Research & Development

Do US FDA’s efforts at simplifying the biosimilar pathway create more competition and threaten Aurobindo Pharma's return on investments? Management speaks on this, biosimilar filing plans and deal strategy at the Q2 FY26 earnings call

With another regulator now considering the removal of clinical efficacy trials for biosimilars, BioPharmaSpec’s technical director Richard Easton paints the picture of data-powered biosimilarity assessment.

Launched in April 2025, Astellas’s Innovation Lab unites fragmented research units under Morten Sogaard to pursue focused indications, a dual-track R&D strategy and tailored partnerships that balance innovation, risk and collaboration.

Newly revealed data on HLX43’s recommended Phase II/III dose has boosted Henlius’s confidence to launch up to eight Phase III trials of the ADC in lung cancer. Phase III trials of the agent in more cancer types are also on the horizon.

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

Alteogen's preparations to move its stock listing, ABL Bio's injection of funds into its US subsidiary to progress clinical trials and Ensol's plans for a Phase III trial of its osteoarthritis contender are among key recent developments in Korean biotech.

Dave Wendland retires after 34 years at HRG; AHPA science chief Holly Johnson earns WIN Guiding Star; Strategy, people leads for Vitamin Shoppe; CDMO Kenox appoints R&D, manufacturing VP; and contract manufacturer Radienz adds customer chief.

The Swiss major plans to submit the positive results from the NEPTUNUS program to health authorities globally in early 2026.

A new 10-year, government-supported R&D program in China will focus on new targets and emerging technologies which can be translated into first-in-class drugs and give birth to top players in the global pharma industry.

A new 10-year, government-supported R&D program in China will focus on new targets and emerging technologies which can be translated into first-in-class drugs and give birth to top players in the global pharma industry.

The Basel-based company has faith in its existing rare disease commercial platform to successfully market the newly-acquired assets.

Four organizations pursue distinct virtual cell strategies: Xaira emphasizes perturbational data, CZI builds modular foundations, Recursion integrates lab-in-loop validation, Noetik starts with patient tissue for drug discovery.