Guardant Health Announces Landmark FDA Approval of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced Breast Cancer

Guardant Health (GH) was ordered to pay $245.2M for patent infringement, with a 6% royalty on US sales of 11 products until 2033. The company plans to appeal, noting current versions of Reveal and Shield are excluded. The judgment includes $83.4M in damages, $19.5M in supplemental damages, $119.4M in royalties, and $22.9M in interest.

AstraZeneca's ETCAMAH® (camizestrant) in combination with a CDK4/6 inhibitor received FDA approval for 1st-line advanced HR-positive breast cancer. The approval was based on the SERENA-6 Phase III trial, which showed a 56% reduction in the risk of disease progression or death. The treatment is the first of its type in the 1st-line setting and has the potential to reshape treatment paradigms for this form of advanced breast cancer. AstraZeneca has received its tenth FDA approval this year, with f

The FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant) for treating advanced breast cancer with ESR1 mutations. The approval was based on a clinical trial showing 16-month median progression-free survival. The FDA required confirmatory studies to verify clinical benefit. The approval includes a companion diagnostic test, Guardant360 CDx, for identifying eligible patients.

Ionis (IONS) and Milestone (MIST) gained FDA approvals for neurology and cardiology drugs. Biogen (BIIB) and AstraZeneca (AZN) also received regulatory nods for Alzheimer's and cancer treatments. Novavax (NVAX) secured global approvals for its COVID-19 vaccine. TScan (TCRX) and Novartis (NVS) announced job cuts. Novartis (NVS) and HUTCHMED (HCM) struck deals worth up to $3.2B and $1.295B respectively.

AstraZeneca and Amgen reported positive phase 3 trial results for tezepelumab (Tezspire) in treating eosinophilic esophagitis (EoE). The study showed improved dysphagia and histologic remission at weeks 24 and 52 compared to placebo. The companies plan to share data with regulators. Tezspire is already FDA-approved for severe asthma and chronic rhinosinusitis.

AstraZeneca and Amgen's TEZSPIRE met primary endpoints in a Phase III trial for eosinophilic esophagitis, showing significant improvements in histologic remission and dysphagia symptoms. The drug maintained efficacy through 52 weeks, with results planned for regulatory submission. TEZSPIRE is approved for severe asthma and chronic rhinosinusitis with nasal polyps.