Oncology

The FDA granted accelerated approval for the small but significant HER2-mutated NSCLC indication, while the arbitrator in Seagen’s arbitration case ruled in Daiichi Sankyo’s favor.

The company has filed its first drug in the UK and initiated a US-based Phase III trial; US drug pricing legislation underscores the company's value proposition, CEO says.

Emerging Company Profile: The French firm, which is developing the lead CTP synthase 1 inhibitor in the pipeline, plans to address a range of cancers with its highly selective approach.

The company presented data for its bispecific antibody tarlatamab at WCLC, drawing noticeably more excitement than highly anticipated but disappointing data for Lumakras with checkpoint inhibitors.

The UK major has teamed up with the US biotech to develop the latter’s HER-2 targeted antibody-drug conjugate, a couple of years after the approval of Blenrep, in what is becoming an increasingly competitive space.

Data presented during the weekend at WCLC for Lumakras with Keytruda or Tecentriq raised questions about elevated liver toxicity and a lackluster response rate.

Analysts are scratching their heads over what direction the Belgian biotech will take in the coming months and years, with all eyes on an R&D day in October.

AstraZeneca and partner Daiichi Sankyo obtain the first approval for targeted therapy in HER2-low metastatic breast cancer for Enhertu, about four months ahead of the FDA action date.

The antibody-drug conjugate market is emerging as the next battleground for intense competition in China, with global partnerships becoming essential to win, as evidenced by a major new alliance between Innovent and Sanofi.

Just over a month after raising $97m in a series B round, Oxford University spinout MiroBio and its immune checkpoint agonists have been snapped up by Gilead Sciences. 

The costimulatory bispecific antibody REGN5678, meant to turn “cold” prostate cancer tumors “hot” and vulnerable to PD-1 inhibitors, showed early signs of efficacy combined with Libtayo.

The Japanese firm has expanded its partnership with AbbVie into the neurology space, where it hopes to use its unique platform technology to develop up to three drug candidates targeting ‘challenging’ G protein-coupled receptor targets.