Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement. News of the withdrawal comes more than a month after the May 23 Qdenga PDUFA date. The future plan for Qdenga in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionyx, Adial, Genentech, Hansa, Lupin, Pulmatrix, Quralis, Renibus, Roche, Salarius.
The tension of clashing politics, policies and prescription drug pricing is coming to a head as U.S. Sen. Bernie Sanders (I-Vt.) acts on his threat to hold presidential appointments in the health arena hostage until President Joe Biden commits to do more to bring down drug prices.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arctic Vision, Biophytis, Hemogenyx, Iovance, Marker, Myopax, Sensorion, Spinogenix.
China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 28 Bio, Bioarctic, Epicentrx, Ichnos, Ips Heart, NS, Transcenta.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Astellas, Curis, Kazia, Kyverna, Merus, Novavax, OSE, Sihuan.
The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space.
The Association for Accessible Medicines fired off a constitutional challenge in U.S. federal court July 5 to provisions included in Minnesota’s new budget law that would restrict price increases for generic and off-patent drugs.
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