Sputnik V Cleared in India, Trajectory Against Variants May Be Key

Bharat Serums showed it’s possible to score a regulatory win with real-world evidence (RWE) studies in India when it ran one leading to a label expansion for its mAb trinbelimab. As cell and gene therapies and rare disease drugs gain currency, sponsors could look at takeaways from the RhYTHM study.

Novartis’s APMA chief outlines the company’s tailored approach to deliver long-term outcomes, novel access solutions via innovative financing options and shape the CVD ecosystem in the extraordinarily diverse region. Partnering to build AI infrastructure is another key prong.

Lupin’s poster presentation at the upcoming ESMO Congress is set to highlight that its STING agonist candidate demonstrated safety in a Phase Ia trial. The question is whether it will be able to strike a deal like IFM Therapeutics did with Novartis or Mersana did with Merck KGaA

Roche, which faced a high stakes patent setback for Evrysdi in India, appears to have appealed against a lower court’s ruling, which went decisively Natco’s way but also included distinct 'reservations' by the judges.