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14,136 Results for "astrazeneca".
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Approvals
AstraZeneca’s Imfinzi-Lynparza Combo Wins Landmark EU Nod for Endometrial Cancer
The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
August 14, 2024
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2 min read
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Tristan Manalac
Cancer
AstraZeneca’s Calquence Aces Phase III CLL Trial, Eyes Fixed-Duration Approval
AstraZeneca is seeking a fixed-duration approval for Calquence, which will allow patients with chronic lymphocytic leukemia to take breaks from the therapy and prevent excessive toxicities and drug resistance.
July 30, 2024
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2 min read
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Tristan Manalac
Adcomms
FDA Flags Potential ‘Overtreatment’ for NSCLC With AstraZeneca’s Imfinzi Ahead of Adcomm
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
July 24, 2024
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2 min read
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Tristan Manalac
Antibody-drug conjugate (ADC)
AstraZeneca, Daiichi Sankyo Turn to AI to Explain Phase III NSCLC Miss for Dato-DXd
Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker.
September 9, 2024
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2 min read
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Tristan Manalac
Patents
Delaware Judge Throws Out Pfizer’s $107.5M Tagrisso Patent Win Over AstraZeneca
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
August 16, 2024
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2 min read
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Tristan Manalac
Drug Development
AstraZeneca’s Imfinzi Fails Phase III NSCLC Trial, Aces Late-Stage Bladder Cancer Study
AstraZeneca’s PD-L1 inhibitor failed to significantly improve disease-free survival in patients with non-small cell lung cancer, but hit its primary endpoint in a late-stage trial in muscle-invasive bladder cancer.
June 25, 2024
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2 min read
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Tristan Manalac
FDA
Amgen Wins FDA Approval for First Biosimilar to AstraZeneca’s Soliris
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
May 29, 2024
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2 min read
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Tristan Manalac
FDA
AstraZeneca’s Imfinzi Gets FDA Approval for Treating Endometrial Cancer
AstraZeneca on Monday secured FDA approval for its blockbuster Imfinzi, in combination with chemotherapy, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.
June 17, 2024
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2 min read
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Tyler Patchen
Drug Development
AstraZeneca’s Truqap Flops in Phase III Triple-Negative Breast Cancer Trial
Bucking its recent winning streak in oncology, AstraZeneca reported Tuesday that its AKT inhibitor Truqap failed to significantly boost overall survival in patients with triple-negative breast cancer.
June 18, 2024
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2 min read
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Tristan Manalac
IRA
AstraZeneca Appeals IRA Loss, Reiterates Constitutional Challenge to Drug Price Negotiations
AstraZeneca joins Johnson & Johnson and Bristol Myers Squibb in appealing a previous legal loss for its challenge to the government’s drug price-setting program.
July 17, 2024
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2 min read
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Tristan Manalac
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