FibroGen secured regulatory approvals for roxadustat in China and Europe, but the FDA rejected the drug and asked for another clinical trial. By selling its China business to AstraZeneca, FibroGen can focus on developing a prostate cancer drug and potentially resuming development of roxadustat in another indication.
AstraZeneca’s Datroway, an antibody drug conjugate (ADC), is now FDA approved for advanced cases of breast cancer that is HR positive and HER2 negative. Datroway targets TROP2, the same cancer protein addressed by Trodelvy, a Gilead Sciences ADC also approved for breast cancer.
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AstraZeneca’s Calquence has expanded its FDA approval to include first-line treatment of mantle cell lymphoma. The regulatory decision makes Calquence the first BTK inhibitor approved as an initial treatment for this type of blood cancer.
Cardiovascular disease drugs in development intended to reduce lipoprotein (a) are mostly injectable medications, though Eli Lilly has both oral and injectable drugs in the clinic. AstraZeneca aims to hit that key protein target with an oral small molecule licensed from CSPC Pharmaceutical Group.
AstraZeneca’s Tagrisso and Imfinzi helped patients live longer in separate pivotal clinical trials evaluating the drugs in two different types of lung cancer. The results will be presented Sunday during the annual meeting of the American Society of Clinical Oncology.
Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders.
Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all.
The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029.
The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.
The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.
AstraZeneca’s Fusion Pharmaceuticals acquisition is the latest in a wave of M&A activity that includes recent deals by Eli Lilly and Bristol Myers Squibb. The lead Fusion program is in mid-stage clinical development for treating advanced prostate cancer.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug.
A federal judge disagreed with AstraZeneca’s claims that the Inflation Reduction Act causes harm by disincentivizing innovation and violates its constitutional rights to due process. Blockbuster AstraZeneca drug Farxiga is one of 10 medications selected for the Medicare drug price negotiation program created by the law.
AstraZeneca is paying $1 billion up front to acquire Gracell Biotechnologies, a clinical-stage cell therapy developer. The deal is the latest in a series of AstraZeneca moves intended to expand its presence in the burgeoning cell therapy field.
AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax's pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults.
The FDA approved AstraZeneca’s Truqap as a new treatment for advanced cases of breast cancer. The drug is the first in a new class of therapies addressing AKT genetic alterations.