Drug Development

CPHI Americas 2026 tackles pharma's pressing challenges such as: regulatory shifts, AI in drug discovery, biologics innovation, and supply chain resilience.

Regeneron and Telix announce a 50/50 radiopharma collaboration, combining antibody expertise with specialized manufacturing to develop next-generation cancer therapies.

European Biotechs are utilizing AI and precision medicines to improve the personalized treatment of cardiovascular disease.

FDA rejects Replimune's melanoma therapy despite breakthrough designation, raising urgent questions about regulatory consistency and accelerated approval pathway reliability.

This week, PharmTech discussed proactive, data-driven contamination control, solving manufacturing hurdles, and the market entry of complex generics and biosimilars.

BMS and Oxford BioTherapeutics partner to develop tumour-selective T-cell engagers, signalling pharma's growing reliance on specialist discovery platforms.

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and generic-drug developers.

Biocon launches two FDA-approved interchangeable denosumab biosimilars in the US, targeting osteoporosis and bone metastasis in a $5B market.

This article details what co-processed excipients are and how they are made.

Gene therapy AFTX-201 advances into multinational clinical trials, targeting the genetic root cause of BAG3-associated dilated cardiomyopathy with an engineered capsid.

Indirect data suggest oral semaglutide outperforms orforglipron on weight loss and tolerability, with patients also favoring its treatment profile.

The FDA approves orforglipron (Foundayo), the first oral, non-peptide GLP-1 for obesity, the fastest NME approval under the new CNPV program.

Lilly acquires Centessa for $6.3B, gaining an orexin receptor agonist pipeline targeting narcolepsy and other sleep-wake disorders.

The agency has issued a draft qualification opinion on a new preclinical research methodology.

Lilly licenses Insilico's AI drug discovery platform in a deal worth up to $2.75B, signaling a shift in how novel therapeutics are identified.

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer, relapsed extensive-stage small cell lung cancer, activated phosphoinositide 3-kinase delta syndrome, and oedema of cardiac, renal, hepatic origin, and hypertension in children.

Excipients contribute to more sustainable practices throughout the life cycle of a drug.

EMA approved Johnson & Johnson’s daratumumab SC for self-administration, Europe’s first oncology injectable to offer this treatment flexibility.

Merck acquires Terns Pharmaceuticals for $6.7B, gaining TERN-701, a promising oral CML therapy with a novel mechanism and early Phase I/II clinical data.

European biotech companies are exploring new therapeutic targets on T-cells to overcome drug resistance and improve clinical outcomes in cancer.

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.

The new €3.2M (US$3.7M) research lab will investigate immunogenic cell death mechanisms in lung cancer to improve how existing therapies trigger immune response.

Rare disease drugs are forecast to exceed $400B by 2032, driven by policy shifts and pipeline growth, despite competition from large-indication products.

The two companies have entered into a licensing agreement to commercialize biosimilars in Latin America.

FDA approves leucovorin for cerebral folate deficiency, signaling how literature-based evidence can support rare disease approvals without clinical trials.