AstraZeneca Pharmaceuticals LP
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The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.
The regulator’s approval means AstraZeneca’s Tagrisso can now be used in combination with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer patients.
Thursday’s full-year financial results from AstraZeneca showed a revenue crash of more than 90% for COVID-19 medicines, while cancer, cardiovascular and rare diseases all generated double-digit revenue growth.
All three companies closed out the year, which saw significant growth in mergers and acquisitions, with high-value deals that could potentially set the tone for M&A in 2024.
Wainua, which is jointly developed and commercialized by AstraZeneca and Ionis Pharmaceuticals, was given the FDA’s green light on Thursday and will now compete with Alnylam’s two approved hATTR-PN therapies.
At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.
The year may be coming to a close, but there’s no holiday break for the FDA, which will release five regulatory verdicts over the next two weeks.
With the acquisition, AstraZeneca will gain access to Icosavax’s investigational combination vaccine IVX-A12, which is being developed for respiratory syncytial virus and human metapneumovirus in older adults.
In the latest example of big pharma entering AI collaborations or using AI-based tools, AstraZeneca’s deal with Absci will aim to produce an oncology candidate.
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