The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.
Takeda Pharmaceutical gains full rights to a small molecule that has shown promise treating seizures in several rare forms of epilepsy. Meanwhile, Ovid Therapeutics gains cash to support its pipeline of neurological disease drug candidates.
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The clinical trial had already been placed on hold in connection with the two prior patient deaths, which were linked to the higher dose of 300 trillion viral vectors per kilogram, while no deaths have been reported among those receiving the lower dose of 100 trillion vectors.
Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen's stock rose 10%, but analysts had mixed opinions.
Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.
The companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed last year for another ADC, the HER2-positive breast cancer drug Enhertu.
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The company disclosed in a letter to the X-linked myotubular myopathy patient community that a second child in its Phase I/II study had died. A formal clinical hold has been placed on the trial.
The Japanese drugmaker had entered a neurology-focused partnership with Allergan in April 2016. AbbVie acquired Allergan last year, closing the deal in May.
It was also reported that a study sponsored by the National Institutes of Health was running ahead of schedule and could have data available in the next couple of weeks.
Politico reported Tuesday that the Trump administration is trying to secure an emergency use authorization from the Food and Drug Administration for Fujifilm's Avigan. The FDA gave an EUA to two unproven antimalarial drugs over the weekend.
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The voluntary withdrawal was in response to an FDA request. Eisai said its interpretation of the data differed from the agency's, but the drug's original developer had called off pursuit of European approval when regulators there pointed to potential tumor risk from long-term use.
The companies said Monday that they would partner to develop small-molecule oncology drugs against several targets, including KRAS mutations, long thought "undruggable." Amgen and Mirati have already presented clinical data from their KRAS programs.
The deal comes less than a month after the Japanese drugmaker said it would spend $3 billion to acquire gene therapy developer Audentes Therapeutics.
The drug, Enhertu, is the subject of an ongoing legal dispute between Daiichi Sankyo and Seattle Genetics, which alleges that the Tokyo-based drugmaker used its technology. The two had a partnership from 2008-2015.
Shares of Audentes rose more than 100% following news that the Japanese drugmaker would acquire it. The company's lead candidate is a gene therapy for a rare muscular weakness disorder, currently in a Phase I/II study for which it presented data in October.