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Oncology

Set Alert for Oncology

Daiichi Sankyo/AstraZeneca Get Two Lucky Breaks For Enhertu

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.

Approvals Legal Issues

EQRx Revises Plans To Get Chinese Licensed Drugs To US Market

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.

Clinical Trials FDA

Step Pharma Aims To Become CTP Synthase 1 Leader, Starting With Aggressive Lymphoma

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.

Emerging Company Profile Companies

Third-Line’s A Charm: Amgen Aims To Take A BiTE Out Of Pretreated SCLC

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.

Cancer ImmunoOncology

GSK Makes ADC Pipeline Comeback With Mersana Deal

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.

Companies Deals

Can Amgen Balance Efficacy, Safety With KRAS/PD-1 Combination?

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

ImmunoOncology Business Strategies

Galapagos Keeps Analysts Guessing About Future Plans

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.

Sales & Earnings Clinical Trials

Enhertu Goes Into High Gear With HER2-Low Breast Cancer Approval

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.

Approvals Personalized Medicine

Sanofi, Innovent Link On China Oncology Ambitions As ADCs Surge

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.

China Deals

Gilead Grabs MiroBio's Checkpoint Agonists For $405m

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. 

M & A Immune Disorders

Regeneron’s Oncology Strategy Gets Warmer With Early Prostate Data

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.

Sales & Earnings Business Strategies

Sosei Bolsters GPCR Focus With AbbVie Neurology Deal

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.

Deals Cancer
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