Regulatory
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.
Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.
An FDA advisory committee this week voted overwhelmingly against BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis treatment. However, other potential therapies offer hope for ALS patients.
The FDA will kick off October with an advisory committee meeting for Amgen’s Lumakras and target action dates for Alnylam’s patisiran and Bristol Myers Squibb’s Opdivo.
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