Clinical Trials

Novartis president, development and chief medical officer talks about the pivotal role of the development India hub in progressing breakthrough drugs, how AI is delivering gains in the trials arena, driving focus in the R&D engine and the Swiss group’s approach in the obesity space.

Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.

Parexel's CEO Peyton Howell and India boss Sanjay Vyas talk to Scrip about the value of clinical trial diversity, AI pilots underway and opportunities for India amid geopolitical rumblings, as well as the need for standardized regulatory approaches to enhance sponsor interest.

Adial Pharmaceuticals’ CEO Cary Claiborne discussed with Generics Bulletin how repurposing antinausea drug ondansetron and genetically targeting patients with specific biomarkers can address the unmet need in the current treatment of addiction.

Harness Therapeutics' CEO talked to In Vivo about the company's strategy for expansion and partnering in the neurodegeneration space.

A US tariff on imports from China raises the spectre of similar action against India, but Aurobindo, the largest generics company in the US by prescriptions dispensed, assures it has alternatives in place. While trials for an opthalmology biosimilar are delayed, supply of other biosimilars to Europe is set to begin in Q2 FY26

Sionna essentially doubled its cash on hand with its initial public offering to go up against a formidable competitor in cystic fibrosis with novel medicines applicable to a broad population.

The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.

Bristol Myers Squibb has been in a rapid growth phase to make up for upcoming losses of exclusivity. Scrip spoke with executives about further catalysts coming in the next 18-24 months.

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.