Drug Development

Sandra Coufal, MD, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of the oral cancer drug.

2026 regulatory shifts are accelerating rare disease drug approvals and reshaping clinical development, evidentiary standards, and pharmaceutical manufacturing strategies.

Bristol Myers Squibb’s Hengrui agreement underscores how China-based early development may influence portfolio and manufacturing decisions.

This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, the rise of advanced modalities, and the integration of flexible, tech-enabled infrastructure.

Lilly expanded its Indiana manufacturing investment by $4.5 billion to support tirzepatide, oral glucagon-like peptide-1, and genetic medicines.

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the workshop, Risk Based Framework for Development of New Excipient Products, at Excipient World 2026.

High-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.

FDA approves AstraZeneca's Breztri as the first single-inhaler triple therapy for asthma in patients 12+, a new precedent for respiratory drug developers.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.

FDA grants full approval to sparsentan for FSGS, the first-ever treatment for the rare kidney disease, backed by Phase III data showing 48% proteinuria reduction.

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.

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.