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What’s in Today’s Brief? (June 30th Preview)
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US probes foreign trial practices for major drugmakers
A U.S. House committee has opened an investigation into Merck and AbbVie over their China clinical trial practices, according to the latest report on the probe. The inquiry targets the use of trial sites in China, including facilities alleged to have links to the Chinese military. Separately, another item notes a House China panel inquiry into Bristol Myers Squibb and Pfizer over similar trial-site questions. Together, the actions signal heightened scrutiny of where and how pivotal and late-stage studies are conducted as regulators and lawmakers push for clearer data integrity and ethical compliance standards. For biotech and pharma, the immediate risk is regulatory and litigation exposure tied to trial conduct allegations, plus potential delays if sponsors are forced to reexamine datasets, informed-consent documentation, and site qualification processes in challenged geographies.
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FDA gene therapy regulator exit triggers leadership transition
Vijay Kumar, the acting FDA gene-therapy regulator overseeing cell and gene therapies within CBER’s Office of Therapeutic Products, is stepping down from the role after roughly a year in the position. FDA leadership said Karim Mikhail will assume direct oversight of the office during the transition, while the agency plans to advertise the permanent director opening. Kumar’s move follows broader CBER leadership churn in the past year, including departures and reversals of prior regulatory decisions under changing oversight. The timing may matter for biotech programs preparing submissions or already in review queues for advanced therapies. For companies, the near-term impact to watch is whether review timelines and agency expectations remain stable while the FDA transitions to a new permanent leader.
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Controversy expands around Amgen’s Tavneos clinical evidence
The New England Journal of Medicine has retracted Tavneos (avacopan) pivotal phase 3 study data after an FDA investigation concluded primary endpoint assessments were readjudicated after database lock and trial unblinding without disclosure in the original article. The retraction deepens Amgen’s challenge as the FDA reassesses the drug’s risk-benefit profile and pushes toward market withdrawal. Tavneos was approved in 2021 for ANCA-associated vasculitis; the pivotal trial work traces back to ChemoCentryx before its $3.7 billion sale to Amgen. Earlier, FDA staff already raised concerns with the study conduct, which contributed to turmoil for investors. The retraction sets up a more complicated dispute path for Amgen, as the company resists a withdrawal and gears for an FDA hearing, including sharing endpoint re-adjudication work with regulators.
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Abivax reassures on ulcerative colitis safety after cancer signals
Abivax moved to calm investor concern over its ulcerative colitis candidate obefazimod by disclosing additional safety data, indicating cancer cases in a Phase 3 setting were within the expected range for the trial population. The update follows a period when new cancer reports triggered a sharp stock selloff. Analysts and investors are watching whether the safety signal can be contained well enough to support ongoing regulatory and commercial expectations. The company’s messaging frames the new data as consistent with what would be expected for these patients. For biotech leaders, the development underscores how quickly safety interpretations can swing sentiment in late-stage inflammatory disease programs—and how fast companies must deliver credible follow-up datasets.
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New antibody-drug combo readout strengthens Epkinly strategy in DLBCL
AbbVie and Genmab touted results from a Phase 3 combination study for Epkinly (epcoritamab) after a prior monotherapy setback in diffuse large B-cell lymphoma. In the Epcore DLBCL-4 trial, Epkinly plus lenalidomide cut the risk of progression or death by 60% versus R-GemOx, meeting the trial’s primary endpoint. The companies also highlighted the safety profile as consistent with prior experience and noted a progression-free survival improvement of 56% for non-U.S. regulators using a comparable analysis approach. No overall survival results were disclosed in the initial release. With another high-stakes readout expected in Epcore DLBCL-2 for first-line disease, this update reframes the Epkinly outlook toward combination strategy and intensifies competitive pressure in second-line lymphoma after prior FDA refusals for competing bispecific regimens.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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