci 360.

The finalists for the 2026 CPHI Pharma Awards span 15 categories including API development, digital transformation, manufacturing, supply chain, sustainability, and leadership, with winners revealed October 6 at CPHI Milan.

In part 1 of this 2-part preview of AAPS PharmSci 360’s keynote on predictive drug development, Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, explains microstructure intelligence and how it can enhance how drug developers understand the dosage form.

In August 2026, Heidi Overton was nominated for FDA commission, and a wave of oncology and neuro drugs were approved.

Lilly is set to acquire Merida Biosciences for up to $2.875B, gaining a precision autoantibody-degrading platform led by phase 1 candidate MER511.

Four FDA approvals in the areas of HIV, diabetes, autoimmune disease, and COVID-19 vaccines came in a flurry in late August 2026.

This week’s PharmTech.com content covered AI agent authority, hold-time and nitrosamine risk frameworks, biologics formulation, 3D bioprinting, and major oncology and dealmaking news.

As the biologic pipeline diversifies across ADCs, bispecific antibodies, and fusion proteins, formulation science has become the critical discipline bridging molecular complexity and patient-ready therapy.

FDA approves Rasonque (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer, validating RAS(ON) inhibition for future drug development.

Centrix and University of Sussex launch a data analytics partnership to reduce development risk, rework and delays in early-stage pharma programs.

Continuous direct compression can provide a simplified alternative pathway for selected spray-dried dispersion formulations when supported by a material-property-driven development strategy.

European biotechs are advancing bioinks and high-resolution bioprinting for medical devices and regenerative tissues.

FDA priority review of Jemperli for biomarker-defined rectal cancer signals capacity, supply chain, and global filing shifts for manufacturers.

McKesson will acquire Precision Medicine Group for $2.25B, integrating clinical research and commercialization services within its oncology segment.

REGENXBIO's RGX-121 faces an FDA clinical hold after asymptomatic spine MRI findings, highlighting long-term imaging surveillance for CNS gene therapies.

The FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSDIa, raising manufacturing and post-market monitoring questions.

The FDA approves first therapy shown to reduce new bone lesions and flare-ups in fibrodysplasia ossificans progressiva (FOP), based on a 63-patient trial using CT-scan efficacy endpoints.

The Trump administration nominates Heidi Overton for FDA commissioner amid leadership instability, raising questions for drug developers on review timelines and oversight.

FDA grants Priority Review to Teva's ecopipam new drug application, backed by phase 3 data. Ecopipam is a first-in-class D1 receptor therapy for pediatric Tourette syndrome.

The collaboration will use Andelyn’s viral vector process to produce clinical-grade material for an upcoming gene therapy trial.

LEO Pharma acquires dersimelagon from Tanabe Pharma for up to $435M, adding a late-stage oral rare dermatology asset under FDA review.

This episode of PharmTech Explained discusses how China's biotech surge is reshaping US drug licensing, manufacturing control, and FDA data trust, the key shifts pharma professionals must track.