News
Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.
FEATURED STORIES
While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing.
Job Trends
For reasons including downsizing, avoiding retirement and a tight labor market, senior-level biopharma professionals are increasingly turning to fractional roles, according to two recruitment experts.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
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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.
The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward.
The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.
Takeda wanted to create something new in the cell therapy world by combining the technology with T cell engagers. A series of acquisitions in 2021 started the process.
As the industry loses one of its key female leaders in GSK CEO Emma Walmsley, BioSpace profiles the women leading the industry’s smaller biopharmas.
Drug pricing criticism often fixates on a price at a single point in time but drug pricing is never static.
Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.