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The centerpiece of the takeover is anito-cel, a CAR T therapy under development for relapsed or refractory multiple myeloma. An FDA decision on the therapy is expected by December 2026.
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Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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GoodRx, an online platform that offers drug discount coupons to patients, is in talks with the government to participate in the forthcoming TrumpRx program.
The British proposal to increase support for pharma is “clearly positive,” according to analysts at Leerink, who noted that the NHS’ move will improve patient access to treatments.
Novo will add Akero’s efruxifermin to its MASH portfolio, which includes Wegovy after the GLP-1 gained an FDA nod in the indication earlier this year.
The CDC’s Advisory Committee on Immunization Practices was scheduled to convene Oct. 22 to 23, but this meeting has been postponed, with no new date specified. The delay comes as the VA published new research showing that COVID-19 shots prevented hospitalizations and death.
The layoffs are part of the company’s shift to a new structure enabling cost efficiency for its new model.
Looking for a job in oncology? Check out the BioSpace list of nine companies hiring life sciences professionals like you.
New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.
Sanofi’s Orano Med-partnered radioligand therapy AlphaMedix achieved all primary efficacy endpoints, which included a measure of overall response rate, in the mid-stage ALPHAMEDIX-02 study.
The centerpiece of the deal is orelabrutinib, a BTK inhibitor in late-stage development for multiple sclerosis that Biogen once paid $125 million for but abandoned after less than two years of testing.
In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.