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Today, a brief rundown of news involving Daiichi Sankyo, Agenus and Amgen, as well as updates from the U.S. PTO, Bluebird bio and Merus that you may have missed.
AstraZeneca and Daiichi Sankyo on Friday revealed new study results supporting their revised approval plans for the closely watched cancer drug datopotamab deruxtecan, or dato-dxd. A pooled analysis from two clinical trials showed dato-dxd kept tumors in check for a median of about six months in people whose non-small cell lung tumors were driven to growth by mutations in the EGFR gene. Among 117 people, median survival was 15.6 months, according to a statement. The findings underpin an accelerated approval filing the partners submitted last month in EGFR-mutated lung cancer — a much narrower request than they’d originally anticipated. — Ben Fidler
Agenus will cut yearly spending by 60% to focus resources around a cancer immunotherapy combination that’s approaching late-stage testing in colorectal cancer, the company said Thursday. The company will implement “significant cost-cutting measures,” including layoffs and other unspecified adjustments, to lower its cash burn to $100 million for the 2025 fiscal year. Agenus has been streamlining costs since last year, when it laid off 25% of its workforce, and has said its restructuring initiatives are a “bridge” to a forthcoming “strategic transaction designed to deliver substantial resources.” — Ben Fidler
Amgen said Thursday it will invest another $1 billion to expand its manufacturing footprint in Holly Springs, North Carolina. The new investment builds on a previously announced $550 million commitment and will add a second drug substance manufacturing facility that will employ about 370 people. Amgen has already boosted its drug production capabilities this year, having opened a production plant in Ohio in February. It didn’t say when the new Holly Springs facility will begin operating. — Delilah Alvarado
The U.S. Patent and Trademark Office is withdrawing a controversial proposed rule that aimed to prevent so-called “patent thickets” around pharmaceutical products that can deter price competition from generic and biosimilar drugs. A notice published Wednesday cited “resource constraints” as a reason for pulling the rule after it received 349 comments. In the proposed rule, the PTO sought to reduce the legal burden on companies challenging intellectual property by narrowing the case to just the original inventions and not “obvious” variations on which the patent owner may have also claimed legal exclusivity. — Jonathan Gardner