Today, a brief rundown of news involving Astellas Pharma and Moderna, as well as updates from AstraZeneca, Daiichi Sankyo and Gilead Sciences that you may have missed.
Astellas Pharma is planning new cost cuts as part of a strategic plan to achieve “sustainable growth” following the loss of patents protecting its prostate cancer drug Xtandi. The Japanese pharma giant didn’t disclose specifics about the coming cuts, but said on Tuesday that, between previous and planned initiatives it’s aiming for about $1.3 billion in cumulative yearly savings between the 2026 and 2030 fiscal years. Astellas also intends to use dealmaking to purchase “synergistic assets” and may pursue a “large-scale” acquisition to protect its revenue in the near-term, according to an investor presentation. Often, sweeping cost-cutting plans as well as "synergistic" acquisitions lead to layoffs.
The Food and Drug Administration will convene a panel of outside advisers to debate the merits of Moderna’s experimental messenger RNA-based shot for influenza. A rare occurrence under the Trump administration, the June 18 meeting will involve discussions about the safety and effectiveness of what Moderna is now calling mFlusia, a vaccine it hopes to market as a preventive shot in people at least 50 years of age. The FDA initially refused to review Moderna’s application before quickly changing course earlier this year.
The FDA additionally widened use of AstraZeneca and Daiichi Sankyo's Datroway, clearing it on Friday to treat certain patients newly diagnosed with metastatic, triple-negative breast cancer. The approval makes Datroway available specifically to people who are ineligible for a commonly used immunotherapy, a group AstraZeneca estimates to cover about 70% of those with triple-negative disease. It was based on a study showing Datroway helped cut the risk of death by 21% compared to chemotherapy. Datroway was previously OK'd for use in people with certain HR-positive, HER2-negative breast tumors as well as EGFR-mutated lung cancers.
The agency on Friday also granted an accelerated clearance to Hepcludex, a medicine Gilead Sciences has developed for chronic hepatitis D infections. Formerly known as bulevirtide, the drug showed in testing the ability to suppress levels of the virus in the blood as well as lower key markers of liver inflammation. Chronic hepatitis D is considered the most severe form of viral hepatitis and is associated with a far higher risk of liver failure and death than hepatitis B. Hepcludex is now the first FDA-approved treatment for the condition, which Gilead estimates to affect some 40,000 to 80,000 people in the U.S.
