Drug Development

The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.

The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.

Swedish biotech companies have a broad and varied product pipeline that is attracting attention from venture capitalists and pharmaceutical companies.

The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.

The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.

Christy Owings, Thermo Fisher, explains clinical trial supply chain risks in Latin America, importer-of-record strategy, AI, and eCOA delays.

The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.

FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.

2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.

Sanofi will transfer 20 mature medicines and three manufacturing sites to Cheplapharm for a 26.4% equity stake, closing by Q3 2027.

Christy Owings, Thermo Fisher, on how AI complements clinical supply chain expertise, streamlines site logistics, and tracks shifting biotech markets.

Christy Owings, Thermo Fisher, speaks on why importer of record strategy and vetted local partners are key to reliable clinical trial supply chains.

Christy Owings, Thermo Fisher, discusses how customs delays and import complexity risk clinical trial supply chains in Latin America.

This week saw predictive modeling, microstructure intelligence, a CAR T-cell safety pause, and major licensing deals reshape pharma manufacturing.

The FDA approves zilganersen, the first disease-modifying Alexander disease therapy, offering rare disease developers a trial design and RNA delivery model.

PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about what’s new for CPHI Milan this year, including 4 new zones and a Sustainability Summit.

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.