The U.S. government has requested that a Delaware federal judge deny an AstraZeneca motion for summary judgement in its Inflation Reduction Act case, arguing that the company’s core claims are meritless.
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The deal is aimed at speeding up the development of therapeutics in areas including oncology, immunology and rare diseases.
The companies presented data from two pivotal studies of Dato-DXd, focusing on safety concerns and survival data for the investigational antibody-drug conjugate candidate in lung and breast cancer.
If approved, the vaccine – branded as FluMist Quadrivalent – could become the first self-administered flu vaccine which does not necessitate a healthcare practitioner for administration.
Jefferies analyst Stephen Barker said in a note the data was “worse-than-expected”, citing that treatment with the drug only improved the time patients with non-small cell lung cancer live without their disease worsening by 0.7 months compared to chemotherapy.
The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the decision from the regulator was based on a late-stage trial which extended median progression-free survival (PFS) by nearly nine months.
Pharma companies are striving to convey the true impact of diseases on patients while continuing to empower them.
As the COVID-19 pandemic continues to recede, the top pharma companies intensified their focus into areas such as cancer and metabolic diseases to build up their pipelines, and their growth prospects, for the future.
For AstraZeneca, the approval of Enhertu last year marked one of the high points in the company’s scientific program.
All 10 pharmaceutical companies whose products were selected for the first round of Medicare drug price negotiations have agreed to participate in the talks, the Department of Health and Human Services announced Tuesday.
