Policy
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported.
Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis.
Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment.
After finally getting the green light from the Federal Trade Commission last month, Amgen has completed the buyout and expects to provide updated fiscal year 2023 guidance during its third-quarter earnings call.
Data from a confirmatory study could not be reliably interpreted, according to the Oncologic Drugs Advisory Committee, which voted against Amgen’s request for full approval of its G12C KRAS inhibitor.
Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
Following a fatality due to the rare blood disease hemophagocytic lymphohistiocytosis, the regulator slapped a partial clinical hold on two studies of Innate Pharma’s investigational therapy lacutamab.
Despite the lack of a randomized controlled trial for US WorldMeds’ investigational drug, an FDA advisory committee found that the company provided adequate data to support its benefit in high-risk neuroblastoma.
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
In its briefing document for Thursday’s FDA advisory committee meeting, the regulator contends that the company’s confirmatory CodeBreaK 200 trial for Lumakras is not an “adequate and well-controlled” study.